Nutritional Counseling
The Effects of Physical Activity and Nutritional Counseling on Smoking Cessation Among Low Income African American Smokers – Randomized Control Trial
Group 3
Table of Contents
Project Abstract……………………………………………………………………………..… 3
Project Narrative…………………………………………………………………………….… 4
Facilities/Equipment………………………………………………………………………..… 5
Biosketches……………………………………………………………………………………. 6
Specific Aims…………………………………………………………………………….…... 11
Research Plan………………………………………………………………………………… 12 Background and Significance………………………………………………..….… 12 Approach…………………………………………………………………………….. 14 Hypothesis………………………………………………………………….. 14 Design and Randomization……………………………………………….. 14 Recruitment…..................................................................................... 14 …show more content…
Inclusion/Exclusion…………………………………………………..…... 15 Treatments…...................................................................................... 15 Outcomes…………………………………………………………………... 16 Sample Size………………………………………………………………... 17 Analysis………………………………………………………………….…. 18 Investigators and Environment………………………………………………….... 21 Timeline and Milestones…………………………………………………..………. 22
References…………………………………………………………………………..……..… 23
Human Subjects Protection………………………………………………………...……... 26
Appendices………………………………………………………………………………….. 31 Recruitment Plan……………………………………………………………..……. 31 Consent Form……………………………………………………………….….….. 32 Data Management………………………………………………………………..... 37 Randomization Pattern…………………………………………………………….. 38
Project Abstract
Smoking is the leading cause of preventable death in the United States, accounting for approximately 443,000 deaths, or 1 of every 5 deaths, each year. In fact 50% of smokers will die from smoking related causes. National statistics showed that African Americans have one of the highest prevalence of cigarette smoking (20.6%) after white non-Hispanics (21%). According to the CDC, African Americans represented the second highest proportion of cigarette smokers (28.7%) in Allegheny County. Many studies have shown that exercise decreases smoking withdrawal symptoms, but it is unclear if exercise could have similar results among African Americans.
We will examine the addition of physical activity and nutritional counseling to the standard treatment for smoking cessation among low-income African Americans in Allegheny County.
Our hypothesis is that low-income African American smokers, randomized to participate in the physical activity intervention arm, will have higher rates of smoking cessation, significant weight loss, less withdrawal symptoms and longer periods of abstinence after one year.
The proposed study will be a prospective randomized controlled trial. We will use a parallel design with two treatment arms and will follow participants for 12 months. Both arms will receive the standard treatment (nicotine replacement therapy and smoking cessation counseling). In addition, the intervention arm will include physical activity and nutrition counseling. We will request the participants to engage in moderate physical activity for 150 minutes per week and we will collect the number of steps counts and weekly activity …show more content…
minutes.
Willingness to change behaviors related to physical activity and nutrition will be measured via the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE). The EuroQol Group EQ-5D-3L will be used to measure their perceived health status. Smoking cessation will be assessed by measuring carbon monoxide levels and levels of cotinine in the urine. Withdrawal symptoms will also be measured using the Minnesota Nicotine Withdrawal Scale. Additionally, weight loss will be assessed as a percent weight loss from weight at baseline. In our sample size we expect a 75% retention rate, when the sample size is adjusted for the 25% drop out rate, the sample size required is 426 (213 per group).
This study will be the first study that evaluates exercise and smoking cessation among African Americans that could provide a new approach to the management of smoking cessation among this minority population.
Project Narrative
Cigarette smoking continues to be the leading cause of preventable death and disease in the United States, contributing to morbidity and mortality related to heart disease, cancer, and stroke. The Institute of Medicine (IOM) has recognized smoking cessation program development as a top public health priority. Our study plans to address the effectiveness of different methods for smoking cessation for African-Americans, who have higher rates of smoking on average than other races, in order to reduce health disparities in this portion of the population.
Facilities and Equipment
Study visits will take place at the Birmingham Free Clinic, 44 South 9th Street, Pittsburgh, PA 15203; the UPMC Walk-in Primary Care Clinic, 2000 Mary Street, Pittsburgh, PA 15203; the Hosanna House, 807 Wallace Avenue Wilkinsburg, PA 15221; and/or the Hill House, 1835 Centre Avenue, Pittsburgh, PA 15219. All four facilities are located within short distance of public transportation, making them highly accessible to participants.
Birmingham Free Clinic
Birmingham Free clinic is a free, walk-in health clinic in the City of Pittsburgh serving over 2,800 patients annually and is partnered with the Salvation Army. Patient referrals to the clinic come from the Allegheny County Health Department, regional hospital emergency departments, employment agencies, the Department of Public Assistance and from local Federally Qualified Community Health Centers (FQHC). An exclusively volunteer staff of just over 70 physicians, pharmacists, and nurses provide all clinical services. The Birmingham clinic offers primary care free of charge, with no third-party billing.
UPMC Walk-in Primary Care Clinic
The UPMC Mercy South Side Outpatient Center, home of the UPMC Walk-in Primary Care Clinic, provides health care services to patients without an appointment. The clinic is open Monday-Saturday, allowing flexibility for scheduling participant visits. The clinic has ample space for conducting study visits. Hosanna House
Hosanna House, Inc. is a multi-purpose community center serving over 35,000 people a year. The Hosanna House mission is to provide families and individuals with quality health and human services.
Hill House
The Hill House Association delivers a spectrum of integrated social services to its community. Located in the Hill District of Pittsburgh, the Hill House has ample space to accommodate clinic staff for scheduled visits with study participants.
Physical Activity Measurements
For physical activity measurements, Accusplit AE120XL pedometers will be used to collect step counts and the Modifiable Activity Questionnaire (MAQ) will be used to assess past month leisure and occupational physical activity. The MAQ is a valid and reliable assessment tool in adult African American populations (Vuillemin et al., 2000). The Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) assessment, valid and reliable among African American adults, will be used to assess willingness to make changes in physical activity and nutrition behaviors (Taylor et al., 2004). The EuroQol Group EQ-5D-3L will be used to measure health status. The EQ-5D-3L is a valid and reliable tool for assessing health status among African American adults (Rabin & de Charro, 2001). Weight will be measured using Detecto ProDoc PD100 scales.
Withdrawal and Smoking Cessation Validation Measurements
Withdrawal symptoms will be measured with the Minnesota Nicotine Withdrawal Scale. Carbon monoxide measurements and urine tests will be conducted to assess the level of smoking cessation. Smokerlyzer® (Bedfont Scientific Ltd., piCO+™) will be used to measure the carbon monoxide levels. NicAlertTM urine test strips will be used to measure cotinine levels in the urine. With 93% sensitivity and 95% specificity, these test strips are a valid and reliable method to measuring cotinine levels (Cooke, 2008).
Data Management
Data collection and management will be facilitated through the Graduate School of Public Health Epidemiology Data Center (EDC). The EDC has collaborated in over 100 research studies sponsored by the National Institutes of Health and other agencies. The EDC currently hosts data management and analysis activities for 26 research projects. The EDC employs full-time faculty and staff with expertise in data management and statistical analysis.
Biosketches
Name: YYYYY
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Department of Epidemiology
Education/Training:
Institution
Degree
Date Completed
Field of Study University of Pittsburgh
B.S.
December 2008
Biology
Indiana University of PA
M.S.
August 2011
Sports Science
University of Pittsburgh
Ph.D.
In Progress
Epidemiology
A. Personal Statement
For this trial, I will be evaluating the effectiveness of a physical activity intervention at increasing likelihood to quit smoking. During graduate coursework at Indiana University of Pennsylvania, I gained experience in human physiological function testing, body composition analysis, and exercise prescription. My field experience includes cardiac and pulmonary rehabilitation and physical therapy. I have work experience as a personal trainer and fitness instructor. My experience in exercise prescriptive and fitness instruction gives me confidence for developing a sensible and effective activity intervention. As a graduate student at the University of Pittsburgh, I am currently gaining field experience in translational research working on the Group Lifestyle Balance® Translation Project. This project focuses on the evaluation of lifestyle intervention for the prevention of type 2 diabetes delivered in the community. I am involved in participant screening, data collection, and project management. My training in Epidemiology has led to competency in study design and data analysis methods. With a special focus on Physical Activity Epidemiology, I am prepared to evaluate the effectiveness of lifestyle interventions at reducing the risk for chronic disease. I am currently under the advisement of Iva Miljkovic, MD, PhD, Assistant Professor in the Department of Epidemiology.
B. Positions and Honors
2011-Present: Research Assistant, University of Pittsburgh Diabetes Prevention Support Center
Memberships:
2012-Present: American Public Health Association
2010, 2012 American College of Sports Medicine
Name: MMM
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Multidisciplinary Program
Education/Training:
Institution
Degree
Date Completed
Field of Study
Stanley Medical College
M.D.
February 2005
Medicine
University of Pittsburgh
MPH
In Progress
Multidisciplinary
A. Personal Statement
My primary role in this study will be as a clinical expert and also as data analyst. This study focuses on physical activity as an intervention to help and maintain smoking cessation among low income African Americans in Pittsburgh. I volunteer at the Birmingham clinic where we have planned to recruit the subjects. This would help in the subject recruitment phases. My work in the previous projects has familiarized me with the use of SPSS statistical package for data analysis. This experience will be useful in the data entry and the analysis phase of the study. As an internal medicine physician I have been always involved in taking care patients with a history of smoking. I have been specifically interested in smoking cessation counseling which I perform on my day to day clinical practice. My current research is in Crohn’s disease post-operative outcomes. Smoking is strongly associated with poor outcomes and disease recurrence in Crohn’s disease. That has interested me in being a part of clinical trial in smoking cessation.
B. Positions and Honors
2007-2010: Internal Medicine residency, UPMC Mercy
2010-Present: Clinical Instructor in Internal Medicine, UPMC Presbyterian
Memberships:
2008-Present: Member, American College of Physicians
2009-Present: Member, American College of gastroenterology
2010-Present: Member, American Gastroenterology Association
Peer reviewed publications
1: Barrie A, Mourabet ME, Weyant K, Clarke K, Gajendran M, Rivers C, Park SY,
Hartman D, Saul M, Regueiro M, Yadav D, Binion DG. Recurrent Blood Eosinophilia in Ulcerative Colitis Is Associated with Severe Disease and Primary Sclerosing Cholangitis. Dig Dis Sci. 2012 Aug 2.
2: Muniraj T, Gajendran M, Thiruvengadam S, Raghuram K, Rao S, Devaraj P. Acute pancreatitis. Dis Mon. 2012 Mar;58(3):98-144. Review.
3: Gajendran M, Muniraj T, Yassin M. Diverticulitis complicated by pylephlebitis: a case report. J Med Case Rep. 2011 Oct 10;5:514.
4: Gajendran M, Muniraj T, Gelrud A. A challenging case of gastric outlet obstruction (Bouveret 's syndrome): a case report. J Med Case Rep. 2011 Oct 4;5:497.
Name: C
Position/Title: Data Manager, University of Pittsburgh, Department of General Internal Medicine
Education/Training:
Institution
Degree
Date Completed
Field of Study
Xavier University of New Orleans
B.S.
May 2001
Biology
University of Pittsburgh
M.P.H.
May 2003
Epidemiology
A. Personal Statement
The Physical Activity on Smoking cessation (PASC) clinical trial evaluates the effectiveness physical activity, nutritional counseling and nicotine replacement therapy (NRT) + counseling as compared to NRT + counseling among low-income African Americans. My roles on this trial are co-investigator and data manager. My role of data manager is supported by my vast experience with creating and managing databases, designing questionnaires, and creating complex reports and datasets. My knowledge of programming and statistical software packages further lends itself to this role. For the past five years, I have been researching smoking cessation in low income populations. Most recently, I have been conducting research that examines patterns and determinants to adherence in among low-income veterans. This experience has prepared me to design and conduct this trial.
B. Positions and Honors
Professional Positions
2000-2003 Research Associate, Louisiana State University, HIV Outpatient Program
2001- 2003 Epidemiology Research Intern, Tulane University School of Public Health and
Tropical Medicine, Department of Epidemiology
2003-2005 Research Program Manager, Ochsner Clinic Foundation, Department of Endocrine
2006-2007 Contracted Part-time Epidemiologist, Birth Circle, Grass-Roots Organization
2006-2007 Research Assistant, University of Pittsburgh, Graduate School of Public Health
2007-2008 Research Assistant, University of Pittsburgh, Western Psychiatric Institute and Clinic
2008 - 2011 Research Associate, University of Pittsburgh, Department of Psychology
2011 – present Research Associate, University of Pittsburgh, Department of General Internal Medicine
Awards and Honors
1998 Tri-Beta (Biological Honor Society)
Peer reviewed publications
Theall, Katherine; Mitchell, Chantele; Ludwig, Maria; Brown, Barbara; Kissinger, Patricia. (2004) Factors Associated with Maternal-Child Separation Among HIV Infected Mothers. AIDS Patient Care and STDs, 9 509-519.
Shiffman, Saul; Tindle, Hilary; Scholl, Sarah; Dunbar, Michael; Mitchell-Miland, Chantele. (2012) Characteristics and smoking patterns of intermittent smokers. Experimental and Clinical Psychopharmacology 20 (4): 264.277.
Name: I
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Multidisciplinary Program
Education/Training:
Institution
Degree
Date Completed
Field of Study
Universidad Nacional Mayor de San Marcos
M.D.
June 2004
Medicine
University of Pittsburgh
M.P.H.
In Progress
Multidisciplinary
A. Personal statement
My primary role in this study will be as a clinical expert and also as data analyst. As a physician I have worked as primary care provider and in programs that aim to reduce blindness due to cataract and diabetic retinopathy. I have a long standing interest in minority health and the eliminations of health disparities. Smoking is a huge public health problem especially among minorities; this project focus in African Americans is a great opportunity to learn more about this. My knowledge and interest will drive my involvement in this study.
B. Positions and Honors
2001-2004: Ophthalmology residency, Maria Auxiliadora Hospital
2004-2008: Attending physician Solidaridad Hospital
2011- present: Research assistant at the university of Pittsburgh Department of Family Medicine, Center for Primary Care Community-Based Research
Memberships:
2001-Present: Member, Peruvian College of Physicians
2004-Present: Member, Peruvian Ophthalmology society
Publications
Poster Presentation
• Folio L.,, Wollstein.G, Serrano I., Ishikawa I. , Noecke R., Fujimoto J., Schuman J.
(2009, May). Detection of Glaucoma Progression with Optical Coherence Tomography and Scanning Laser Polarimetry. Poster presented at: ARVO 2009; Fort Lauderdale, FL.
Serrano ,I ., Alvarez, J., Hernandez M. MD.. (2002, July). Prevalence of Demodex folliculorum in patients with diagnosis of Blepharitis,. Poster presented at: Peruvian Society of Ophthalmology XIX Peruvian Congress of Ophthalmology; Lima, Peru.
Weir,R.,Serrano I.. (2011, July). Blindness due to Diabetic Retinopathy in Allegheny County..Poster presented at: Poster presented at: Graduate School of Public Health,
University of Pittsburgh; Pittsburgh, PA.; Pittsburgh, PA.
Non Peer Reviewed Online Publication
Serrano I, Waxman E.. (2012, February 13). Diabetic Retinopathy. http://www.pitt.edu/~super7/46011-47001/46191.ppt. Serrano I.,Waxman E.. (2011, June 1). Blindness, June 2011... http://www.pitt.edu/~super1/lecture/lec42271/index.htm..
Serrano I.,Waxman E... (2011, September 9). Blindness(Spanish version).. http://www.pitt.edu/~super1/lecture/lec42831/index.htm
Name: D
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Department of Epidemiology
Education/Training:
Institution
Degree
Date Completed
Field of Study University of Pittsburgh B.S.
May 2011
Mathematics
University of Pittsburgh
M.P.H.
May 2013
Epidemiology
A. Personal Statement
Given my undergraduate training in mathematics and my graduate training in biostatistics, I have developed strong quantitative skills, and therefore, will serve as the statistician for this clinical trial.
Through my graduate work on the Long Life Family Study at the Health Studies Research Center, I have gained valuable experience in collecting and managing data. I am confident that my refined skills in data collection and management will allow me to effectively assist in this trial as a co-investigator and a co-data manager. I am prepared to use my background as a means to effectively collect and analyze data throughout the course of this study to provide beneficial results which can be generalized to this minority population.
B. Positions and Honors
May 2012-present: Long Life Family Study research staff member
Specific Aims
The Institute of Medicine (IOM) has recognized smoking cessation program development as a top public health priority. Studies have found effectiveness for smoking cessation in behavioral strategies, including cigarette smoking cessation therapy or physical activity (Haasova et al., 2012). However, not much is known about these therapies used simultaneously (Ussher et al., 2012; Farley et al., 2012) or how effective these therapies are in African American populations. The African-American population was selected for this study based on previous research that African-Americans in Allegheny County have a higher prevalence of being a smoker, compared to their White counterparts, and experience higher rates of obesity, heart disease, cancer and stroke as compared to their White counterparts (Allegheny Report, April 2011). These conditions are often caused or worsened by cigarette smoking (USDHHS, 2004). Subsequently, African-Americans in Allegheny County have higher rates of poverty and unemployment, have a higher prevalence of co-morbidities, and have lower rates of health care coverage (Prapavessis et al., 2007) which are all significant barriers to smoking cessation. A recently published article by Berg et al. (2012) provides evidence that interventions targeting multiple risk factors can be effective to increase healthy living and the cessation of cigarette smoking. Among the African-American population in Allegheny County, smoking cessation programs including physical activity and nutritional counseling have not been studied. We are proposing an intervention using combination nicotine replacement therapy (NRT), smoking cessation and nutritional counseling, and physical activity and comparing the effectiveness to NRT and smoking cessation counseling alone in the standard treatment (ST) group.
Aim1. To evaluate the effectiveness of physical activity and nutritional counseling (PASC) combined with standard treatment compared to standard treatment alone for smoking cessation among low-income African American smokers (100 cigarettes in lifetime and daily use for past 30 days)
> 18 years old
Low socioeconomic status (< $35,000 per annum per household of four)
BMI > 24
Willing to quit smoking
Resident of Allegheny County, Pennsylvania
Research participants will be excluded and considered in-eligible for the study if they meet any of the following criteria:
Exclusion Criteria:
Generalized chronic dermatological disorders, such as psoriasis, chronic dermatitis, or urticaria
Patients with known hypersensitivity to nicotine or any components of the patch
Recent myocardial infarction (within last 6 months)
Unstable or progressive angina pectoris
Cardiac arrhythmias
Acute phase stroke (within last 6 months)
Pregnant or breast feeding women
Musculoskeletal problems preventing brisk walking
Moderate to severe COPD
Medical condition in which regular, moderate physical activity is contraindicated by physician
Treatments
Participants will be randomized to either receive nicotine replacement therapy (NRT) and smoking cessation counseling or NRT, smoking cessation and nutritional counseling, and a physical activity intervention. Standard treatment consists of NRT and smoking cessation counseling while the intervention will consist of the addition of nutritional counseling, and physical activity.
Standard Treatment (ST)
Both groups will receive standard treatment. Within standard treatment, participants will be advised to use combination NRT therapy (patch and gum/lozenge), however participants will be given the ability to choose single NRT, especially if participants experience problems with any of the NRT, such as rashes resulting from patch use. Participants will also receive individual smoking cessation counseling sessions which will include instruction on the appropriate use of NRT, education on dealing with withdrawal symptoms, triggers and other barriers to quitting, relapses, and the short/long term effects of cigarette smoking on their health, and assistance with setting appropriate goals and time period for a quit date. Smoking cessation counseling sessions will be tailored, as needed, to provide support for the quitting stage and/or progress of the smoker. The initial smoking cessation counseling session will take place between 1-2 weeks following the baseline and randomization visit. Within the first month following randomization, participants will be asked to complete at least two in-person smoking cessation sessions, but will have the option to complete up to four study visits. Participants will be asked to set a quit date within one month following randomization. During months two and three, participants will be asked to complete biweekly study visits. For months four through twelve participants will complete monthly visits. Phone counseling will be available for participants who are unable or prefer not to attend counseling at the clinic and in person. In addition, a 24-hour quit line will be made available for participants who need more support for quitting smoking. On a monthly basis, the participants will come to the clinic and complete carbon monoxide (CO) test via Smokerlyzer® and cotinine urine tests by providing a urine sample to monitor their smoking cessation progress. Measurements will coincide with their counseling visits. In addition, participants will receive two pamphlets at baseline; one outlining healthy nutritional guidelines and one outlining physical activity guidelines for adults. At baseline, participants will complete the EQ-5D-3L to assess health status, the Modifiable Activity Questionnaire (MAQ) to assess past month leisure-time and occupational physical activity, and the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) assessment to assess willingness to make changes in physical activity and nutrition behaviors (Taylor et al, 2004). At 3 months, 6 months, and 1 year, participants will complete the PACE activity willingness questionnaire, the Modifiable Activity Questionnaire (MAQ), the EQ-5D-3L to assess perception of health, and the Minnesota Nicotine Withdrawal Scale to assess withdrawal symptoms.
Physical Activity and Nutrition Intervention
Participants randomized to the PASC arm will receive individual physical activity and group-based nutritional counseling in addition to standard treatment. Participants will receive instruction at baseline on how to wear a pedometer correctly and be asked to wear it and record steps for one week and will be assessed at their first smoking cessation visit. Participants will then return for their second smoking cessation session for a one-hour session on the guidelines for physical activity for adults (10,000 steps per day, 150 minutes of moderate physical activity per week, or 30 minutes 5 days per week) and how to monitor their physical activity and set goals. Participants will receive follow-up phone calls each week to collect step counts and weekly activity minutes and discuss weekly goal setting for physical activity. Weekly follow-up calls will occur throughout the first 3 months (12 weeks) of the study. Monthly evaluation of physical activity goals will occur during monthly counseling appointments. At 3 months, 6 months, and 1 year, PASC arm participants will be asked to report step counts for one (1) week prior to their assessment visit. In addition to physical activity intervention, PASC participants will receive three (3) one-hour group nutrition counseling sessions delivered at start of intervention, 3 months, and 6 months. The nutrition counseling will be delivered in group sessions by a licensed dietician. Materials distributed during the first counseling session will include suggested meal plans for calorie reduction (1200, 1500, and 1800 calories), information on portion sizes, information on essential vitamins and minerals, and guidelines for fat gram intake goals. The second group nutrition session at 3 months will include information on dining out, mindful eating, and a re-emphasis on portion sizes and food selection. The third group nutrition session at 6 months will include trouble-shooting, sports-nutrition counseling, and evaluation of eating habits. At each time point (baseline, 3 months, 6 months), multiple sessions will be offered spanning multiple weekdays and times of day (morning, noon, evening).
Outcomes
Physical activity levels and smoking cessation will be measured during the study using various tools. Physical activity level will be assessed by measuring the number of steps taken daily by the participant using Accusplit AE120XL pedometers. The number of steps will be measured and reported on a weekly basis for the first twelve (12) weeks of the intervention. After the first 12 weeks, physical activity level will be assessed every three months using the Modifiable Activity Questionnaire (MAQ), which assesses the participant’s leisure and occupational activity in the past month, and by reporting steps for the prior 7-days. Participant’s activity level will be able to be evaluated over time, comparing the results to his/her baseline data. Willingness to change behaviors related to physical activity and nutrition will be measured via the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) at baseline, 3 months, 6 months, and 12 months. The EuroQol Group EQ-5D-3L will be used to measure perceived health status at baseline, 3 months, 6 months, and 12 months. Smoking cessation will be assessed weekly for the first month by measuring carbon monoxide levels and levels of cotinine in the urine. Carbon monoxide values will be collected using Smokerlyzer® (Bedfont Scientific Ltd., piCO+™). NicAlertTM urine test strips will be used to measure cotinine levels in the urine. Withdrawal symptoms will also be measured weekly for the first month, using the Minnesota Nicotine Withdrawal Scale; inquiring about daily use of nicotine, symptoms following the stop or reduction of nicotine use, as well as impact of daily functioning, while monitoring for symptoms due to a general medical or mental condition. These measures will be collected bi-weekly from baseline until the end of month 2 (eight weeks). Then, measurement collection will happen monthly until the conclusion of the trial at month 12. Measurement collection will occur during one-on-one counseling sessions with the clinic expert.
Additionally, weight loss will be assessed as a percent weight loss from weight at baseline. Weight will be measured on a weekly basis for the first 12 weeks and then monthly up to 12 months using the Detecto ProDoc PD100 scale.
Sample Size Calculation
We used the study by Prapavessis et al. as a guide to estimate the sample size (2007). The investigators studied differences in 4 different groups (1) exercise + nicotine patch (2) exercise + no nicotine patch (3) cognitive behavior therapy (CBT) + nicotine patch and (4) cognitive behavior therapy + no nicotine patch. The 12 month cessation rates were 15 % for the CBT + patch group and 27% for the exercise + patch group. We used University of Iowa website (http://homepage.cs.uiowa.edu/~rlenth/Power/) for the calculation of sample size. “Test comparing two proportions” was selected for analysis. We choose 15% as the cessation rate for the standard treatment group (Nicotine replacement therapy + counseling) and 30 % for the treatment group (Physical activity + Nicotine replacement therapy + counseling) to detect a between group difference of 15 percentage points or a 50% increase in cessation success. Alpha was set at 0.025 to allow for multiple comparisons. We calculated sample size requirements for 80% power. This resulted in a total sample size of 320 (160 in each group). Results of an array of power calculations are summarized in Table 1. We expect a 75% retention rate based on the study by Steinberg et al (2009). When the sample size is adjusted for the 25% drop out rate, the sample size required is 426 (213 per group).
Table 1. Sample Size for Test Comparing Two Proportions (Smoking Cessation)
Treatment group
Control group
Power
Sample size
Sample size adjusted for 75% retention
15%
25%
80
646 (323 in each group)
861
15%
25%
90
830 (415 In each group)
1106
15%
30%
80
320 (160 in each group)
426
15%
30%
90
408 (204 in each group)
544
Weight loss will be reported as a percentage of initial body weight reduction.
The outcome will be continuous. Aligning with the goals of the intervention, the PASC arm is anticipated to have a 5% weight loss at 6 months of follow-up. The comparator arm is anticipated to have no weight loss or potential weight gain. Using estimates of mean weight loss of 0% for the comparator arm and 5% weight loss in the PASC arm and a range of estimates for standard deviation (0.5x the mean, equal to the mean, and 1.5x the mean), we calculated sample size requirements for 80% and 90% power using SAS 9.3 procedure for difference between means with alpha set at 0.025 to allow for multiple comparisons. The resulting sample sizes are summarized in Table 2. We have selected the most conservative estimate for sample size as our target for recruitment. Adjusted for the 75% retention rate, our target sample size for 80% power, alpha level of 0.025 is 120 (60 per
group).
Table 2. Sample Size for Test of Mean Difference (Weight Loss)
Treatment group
Control group
Standard Deviation
Power
Sample size
Sample size adjusted for 75% retention
5%
0%
2.5
80
14 (7 in each group)
20
5%
0%
2.5
90
16 (8 in each group)
22
5%
0%
5.0
80
42 (21 in each group)
56
5%
0%
5.0
90
54 (27 in each group)
72
5%
0%
7.5
80
90 (45 in each group)
120
5%
0%
7.5
90
116 (58 in each group)
156
For this study, we will recruit based on the sample size needed to detect a difference in smoking cessation rates of 15% between groups, with a 50% increase in cessation success in the treatment arm. Therefore, our target enrollment is 426 participants, 213 for each intervention arm.
Analysis Plan
For variables presented in Table 3, independent samples t-tests for continuous variables and χ2 test for categorical variables at alpha level of 0.05 will be conducted to assess differences in characteristics between treatment group and active comparator at time of randomization (baseline). Significant differences in groups will be defined as mean differences with an associated p-value 1 pack/day, 1 year, 7d/w
Previous attempts to quit
Dichotomous
Yes/No
We will use intention-to-treat analysis to conduct all primary statistical analysis. Before using statistical analysis for comparison of outcomes between treatment groups, box plots for continuous variables and proportions for dichotomous variables will be compared to visually detect differences. Exploratory data analysis using graphical methods will be used to determine the type of variable to use for the predictors cigarettes, household income, duration of smoking, and alcohol use. Box plots, quartiles, interquartile ranges, and frequency distributions will be used to determine categorical cut-points. Additionally, exploratory data analysis for differences in cessation rates and weight loss by gender will be conducted by using graphical analysis.
The primary outcomes of the study are smoking cessation rates, withdrawal symptoms, weight loss, duration of abstinence and quality of life. Smoking cessation is a categorical variable and will perform a chi-square test of two proportions (χ ²) to compare cessation rates between groups. Other primary outcomes are measured as continuous variables and an independent two sample t-test will be performed to compare the means of the two groups. An alpha of 0.025 will be used to determine statistically significant differences.
After conducting independent samples t-tests and chi-square test of two proportions for primary outcomes to see if there is a statistically significant difference between the mean values of treatment groups, appropriate regression models for each outcome will be run to include any possible predictors and confounders, and to determine if the differences between treatment groups remain.
First, univariate analysis for the predictors (treatment group, duration of smoking, cigarettes, age, sex, alcohol use, BMI, income, and previous attempts to quit) will be run to determine independent effects on the outcomes (smoking cessation, weight loss, time of abstinence, withdrawal symptoms, quality of life, and stage of willingness to make lifestyle changes). Predictors with a Wald test statistic with a p-value of < 0.10 will be kept in the multivariate models.
To determine factors associated with smoking cessation, defined as 0=no and 1=yes, logistic regression for treatment group on smoking cessation will be used to calculate an odds ratio, adjusted for independence from predictors. Treatment group will be considered an independent predictor of smoking cessation if the Wald test with a Chi-square distribution yields a p-value
Group 3
Table of Contents
Project Abstract……………………………………………………………………………..… 3
Project Narrative…………………………………………………………………………….… 4
Facilities/Equipment………………………………………………………………………..… 5
Biosketches……………………………………………………………………………………. 6
Specific Aims…………………………………………………………………………….…... 11
Research Plan………………………………………………………………………………… 12 Background and Significance………………………………………………..….… 12 Approach…………………………………………………………………………….. 14 Hypothesis………………………………………………………………….. 14 Design and Randomization……………………………………………….. 14 Recruitment…..................................................................................... 14 …show more content…
Inclusion/Exclusion…………………………………………………..…... 15 Treatments…...................................................................................... 15 Outcomes…………………………………………………………………... 16 Sample Size………………………………………………………………... 17 Analysis………………………………………………………………….…. 18 Investigators and Environment………………………………………………….... 21 Timeline and Milestones…………………………………………………..………. 22
References…………………………………………………………………………..……..… 23
Human Subjects Protection………………………………………………………...……... 26
Appendices………………………………………………………………………………….. 31 Recruitment Plan……………………………………………………………..……. 31 Consent Form……………………………………………………………….….….. 32 Data Management………………………………………………………………..... 37 Randomization Pattern…………………………………………………………….. 38
Project Abstract
Smoking is the leading cause of preventable death in the United States, accounting for approximately 443,000 deaths, or 1 of every 5 deaths, each year. In fact 50% of smokers will die from smoking related causes. National statistics showed that African Americans have one of the highest prevalence of cigarette smoking (20.6%) after white non-Hispanics (21%). According to the CDC, African Americans represented the second highest proportion of cigarette smokers (28.7%) in Allegheny County. Many studies have shown that exercise decreases smoking withdrawal symptoms, but it is unclear if exercise could have similar results among African Americans.
We will examine the addition of physical activity and nutritional counseling to the standard treatment for smoking cessation among low-income African Americans in Allegheny County.
Our hypothesis is that low-income African American smokers, randomized to participate in the physical activity intervention arm, will have higher rates of smoking cessation, significant weight loss, less withdrawal symptoms and longer periods of abstinence after one year.
The proposed study will be a prospective randomized controlled trial. We will use a parallel design with two treatment arms and will follow participants for 12 months. Both arms will receive the standard treatment (nicotine replacement therapy and smoking cessation counseling). In addition, the intervention arm will include physical activity and nutrition counseling. We will request the participants to engage in moderate physical activity for 150 minutes per week and we will collect the number of steps counts and weekly activity …show more content…
minutes.
Willingness to change behaviors related to physical activity and nutrition will be measured via the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE). The EuroQol Group EQ-5D-3L will be used to measure their perceived health status. Smoking cessation will be assessed by measuring carbon monoxide levels and levels of cotinine in the urine. Withdrawal symptoms will also be measured using the Minnesota Nicotine Withdrawal Scale. Additionally, weight loss will be assessed as a percent weight loss from weight at baseline. In our sample size we expect a 75% retention rate, when the sample size is adjusted for the 25% drop out rate, the sample size required is 426 (213 per group).
This study will be the first study that evaluates exercise and smoking cessation among African Americans that could provide a new approach to the management of smoking cessation among this minority population.
Project Narrative
Cigarette smoking continues to be the leading cause of preventable death and disease in the United States, contributing to morbidity and mortality related to heart disease, cancer, and stroke. The Institute of Medicine (IOM) has recognized smoking cessation program development as a top public health priority. Our study plans to address the effectiveness of different methods for smoking cessation for African-Americans, who have higher rates of smoking on average than other races, in order to reduce health disparities in this portion of the population.
Facilities and Equipment
Study visits will take place at the Birmingham Free Clinic, 44 South 9th Street, Pittsburgh, PA 15203; the UPMC Walk-in Primary Care Clinic, 2000 Mary Street, Pittsburgh, PA 15203; the Hosanna House, 807 Wallace Avenue Wilkinsburg, PA 15221; and/or the Hill House, 1835 Centre Avenue, Pittsburgh, PA 15219. All four facilities are located within short distance of public transportation, making them highly accessible to participants.
Birmingham Free Clinic
Birmingham Free clinic is a free, walk-in health clinic in the City of Pittsburgh serving over 2,800 patients annually and is partnered with the Salvation Army. Patient referrals to the clinic come from the Allegheny County Health Department, regional hospital emergency departments, employment agencies, the Department of Public Assistance and from local Federally Qualified Community Health Centers (FQHC). An exclusively volunteer staff of just over 70 physicians, pharmacists, and nurses provide all clinical services. The Birmingham clinic offers primary care free of charge, with no third-party billing.
UPMC Walk-in Primary Care Clinic
The UPMC Mercy South Side Outpatient Center, home of the UPMC Walk-in Primary Care Clinic, provides health care services to patients without an appointment. The clinic is open Monday-Saturday, allowing flexibility for scheduling participant visits. The clinic has ample space for conducting study visits. Hosanna House
Hosanna House, Inc. is a multi-purpose community center serving over 35,000 people a year. The Hosanna House mission is to provide families and individuals with quality health and human services.
Hill House
The Hill House Association delivers a spectrum of integrated social services to its community. Located in the Hill District of Pittsburgh, the Hill House has ample space to accommodate clinic staff for scheduled visits with study participants.
Physical Activity Measurements
For physical activity measurements, Accusplit AE120XL pedometers will be used to collect step counts and the Modifiable Activity Questionnaire (MAQ) will be used to assess past month leisure and occupational physical activity. The MAQ is a valid and reliable assessment tool in adult African American populations (Vuillemin et al., 2000). The Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) assessment, valid and reliable among African American adults, will be used to assess willingness to make changes in physical activity and nutrition behaviors (Taylor et al., 2004). The EuroQol Group EQ-5D-3L will be used to measure health status. The EQ-5D-3L is a valid and reliable tool for assessing health status among African American adults (Rabin & de Charro, 2001). Weight will be measured using Detecto ProDoc PD100 scales.
Withdrawal and Smoking Cessation Validation Measurements
Withdrawal symptoms will be measured with the Minnesota Nicotine Withdrawal Scale. Carbon monoxide measurements and urine tests will be conducted to assess the level of smoking cessation. Smokerlyzer® (Bedfont Scientific Ltd., piCO+™) will be used to measure the carbon monoxide levels. NicAlertTM urine test strips will be used to measure cotinine levels in the urine. With 93% sensitivity and 95% specificity, these test strips are a valid and reliable method to measuring cotinine levels (Cooke, 2008).
Data Management
Data collection and management will be facilitated through the Graduate School of Public Health Epidemiology Data Center (EDC). The EDC has collaborated in over 100 research studies sponsored by the National Institutes of Health and other agencies. The EDC currently hosts data management and analysis activities for 26 research projects. The EDC employs full-time faculty and staff with expertise in data management and statistical analysis.
Biosketches
Name: YYYYY
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Department of Epidemiology
Education/Training:
Institution
Degree
Date Completed
Field of Study University of Pittsburgh
B.S.
December 2008
Biology
Indiana University of PA
M.S.
August 2011
Sports Science
University of Pittsburgh
Ph.D.
In Progress
Epidemiology
A. Personal Statement
For this trial, I will be evaluating the effectiveness of a physical activity intervention at increasing likelihood to quit smoking. During graduate coursework at Indiana University of Pennsylvania, I gained experience in human physiological function testing, body composition analysis, and exercise prescription. My field experience includes cardiac and pulmonary rehabilitation and physical therapy. I have work experience as a personal trainer and fitness instructor. My experience in exercise prescriptive and fitness instruction gives me confidence for developing a sensible and effective activity intervention. As a graduate student at the University of Pittsburgh, I am currently gaining field experience in translational research working on the Group Lifestyle Balance® Translation Project. This project focuses on the evaluation of lifestyle intervention for the prevention of type 2 diabetes delivered in the community. I am involved in participant screening, data collection, and project management. My training in Epidemiology has led to competency in study design and data analysis methods. With a special focus on Physical Activity Epidemiology, I am prepared to evaluate the effectiveness of lifestyle interventions at reducing the risk for chronic disease. I am currently under the advisement of Iva Miljkovic, MD, PhD, Assistant Professor in the Department of Epidemiology.
B. Positions and Honors
2011-Present: Research Assistant, University of Pittsburgh Diabetes Prevention Support Center
Memberships:
2012-Present: American Public Health Association
2010, 2012 American College of Sports Medicine
Name: MMM
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Multidisciplinary Program
Education/Training:
Institution
Degree
Date Completed
Field of Study
Stanley Medical College
M.D.
February 2005
Medicine
University of Pittsburgh
MPH
In Progress
Multidisciplinary
A. Personal Statement
My primary role in this study will be as a clinical expert and also as data analyst. This study focuses on physical activity as an intervention to help and maintain smoking cessation among low income African Americans in Pittsburgh. I volunteer at the Birmingham clinic where we have planned to recruit the subjects. This would help in the subject recruitment phases. My work in the previous projects has familiarized me with the use of SPSS statistical package for data analysis. This experience will be useful in the data entry and the analysis phase of the study. As an internal medicine physician I have been always involved in taking care patients with a history of smoking. I have been specifically interested in smoking cessation counseling which I perform on my day to day clinical practice. My current research is in Crohn’s disease post-operative outcomes. Smoking is strongly associated with poor outcomes and disease recurrence in Crohn’s disease. That has interested me in being a part of clinical trial in smoking cessation.
B. Positions and Honors
2007-2010: Internal Medicine residency, UPMC Mercy
2010-Present: Clinical Instructor in Internal Medicine, UPMC Presbyterian
Memberships:
2008-Present: Member, American College of Physicians
2009-Present: Member, American College of gastroenterology
2010-Present: Member, American Gastroenterology Association
Peer reviewed publications
1: Barrie A, Mourabet ME, Weyant K, Clarke K, Gajendran M, Rivers C, Park SY,
Hartman D, Saul M, Regueiro M, Yadav D, Binion DG. Recurrent Blood Eosinophilia in Ulcerative Colitis Is Associated with Severe Disease and Primary Sclerosing Cholangitis. Dig Dis Sci. 2012 Aug 2.
2: Muniraj T, Gajendran M, Thiruvengadam S, Raghuram K, Rao S, Devaraj P. Acute pancreatitis. Dis Mon. 2012 Mar;58(3):98-144. Review.
3: Gajendran M, Muniraj T, Yassin M. Diverticulitis complicated by pylephlebitis: a case report. J Med Case Rep. 2011 Oct 10;5:514.
4: Gajendran M, Muniraj T, Gelrud A. A challenging case of gastric outlet obstruction (Bouveret 's syndrome): a case report. J Med Case Rep. 2011 Oct 4;5:497.
Name: C
Position/Title: Data Manager, University of Pittsburgh, Department of General Internal Medicine
Education/Training:
Institution
Degree
Date Completed
Field of Study
Xavier University of New Orleans
B.S.
May 2001
Biology
University of Pittsburgh
M.P.H.
May 2003
Epidemiology
A. Personal Statement
The Physical Activity on Smoking cessation (PASC) clinical trial evaluates the effectiveness physical activity, nutritional counseling and nicotine replacement therapy (NRT) + counseling as compared to NRT + counseling among low-income African Americans. My roles on this trial are co-investigator and data manager. My role of data manager is supported by my vast experience with creating and managing databases, designing questionnaires, and creating complex reports and datasets. My knowledge of programming and statistical software packages further lends itself to this role. For the past five years, I have been researching smoking cessation in low income populations. Most recently, I have been conducting research that examines patterns and determinants to adherence in among low-income veterans. This experience has prepared me to design and conduct this trial.
B. Positions and Honors
Professional Positions
2000-2003 Research Associate, Louisiana State University, HIV Outpatient Program
2001- 2003 Epidemiology Research Intern, Tulane University School of Public Health and
Tropical Medicine, Department of Epidemiology
2003-2005 Research Program Manager, Ochsner Clinic Foundation, Department of Endocrine
2006-2007 Contracted Part-time Epidemiologist, Birth Circle, Grass-Roots Organization
2006-2007 Research Assistant, University of Pittsburgh, Graduate School of Public Health
2007-2008 Research Assistant, University of Pittsburgh, Western Psychiatric Institute and Clinic
2008 - 2011 Research Associate, University of Pittsburgh, Department of Psychology
2011 – present Research Associate, University of Pittsburgh, Department of General Internal Medicine
Awards and Honors
1998 Tri-Beta (Biological Honor Society)
Peer reviewed publications
Theall, Katherine; Mitchell, Chantele; Ludwig, Maria; Brown, Barbara; Kissinger, Patricia. (2004) Factors Associated with Maternal-Child Separation Among HIV Infected Mothers. AIDS Patient Care and STDs, 9 509-519.
Shiffman, Saul; Tindle, Hilary; Scholl, Sarah; Dunbar, Michael; Mitchell-Miland, Chantele. (2012) Characteristics and smoking patterns of intermittent smokers. Experimental and Clinical Psychopharmacology 20 (4): 264.277.
Name: I
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Multidisciplinary Program
Education/Training:
Institution
Degree
Date Completed
Field of Study
Universidad Nacional Mayor de San Marcos
M.D.
June 2004
Medicine
University of Pittsburgh
M.P.H.
In Progress
Multidisciplinary
A. Personal statement
My primary role in this study will be as a clinical expert and also as data analyst. As a physician I have worked as primary care provider and in programs that aim to reduce blindness due to cataract and diabetic retinopathy. I have a long standing interest in minority health and the eliminations of health disparities. Smoking is a huge public health problem especially among minorities; this project focus in African Americans is a great opportunity to learn more about this. My knowledge and interest will drive my involvement in this study.
B. Positions and Honors
2001-2004: Ophthalmology residency, Maria Auxiliadora Hospital
2004-2008: Attending physician Solidaridad Hospital
2011- present: Research assistant at the university of Pittsburgh Department of Family Medicine, Center for Primary Care Community-Based Research
Memberships:
2001-Present: Member, Peruvian College of Physicians
2004-Present: Member, Peruvian Ophthalmology society
Publications
Poster Presentation
• Folio L.,, Wollstein.G, Serrano I., Ishikawa I. , Noecke R., Fujimoto J., Schuman J.
(2009, May). Detection of Glaucoma Progression with Optical Coherence Tomography and Scanning Laser Polarimetry. Poster presented at: ARVO 2009; Fort Lauderdale, FL.
Serrano ,I ., Alvarez, J., Hernandez M. MD.. (2002, July). Prevalence of Demodex folliculorum in patients with diagnosis of Blepharitis,. Poster presented at: Peruvian Society of Ophthalmology XIX Peruvian Congress of Ophthalmology; Lima, Peru.
Weir,R.,Serrano I.. (2011, July). Blindness due to Diabetic Retinopathy in Allegheny County..Poster presented at: Poster presented at: Graduate School of Public Health,
University of Pittsburgh; Pittsburgh, PA.; Pittsburgh, PA.
Non Peer Reviewed Online Publication
Serrano I, Waxman E.. (2012, February 13). Diabetic Retinopathy. http://www.pitt.edu/~super7/46011-47001/46191.ppt. Serrano I.,Waxman E.. (2011, June 1). Blindness, June 2011... http://www.pitt.edu/~super1/lecture/lec42271/index.htm..
Serrano I.,Waxman E... (2011, September 9). Blindness(Spanish version).. http://www.pitt.edu/~super1/lecture/lec42831/index.htm
Name: D
Position/Title: Graduate Student, University of Pittsburgh Graduate School of Public Health, Department of Epidemiology
Education/Training:
Institution
Degree
Date Completed
Field of Study University of Pittsburgh B.S.
May 2011
Mathematics
University of Pittsburgh
M.P.H.
May 2013
Epidemiology
A. Personal Statement
Given my undergraduate training in mathematics and my graduate training in biostatistics, I have developed strong quantitative skills, and therefore, will serve as the statistician for this clinical trial.
Through my graduate work on the Long Life Family Study at the Health Studies Research Center, I have gained valuable experience in collecting and managing data. I am confident that my refined skills in data collection and management will allow me to effectively assist in this trial as a co-investigator and a co-data manager. I am prepared to use my background as a means to effectively collect and analyze data throughout the course of this study to provide beneficial results which can be generalized to this minority population.
B. Positions and Honors
May 2012-present: Long Life Family Study research staff member
Specific Aims
The Institute of Medicine (IOM) has recognized smoking cessation program development as a top public health priority. Studies have found effectiveness for smoking cessation in behavioral strategies, including cigarette smoking cessation therapy or physical activity (Haasova et al., 2012). However, not much is known about these therapies used simultaneously (Ussher et al., 2012; Farley et al., 2012) or how effective these therapies are in African American populations. The African-American population was selected for this study based on previous research that African-Americans in Allegheny County have a higher prevalence of being a smoker, compared to their White counterparts, and experience higher rates of obesity, heart disease, cancer and stroke as compared to their White counterparts (Allegheny Report, April 2011). These conditions are often caused or worsened by cigarette smoking (USDHHS, 2004). Subsequently, African-Americans in Allegheny County have higher rates of poverty and unemployment, have a higher prevalence of co-morbidities, and have lower rates of health care coverage (Prapavessis et al., 2007) which are all significant barriers to smoking cessation. A recently published article by Berg et al. (2012) provides evidence that interventions targeting multiple risk factors can be effective to increase healthy living and the cessation of cigarette smoking. Among the African-American population in Allegheny County, smoking cessation programs including physical activity and nutritional counseling have not been studied. We are proposing an intervention using combination nicotine replacement therapy (NRT), smoking cessation and nutritional counseling, and physical activity and comparing the effectiveness to NRT and smoking cessation counseling alone in the standard treatment (ST) group.
Aim1. To evaluate the effectiveness of physical activity and nutritional counseling (PASC) combined with standard treatment compared to standard treatment alone for smoking cessation among low-income African American smokers (100 cigarettes in lifetime and daily use for past 30 days)
> 18 years old
Low socioeconomic status (< $35,000 per annum per household of four)
BMI > 24
Willing to quit smoking
Resident of Allegheny County, Pennsylvania
Research participants will be excluded and considered in-eligible for the study if they meet any of the following criteria:
Exclusion Criteria:
Generalized chronic dermatological disorders, such as psoriasis, chronic dermatitis, or urticaria
Patients with known hypersensitivity to nicotine or any components of the patch
Recent myocardial infarction (within last 6 months)
Unstable or progressive angina pectoris
Cardiac arrhythmias
Acute phase stroke (within last 6 months)
Pregnant or breast feeding women
Musculoskeletal problems preventing brisk walking
Moderate to severe COPD
Medical condition in which regular, moderate physical activity is contraindicated by physician
Treatments
Participants will be randomized to either receive nicotine replacement therapy (NRT) and smoking cessation counseling or NRT, smoking cessation and nutritional counseling, and a physical activity intervention. Standard treatment consists of NRT and smoking cessation counseling while the intervention will consist of the addition of nutritional counseling, and physical activity.
Standard Treatment (ST)
Both groups will receive standard treatment. Within standard treatment, participants will be advised to use combination NRT therapy (patch and gum/lozenge), however participants will be given the ability to choose single NRT, especially if participants experience problems with any of the NRT, such as rashes resulting from patch use. Participants will also receive individual smoking cessation counseling sessions which will include instruction on the appropriate use of NRT, education on dealing with withdrawal symptoms, triggers and other barriers to quitting, relapses, and the short/long term effects of cigarette smoking on their health, and assistance with setting appropriate goals and time period for a quit date. Smoking cessation counseling sessions will be tailored, as needed, to provide support for the quitting stage and/or progress of the smoker. The initial smoking cessation counseling session will take place between 1-2 weeks following the baseline and randomization visit. Within the first month following randomization, participants will be asked to complete at least two in-person smoking cessation sessions, but will have the option to complete up to four study visits. Participants will be asked to set a quit date within one month following randomization. During months two and three, participants will be asked to complete biweekly study visits. For months four through twelve participants will complete monthly visits. Phone counseling will be available for participants who are unable or prefer not to attend counseling at the clinic and in person. In addition, a 24-hour quit line will be made available for participants who need more support for quitting smoking. On a monthly basis, the participants will come to the clinic and complete carbon monoxide (CO) test via Smokerlyzer® and cotinine urine tests by providing a urine sample to monitor their smoking cessation progress. Measurements will coincide with their counseling visits. In addition, participants will receive two pamphlets at baseline; one outlining healthy nutritional guidelines and one outlining physical activity guidelines for adults. At baseline, participants will complete the EQ-5D-3L to assess health status, the Modifiable Activity Questionnaire (MAQ) to assess past month leisure-time and occupational physical activity, and the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) assessment to assess willingness to make changes in physical activity and nutrition behaviors (Taylor et al, 2004). At 3 months, 6 months, and 1 year, participants will complete the PACE activity willingness questionnaire, the Modifiable Activity Questionnaire (MAQ), the EQ-5D-3L to assess perception of health, and the Minnesota Nicotine Withdrawal Scale to assess withdrawal symptoms.
Physical Activity and Nutrition Intervention
Participants randomized to the PASC arm will receive individual physical activity and group-based nutritional counseling in addition to standard treatment. Participants will receive instruction at baseline on how to wear a pedometer correctly and be asked to wear it and record steps for one week and will be assessed at their first smoking cessation visit. Participants will then return for their second smoking cessation session for a one-hour session on the guidelines for physical activity for adults (10,000 steps per day, 150 minutes of moderate physical activity per week, or 30 minutes 5 days per week) and how to monitor their physical activity and set goals. Participants will receive follow-up phone calls each week to collect step counts and weekly activity minutes and discuss weekly goal setting for physical activity. Weekly follow-up calls will occur throughout the first 3 months (12 weeks) of the study. Monthly evaluation of physical activity goals will occur during monthly counseling appointments. At 3 months, 6 months, and 1 year, PASC arm participants will be asked to report step counts for one (1) week prior to their assessment visit. In addition to physical activity intervention, PASC participants will receive three (3) one-hour group nutrition counseling sessions delivered at start of intervention, 3 months, and 6 months. The nutrition counseling will be delivered in group sessions by a licensed dietician. Materials distributed during the first counseling session will include suggested meal plans for calorie reduction (1200, 1500, and 1800 calories), information on portion sizes, information on essential vitamins and minerals, and guidelines for fat gram intake goals. The second group nutrition session at 3 months will include information on dining out, mindful eating, and a re-emphasis on portion sizes and food selection. The third group nutrition session at 6 months will include trouble-shooting, sports-nutrition counseling, and evaluation of eating habits. At each time point (baseline, 3 months, 6 months), multiple sessions will be offered spanning multiple weekdays and times of day (morning, noon, evening).
Outcomes
Physical activity levels and smoking cessation will be measured during the study using various tools. Physical activity level will be assessed by measuring the number of steps taken daily by the participant using Accusplit AE120XL pedometers. The number of steps will be measured and reported on a weekly basis for the first twelve (12) weeks of the intervention. After the first 12 weeks, physical activity level will be assessed every three months using the Modifiable Activity Questionnaire (MAQ), which assesses the participant’s leisure and occupational activity in the past month, and by reporting steps for the prior 7-days. Participant’s activity level will be able to be evaluated over time, comparing the results to his/her baseline data. Willingness to change behaviors related to physical activity and nutrition will be measured via the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) at baseline, 3 months, 6 months, and 12 months. The EuroQol Group EQ-5D-3L will be used to measure perceived health status at baseline, 3 months, 6 months, and 12 months. Smoking cessation will be assessed weekly for the first month by measuring carbon monoxide levels and levels of cotinine in the urine. Carbon monoxide values will be collected using Smokerlyzer® (Bedfont Scientific Ltd., piCO+™). NicAlertTM urine test strips will be used to measure cotinine levels in the urine. Withdrawal symptoms will also be measured weekly for the first month, using the Minnesota Nicotine Withdrawal Scale; inquiring about daily use of nicotine, symptoms following the stop or reduction of nicotine use, as well as impact of daily functioning, while monitoring for symptoms due to a general medical or mental condition. These measures will be collected bi-weekly from baseline until the end of month 2 (eight weeks). Then, measurement collection will happen monthly until the conclusion of the trial at month 12. Measurement collection will occur during one-on-one counseling sessions with the clinic expert.
Additionally, weight loss will be assessed as a percent weight loss from weight at baseline. Weight will be measured on a weekly basis for the first 12 weeks and then monthly up to 12 months using the Detecto ProDoc PD100 scale.
Sample Size Calculation
We used the study by Prapavessis et al. as a guide to estimate the sample size (2007). The investigators studied differences in 4 different groups (1) exercise + nicotine patch (2) exercise + no nicotine patch (3) cognitive behavior therapy (CBT) + nicotine patch and (4) cognitive behavior therapy + no nicotine patch. The 12 month cessation rates were 15 % for the CBT + patch group and 27% for the exercise + patch group. We used University of Iowa website (http://homepage.cs.uiowa.edu/~rlenth/Power/) for the calculation of sample size. “Test comparing two proportions” was selected for analysis. We choose 15% as the cessation rate for the standard treatment group (Nicotine replacement therapy + counseling) and 30 % for the treatment group (Physical activity + Nicotine replacement therapy + counseling) to detect a between group difference of 15 percentage points or a 50% increase in cessation success. Alpha was set at 0.025 to allow for multiple comparisons. We calculated sample size requirements for 80% power. This resulted in a total sample size of 320 (160 in each group). Results of an array of power calculations are summarized in Table 1. We expect a 75% retention rate based on the study by Steinberg et al (2009). When the sample size is adjusted for the 25% drop out rate, the sample size required is 426 (213 per group).
Table 1. Sample Size for Test Comparing Two Proportions (Smoking Cessation)
Treatment group
Control group
Power
Sample size
Sample size adjusted for 75% retention
15%
25%
80
646 (323 in each group)
861
15%
25%
90
830 (415 In each group)
1106
15%
30%
80
320 (160 in each group)
426
15%
30%
90
408 (204 in each group)
544
Weight loss will be reported as a percentage of initial body weight reduction.
The outcome will be continuous. Aligning with the goals of the intervention, the PASC arm is anticipated to have a 5% weight loss at 6 months of follow-up. The comparator arm is anticipated to have no weight loss or potential weight gain. Using estimates of mean weight loss of 0% for the comparator arm and 5% weight loss in the PASC arm and a range of estimates for standard deviation (0.5x the mean, equal to the mean, and 1.5x the mean), we calculated sample size requirements for 80% and 90% power using SAS 9.3 procedure for difference between means with alpha set at 0.025 to allow for multiple comparisons. The resulting sample sizes are summarized in Table 2. We have selected the most conservative estimate for sample size as our target for recruitment. Adjusted for the 75% retention rate, our target sample size for 80% power, alpha level of 0.025 is 120 (60 per
group).
Table 2. Sample Size for Test of Mean Difference (Weight Loss)
Treatment group
Control group
Standard Deviation
Power
Sample size
Sample size adjusted for 75% retention
5%
0%
2.5
80
14 (7 in each group)
20
5%
0%
2.5
90
16 (8 in each group)
22
5%
0%
5.0
80
42 (21 in each group)
56
5%
0%
5.0
90
54 (27 in each group)
72
5%
0%
7.5
80
90 (45 in each group)
120
5%
0%
7.5
90
116 (58 in each group)
156
For this study, we will recruit based on the sample size needed to detect a difference in smoking cessation rates of 15% between groups, with a 50% increase in cessation success in the treatment arm. Therefore, our target enrollment is 426 participants, 213 for each intervention arm.
Analysis Plan
For variables presented in Table 3, independent samples t-tests for continuous variables and χ2 test for categorical variables at alpha level of 0.05 will be conducted to assess differences in characteristics between treatment group and active comparator at time of randomization (baseline). Significant differences in groups will be defined as mean differences with an associated p-value 1 pack/day, 1 year, 7d/w
Previous attempts to quit
Dichotomous
Yes/No
We will use intention-to-treat analysis to conduct all primary statistical analysis. Before using statistical analysis for comparison of outcomes between treatment groups, box plots for continuous variables and proportions for dichotomous variables will be compared to visually detect differences. Exploratory data analysis using graphical methods will be used to determine the type of variable to use for the predictors cigarettes, household income, duration of smoking, and alcohol use. Box plots, quartiles, interquartile ranges, and frequency distributions will be used to determine categorical cut-points. Additionally, exploratory data analysis for differences in cessation rates and weight loss by gender will be conducted by using graphical analysis.
The primary outcomes of the study are smoking cessation rates, withdrawal symptoms, weight loss, duration of abstinence and quality of life. Smoking cessation is a categorical variable and will perform a chi-square test of two proportions (χ ²) to compare cessation rates between groups. Other primary outcomes are measured as continuous variables and an independent two sample t-test will be performed to compare the means of the two groups. An alpha of 0.025 will be used to determine statistically significant differences.
After conducting independent samples t-tests and chi-square test of two proportions for primary outcomes to see if there is a statistically significant difference between the mean values of treatment groups, appropriate regression models for each outcome will be run to include any possible predictors and confounders, and to determine if the differences between treatment groups remain.
First, univariate analysis for the predictors (treatment group, duration of smoking, cigarettes, age, sex, alcohol use, BMI, income, and previous attempts to quit) will be run to determine independent effects on the outcomes (smoking cessation, weight loss, time of abstinence, withdrawal symptoms, quality of life, and stage of willingness to make lifestyle changes). Predictors with a Wald test statistic with a p-value of < 0.10 will be kept in the multivariate models.
To determine factors associated with smoking cessation, defined as 0=no and 1=yes, logistic regression for treatment group on smoking cessation will be used to calculate an odds ratio, adjusted for independence from predictors. Treatment group will be considered an independent predictor of smoking cessation if the Wald test with a Chi-square distribution yields a p-value