A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

Not Applicable

Completed

Conditions: Smoking Cessation
Obesity

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

Registration Number: NCT05136430

Lead Sponsor: Brown University

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Regulation strategies + large changes (SR)	Smoking Cessation Treatment	This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment
Self-Regulation strategies + large changes (SR)	Self-Regulation strategies + large changes (SR)	This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment
Healthy Lifestyle Education (LE)	Healthy Lifestyle Education (LE)	This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment
Healthy Lifestyle Education (LE)	Smoking Cessation Treatment	This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants With 7-day Point-prevalence Abstinence From Smoking	2 months post-quit (end of treatment)	The number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Treatment Attendance	Treatment weeks 1-10	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
Weight Change	change in weight from baseline to 2 months post-quit (end of treatment)	body weight (lbs)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With 7-day Point-prevalence Abstinence From Smoking	1 months post-quit (end of treatment)	Number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Number of Cigarettes Smoked/Day	2 months post-quit (end of treatment)	Timeline Follow Back (TLFB) interview will assess self-reported number of cigarettes smoked each day, summed over past 28 days
Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked	2 months post-quit (end of treatment)	The number of participants for whom the number of cigarettes smoked per day in the past 7 days has decreased by ≥50%, relative to the number of cigarettes the participant smoked per day at baseline.
Duration of Longest Period of Abstinence From Smoking	2 months post-quit (end of treatment)	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.