common.study.topics.clinical

Efficacy of Two Novel Behavioral Post-Cessation Weight Gain Interventions

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Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

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.

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No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Behavioral - Weight gain prevention (Group 1)

Participants will be asked to keep their weight stable during the initial 8 weeks of the study. Intervention Components: Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day). Daily self-monitoring of steps and number of Small Changes Daily weight self-monitoring on the BodyTraceTM e-scale Fit Bit Alta activity trackers to self-mo ...read more on ClinicalTrials.org

Behavioral - Weight loss intervention (Group 2)

Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8. Intervention Components: Tailored calorie and fat goals based on their baseline weight. Daily dietary intake and physical activity self-monitoring using a website or app. Daily weight self-monitoring on the BodyTraceTM e-scale Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention Meal replacements for two meals and one snack for 8 weeks as a method t ...read more on ClinicalTrials.org

Behavioral - Self-guided intervention (Group 3)

Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book. Intervention Components: EatingWell Diet book. Daily weight self-monitoring on the BodyTraceTM e-scale

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Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

common.study.values.clinical-trial-id

NCT03156660

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penARd