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Health Behavior Change Intervention for Smoking Cessation

N/A
Waitlist Available
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
self-reported motivation to quit smoking
self-reported desire to prevent or minimize weight gain during smoking cessation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3 months post-quit
Awards & highlights

Study Summary

This trial is testing whether an 8-week intervention of self-regulation strategies + large changes for weight gain prevention can help people who are overweight or obese to quit smoking cigarettes, and whether this is more effective than an 8-week intervention of healthy lifestyle education.

Who is the study for?
This trial is for overweight or obese individuals who smoke at least 5 cigarettes a day, want to quit smoking without gaining weight, and are motivated to stop. They must have a BMI of 25 or higher and be able to use a smartphone or tablet. People with severe psychiatric disorders, recent substance abuse treatment, current smoking cessation or weight loss treatments are excluded.Check my eligibility
What is being tested?
The study tests if teaching self-regulation strategies for preventing weight gain before quitting smoking helps more than just healthy lifestyle education. Participants will get either an 8-week course on these strategies followed by an 8-week smoking cessation program, or the same duration of lifestyle education then quitting help.See study design
What are the potential side effects?
Possible side effects may include discomfort from nicotine replacement therapy (like skin irritation from patches or mouth issues from lozenges), stress due to behavior change efforts, and potential withdrawal symptoms associated with quitting smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am motivated to quit smoking.
Select...
I want to avoid gaining weight while I quit smoking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3 months post-quit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3 months post-quit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment attendance
Weight Change
Secondary outcome measures
7-day point-prevalence abstinence from smoking
Achievement of ≥50% reduction in cigarettes per day smoked
Duration of longest period of abstinence from smoking
+1 more
Other outcome measures
Delay discounting
Negative affect
Self-efficacy for quitting smoking
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Regulation strategies + large changes (SR)Experimental Treatment2 Interventions
This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment
Group II: Healthy Lifestyle Education (LE)Active Control2 Interventions
This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
563,021 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,573 Total Patients Enrolled

Media Library

Healthy Lifestyle Education (LE) Clinical Trial Eligibility Overview. Trial Name: NCT05136430 — N/A
Smoking Cessation Research Study Groups: Self-Regulation strategies + large changes (SR), Healthy Lifestyle Education (LE)
Smoking Cessation Clinical Trial 2023: Healthy Lifestyle Education (LE) Highlights & Side Effects. Trial Name: NCT05136430 — N/A
Healthy Lifestyle Education (LE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05136430 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment count for this research project?

"Affirmative, the clinicaltrials.gov platform has information that this experiment is presently enrolling individuals for participation. The trial was initially published on November 1st 2021 and updated most recently on December 3rd 2021. This research necessitates 60 volunteers from a single location."

Answered by AI

Are there any opportunities to enroll in this research experiment at present?

"Clinicaltrials.gov verifies that this investigation is currently recruiting volunteers, having been posted on the 1st of November 2021 and updated as recently as December 3rd."

Answered by AI

Does this clinical experiment accept enrollees who are of advanced age?

"The parameters for this medical trial require that applicants are aged 18 to 75. For younger participants, there is a pool of 228 clinical trials available and 829 if the patient has passed 65 years old."

Answered by AI

Are there any requirements for me to be eligible to join this experiment?

"60 participants are being recruited for this medical trial, with eligibility requirements of obesity and an age range between 18 to 75."

Answered by AI

What is the proposed outcome of this experiment?

"This clinical trial will evaluate the frequency of patient attendance. Secondary outcomes to be measured are 7-day point abstinence from smoking, a 50% reduction in cigarettes smoked daily (based on baseline) and an average number of cigarettes smoked per day over 28 days collected via Timeline Follow Back interviews. All assessments will take place between week 9 (quit day) and 3 months post cessation time frame."

Answered by AI

Who else is applying?

What site did they apply to?
Brown University School of Public Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
Cara Murphy 2021. "A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136430.
All > Smoking > Overweight
~9 spots leftby Oct 2024
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