N/A
N=305
Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
Weight Change, Body · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03156660 ↗Enrolled (actual)
305
Serious AEs
14.1%
Results posted
Apr 2023
Primary outcome: Primary: Weight — -0.24; -1.11; 1.25 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight gain prevention (Group 1) (Behavioral); Weight loss intervention (Group 2) (Behavioral); Self-guided intervention (Group 3) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Tennessee
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
-0.24; -1.11; 1.25 | — |
| PRIMARY Point Prevalence Tobacco Abstinence |
39; 49; 41 | — |
Summary
The study aims to randomize 400 participants to 1 of 3 arms: a) a weight stability intervention prior to smoking cessation (Group 1); b) a weight loss intervention prior to smoking cessation (Group 2); or c) a self-guided weight management prior to cessation (Group 3) and to determine the efficacy of the interventions on preventing weight gain at 12 month follow-up. All 3 conditions receive a highly efficacious behavioral smoking cessation program and 6 months of varenicline pharmacotherapy (ChantixTM), the most efficacious medication for smoking cessation.
Eligibility Criteria
Inclusion Criteria
- Participants must wish to quit smoking in the next 30 days
- Have smoked 5 or more cigarettes a day for at least 1 year
- Participants must be 18 years or older as the safety and efficacy of varenicline therapy has not been established for pediatric patients
- Participants must have a BMI of 22 kg/m2 or greater, as it would not be recommended to have those who are underweight or the lower end of the normal BMI range attempt a 5% weight loss (if assigned to the Group 2 condition)
- Participants must have access to a telephone and daily access to email, if using a cell phone, participants must be willing to use their cell phone minutes for weekly phone interventions
- Participants must have the ability to understand consent process in English
- If female and of childbearing age, participant must have a negative pregnancy test and must agree to use contraception during participation in the study
- All participants must be willing to be randomized to the study conditions and wait eight weeks prior to beginning smoking cessation (during which they will participate in the weight management intervention to which they are assigned).
- Participants must have BP 40 beats per minute and or equal to10 lbs in the past 6 months
- Participants must not be taking a medication that impacts weight
- Participants must not have used an investigational drug within the last 30 days
- Participants must not have current suicidal thoughts or have a lifetime history of a suicide attempt as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Participants must not self-report a history of psychosis, bipolar disorder, or anorexia nervosa
- Participants must not have self-reported current alcohol abuse or illicit substance use
- Participants must not have kidney or liver disease, unstable cardiovascular conditions, HIV, or history of cancer in last 5 years
- Participants must not have another member of their household already participating in this study
- Participants must not be currently pregnant or lactating or planning to become pregnant in the next 12 months, or have been pregnant within the last 6 months
- Weight limit of 385 pounds
Data sourced from ClinicalTrials.gov (NCT03156660). 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.