A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

NACompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

January 10, 2024

Study Completion Date

January 10, 2024

Conditions
Smoking CessationObesity
Interventions
BEHAVIORAL

Self-Regulation strategies + large changes (SR)

The first 8 weeks (weeks 1-8) of the 16-week program will include weekly group sessions focused on teaching self-regulation and efforts to produce a 10 lb weight loss to buffer against anticipated post-cessation weight gain. Participants will be taught the core self-regulation skills for controlling their weight. In order to produce an initial weight loss buffer, they will be instructed to self-monitor their intake, given a daily calorie goal, and taught strategies for reducing caloric intake. Structured physical activity, such as brisk walking will also be prescribed and self-monitored. During smoking cessation treatment (weeks 9-16), participants will be asked to continue to use self-regulation skills for monitoring their weight and to use a color zone system (red, yellow, green) to determine what course of action to follow based on whether changes in weight have occurred.

BEHAVIORAL

Healthy Lifestyle Education (LE)

The first 8 weeks (weeks 1-8) of the 16-week program will include weekly group sessions focused on living a healthy lifestyle. Information provided will include education on why weight gain happens while quitting smoking, principles of healthy eating (e.g., simple versus complex carbohydrates), physical activity guidelines, and other topics related to living a healthy lifestyle. Participants can choose to use the healthy lifestyle information and education provided however they would like. Participants will not be asked to use self-regulation strategies during either part of the 16-week program.

OTHER

Smoking Cessation Treatment

The second 8 weeks (weeks 9-16) of the 16-week program will include weekly group counseling sessions focused on smoking cessation. The smoking cessation treatment provided will be the same in both arms of the study. In preparation of quitting, nicotine replacement therapy lozenges will be provided for 3 weeks prior to quitting (weeks 6-8). A group quit day will occur on week 9. During the smoking cessation portion of treatment (weeks 9-16), participants will be provided with combination nicotine replacement therapy (patches + lozenges) and daily supportive text messages.

Trial Locations (1)

02912

Brown University School of Public Health, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Brown University

OTHER

NCT05136430 - A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers | Biotech Hunter | Biotech Hunter