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NCT05136430 · ClinicalTrials.gov registry record · NA
A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
A NA study of Obesity and Smoking Cessation, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05136430 is a NA study of Obesity and Smoking Cessation that has completed, run by Brown University. The registered enrollment target is 55 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05136430, a NA study of Obesity and Smoking Cessation, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Self-Regulation strategies + large changes (SR)
- BEHAVIORAL Healthy Lifestyle Education (LE)
- OTHER Smoking Cessation Treatment
Study Locations (1)
Rhode Island
- Brown University School of Public Health - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2024-01-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05136430
The ClinicalTrials.gov registry entry for NCT05136430 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Self-Regulation strategies + large changes (SR) is the first listed.
NCT05136430 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05136430 about?
NCT05136430 is a clinical study titled "A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers". 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 s...
What is the current status of trial NCT05136430?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2021-11-01. Estimated completion is 2024-01-10.
What conditions does trial NCT05136430 study?
This clinical trial studies the following conditions: Obesity, Smoking Cessation.
What interventions are being tested in trial NCT05136430?
The interventions under investigation include: Self-Regulation strategies + large changes (SR) (BEHAVIORAL), Healthy Lifestyle Education (LE) (BEHAVIORAL), Smoking Cessation Treatment (OTHER).
Who is sponsoring clinical trial NCT05136430?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05136430 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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