A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy, acceptability, and feasibility of an intervention that provides a behavioral weight gain prevention intervention in advance of smoking cessation treatment in individuals with overweight or obesity who smoke cigarettes. The primary aim of this study is to determine feasibility and acceptability and initial efficacy regarding whether preceding 8 weeks of smoking cessation treatment with 8 weeks of self-regulation strategies + large changes for weight gain prevention (SR), compared to 8 weeks of healthy lifestyle education (LE), will result in greater smoking cessation and reduced weight gain. Secondary aims are to study effects on self-efficacy for managing weight and for quitting smoking, negative affect, and delayed reward discounting. Methods: Individuals with overweight or obesity who smoke cigarettes will participate in a 16-week group-based multiple health behavior change intervention. Groups will be randomly assigned to receive either 8 weeks of SR followed by 8 weeks of smoking cessation treatment or 8 weeks of LE followed by 8 weeks of smoking cessation treatment. Smoking cessation treatment in both conditions will include counseling and combination nicotine replacement therapy (patch + lozenges), with a quit day at week 9 of the 16-week intervention. Assessments will occur at baseline, on quit day and 1, 2, and 3 months later. Determining the viability of this strategy in terms of effects on both smoking and weight has high significance to public health.

Detailed Description
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Aims - The specific aims are to examine: (1) the feasibility, acceptability, and initial efficacy of using self-regulation strategies for weight gain prevention (SR), relative to the provision of healthy lifestyle education (LE), prior to smoking cessation treatment in a pilot study; (2) compare the effect of self-regulation strategies for weight gain prevention (SR), relative to the provision of healthy lifestyle education (LE), prior to smoking cessation treatment, on mechanisms thought to underlie smoking abstinence. Mechanisms include self-efficacy for managing weight and for quitting smoking, negative affect, and delayed reward discounting. Methodology - A randomized trial will be used to test the feasibility, acceptability, and initial efficacy of using self-regulation strategies for weight gain prevention prior to smoking cessation treatment. Eligible participants will complete baseline assessment and be randomly assigned to one of two conditions. Participants assigned to the SR condition will receive 8 weeks of self-regulation strategies + large changes for weight gain prevention, followed by 8 weeks of smoking cessation treatment. Participants assigned to the LE condition will receive 8 weeks of healthy lifestyle education, followed by 8 weeks of smoking cessation treatment. The intervention will be delivered using a group-based format and will last 16 weeks. Random assignment will occur at the group level. Participants will receive nicotine replacement therapy and counseling as part of the smoking cessation intervention and will quit smoking as a group halfway through treatment (week 9). Assessments will occur at baseline, on quit day (week 9), 1 month after quit day (week 13), 2 months after quit day (week 17), and 3 months after quit day (week 21). Approximately 30 participants will be assigned to each condition (study N=60). Participant Population - Individuals with overweight or obesity who smoke cigarettes

Official Title
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A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

Conditions
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Smoking Cessation, Obesity

Intervention / Treatment
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* Behavioral: Self-Regulation strategies + large changes (SR)
* Behavioral: Healthy Lifestyle Education (LE)
* Other: Smoking Cessation Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 25 kg/m2 smoked ≥ 5 cigarettes/day during the past year self-reported motivation to quit smoking self-reported desire to prevent or minimize weight gain during smoking cessation ability to understand informed consent access to a smartphone or tablet Exclusion Criteria: current smoking cessation or weight loss treatment/medication more than 1 day/week use of tobacco or nicotine from sources other than cigarettes (other than non-daily use of e-cigarettes in addition to combustible cigarettes) weight loss of 20 lbs or more within the past 6 months self-reported diagnosis or treatment for an alcohol or substance use disorder within the past 6 months (with the exception of maintenance therapies) endorsing recent symptomology suggestive of an eating disorder, an alcohol or substance use disorder, severe depression, or suicidal ideation self-reported diagnosis or treatment or evidence of an eating disorder or severe psychiatric disorder (e.g., schizophrenia or bipolar disorder) not stabilized on psychotropic medications current use of medications known to interact with smoking cessation clinically significant medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of the two study conditions at the group level after they have completed baseline assessment. The principal investigator, who is not involved in conducting assessments, will use a random number generator to determine assignment. Participants will learn their condition assignment during their first group session. The interventionist will use a detailed intervention manual to ensure standardization of treatment delivery.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Regulation strategies + large changes (SR)<br>This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment | Behavioral: Self-Regulation strategies + large changes (SR)<br>* The first 8 weeks (weeks 1-8) of the 16-week program will include weekly group sessions focused on teaching self-regulation and efforts to produce a 10 lb weight loss to buffer against anticipated post-cessation weight gain. Participants will be taught the core self-regulation skills for controlling their weight. In order to produce an initial weight loss buffer, they will be instructed to self-monitor their intake, given a daily calorie goal, and taught strategies for reducing caloric intake. Structured physical activity, such as brisk walking will also be prescribed and self-monitored. During smoking cessation treatment (weeks 9-16), participants will be asked to continue to use self-regulation skills for monitoring their weight and to use a color zone system (red, yellow, green) to determine what course of action to follow based on whether changes in weight have occurred.<br>Other: Smoking Cessation Treatment<br>* The second 8 weeks (weeks 9-16) of the 16-week program will include weekly group counseling sessions focused on smoking cessation. The smoking cessation treatment provided will be the same in both arms of the study. In preparation of quitting, nicotine replacement therapy lozenges will be provided for 3 weeks prior to quitting (weeks 6-8). A group quit day will occur on week 9. During the smoking cessation portion of treatment (weeks 9-16), participants will be provided with combination nicotine replacement therapy (patches + lozenges) and daily supportive text messages.<br>|
| Active Comparator: Healthy Lifestyle Education (LE)<br>This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment | Behavioral: Healthy Lifestyle Education (LE)<br>* The first 8 weeks (weeks 1-8) of the 16-week program will include weekly group sessions focused on living a healthy lifestyle. Information provided will include education on why weight gain happens while quitting smoking, principles of healthy eating (e.g., simple versus complex carbohydrates), physical activity guidelines, and other topics related to living a healthy lifestyle. Participants can choose to use the healthy lifestyle information and education provided however they would like. Participants will not be asked to use self-regulation strategies during either part of the 16-week program.<br>Other: Smoking Cessation Treatment<br>* The second 8 weeks (weeks 9-16) of the 16-week program will include weekly group counseling sessions focused on smoking cessation. The smoking cessation treatment provided will be the same in both arms of the study. In preparation of quitting, nicotine replacement therapy lozenges will be provided for 3 weeks prior to quitting (weeks 6-8). A group quit day will occur on week 9. During the smoking cessation portion of treatment (weeks 9-16), participants will be provided with combination nicotine replacement therapy (patches + lozenges) and daily supportive text messages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point-prevalence abstinence from smoking | biochemically-verified 7-day-point prevalence abstinence from smoking | 2 months post-quit (end of treatment) | 
| Weight Change | body weight (lbs) | change from baseline to week 9 (quit day) to 1, 2, 3 months post-quit | 
| Treatment attendance | The percentage of treatment sessions attended through week 10 (one week post-quit) will be used as a measure of attendance to demonstrate feasibility and acceptability | Treatment weeks 1-10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point-prevalence abstinence from smoking | biochemically-verified 7-day-point prevalence abstinence from smoking | week 9 (quit day), 1, 2, 3 months post-quit | 
| Number of cigarettes smoked/day | Timeline Follow Back (TLFB) interview will assess self-reported number of cigarettes smoked each day, summed over past 28 days | week 9 (quit day), 1, 2, 3 months post-quit | 
| Achievement of ≥50% reduction in cigarettes per day smoked | Relative to baseline, whether number of cigarettes smoked in the past 28 days has decreased by ≥50% | week 9 (quit day), 1, 2, 3 months post-quit | 
| Duration of longest period of abstinence from smoking | Timeline Follow Back (TLFB) interview will assess self-reported smoking abstinence each day. The longest number of contiguous abstinence days will be recorded starting at quit day. | 1, 2, 3 months post-quit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, smoking cessation, smoking treatment, quitting smoking, obesity, overweight, multiple health behavior change intervention