Clinical trial NCT05136430: A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
Official title: A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Obesity
Keywords: smoking
smoking cessation
smoking treatment
quitting smoking
obesity
overweight
multiple health behavior change intervention
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-11-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With 7-day Point-prevalence Abstinence From Smoking
timeFrame: 2 months post-quit (end of treatment)
measure: Weight Change
timeFrame: change in weight from baseline to 2 months post-quit (end of treatment)
measure: Treatment Attendance
timeFrame: Treatment weeks 1-10
Secondary outcomes:
measure: Number of Participants With 7-day Point-prevalence Abstinence From Smoking
timeFrame: 1 months post-quit (end of treatment)
measure: Number of Cigarettes Smoked/Day
timeFrame: 2 months post-quit (end of treatment)
measure: Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked
timeFrame: 2 months post-quit (end of treatment)
measure: Duration of Longest Period of Abstinence From Smoking
timeFrame: 2 months post-quit (end of treatment)
Other outcomes:
measure: Self-efficacy for Quitting Smoking
timeFrame: week 9 (quit day)
measure: Study Retention
timeFrame: 3 months post-quit (end of study)
measure: Self-efficacy for Weight Management After Quitting Smoking
timeFrame: week 9 (quit day)
measure: Delay Discounting
timeFrame: week 9 (quit day)
measure: Negative Affect Score
timeFrame: week 9 (quit day)
measure: Treatment Satisfaction
timeFrame: week 9 (quit day)
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
References: