N/A
N=55
A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
Smoking Cessation · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05136430 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With 7-day Point-prevalence Abstinence From Smoking — 11; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-Regulation strategies + large changes (SR) (Behavioral); Healthy Lifestyle Education (LE) (Behavioral); Smoking Cessation Treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 7-day Point-prevalence Abstinence From Smoking |
13; 13 | — |
| PRIMARY Weight Change |
-5.3; .03 | — |
| PRIMARY Treatment Attendance |
85.2; 90.7 | — |
| SECONDARY Number of Participants With 7-day Point-prevalence Abstinence From Smoking |
13; 13 | — |
| SECONDARY Number of Cigarettes Smoked/Day |
1.9; 1.6 | — |
| SECONDARY Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked |
24; 26 | — |
| SECONDARY Duration of Longest Period of Abstinence From Smoking |
29.1; 40.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05136430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.