A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

Obesity Clinical Trial

Official title:

A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05136430
• Other study ID #: 1608001567
• Secondary ID: K23DA045078
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 2025

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aims - The specific aims are to examine: (1) the feasibility, acceptability, and initial efficacy of using self-regulation strategies for weight gain prevention (SR), relative to the provision of healthy lifestyle education (LE), prior to smoking cessation treatment in a pilot study; (2) compare the effect of self-regulation strategies for weight gain prevention (SR), relative to the provision of healthy lifestyle education (LE), prior to smoking cessation treatment, on mechanisms thought to underlie smoking abstinence. Mechanisms include self-efficacy for managing weight and for quitting smoking, negative affect, and delayed reward discounting.

Methodology - A randomized trial will be used to test the feasibility, acceptability, and initial efficacy of using self-regulation strategies for weight gain prevention prior to smoking cessation treatment. Eligible participants will complete baseline assessment and be randomly assigned to one of two conditions. Participants assigned to the SR condition will receive 8 weeks of self-regulation strategies + large changes for weight gain prevention, followed by 8 weeks of smoking cessation treatment. Participants assigned to the LE condition will receive 8 weeks of healthy lifestyle education, followed by 8 weeks of smoking cessation treatment. The intervention will be delivered using a group-based format and will last 16 weeks. Random assignment will occur at the group level. Participants will receive nicotine replacement therapy and counseling as part of the smoking cessation intervention and will quit smoking as a group halfway through treatment (week 9). Assessments will occur at baseline, on quit day (week 9), 1 month after quit day (week 13), 2 months after quit day (week 17), and 3 months after quit day (week 21). Approximately 30 participants will be assigned to each condition (study N=60).

Participant Population - Individuals with overweight or obesity who smoke cigarettes

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• BMI = 25 kg/m2

• smoked = 5 cigarettes/day during the past year

• self-reported motivation to quit smoking

• self-reported desire to prevent or minimize weight gain during smoking cessation

• ability to understand informed consent

• access to a smartphone or tablet

Exclusion Criteria:

• current smoking cessation or weight loss treatment/medication

• more than 1 day/week use of tobacco or nicotine from sources other than cigarettes (other than non-daily use of e-cigarettes in addition to combustible cigarettes)

• weight loss of 20 lbs or more within the past 6 months

• self-reported diagnosis or treatment for an alcohol or substance use disorder within the past 6 months (with the exception of maintenance therapies)

• endorsing recent symptomology suggestive of an eating disorder, an alcohol or substance use disorder, severe depression, or suicidal ideation

• self-reported diagnosis or treatment or evidence of an eating disorder or severe psychiatric disorder (e.g., schizophrenia or bipolar disorder)

• not stabilized on psychotropic medications

• current use of medications known to interact with smoking cessation

• clinically significant medical condition

Related Conditions & MeSH terms

• Obesity
• Overweight
• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-efficacy for quitting smoking	The Smoking Self-Efficacy Questionnaire will be used to compare baseline to quit day. Scores range from 12 to 60; higher scores indicate a better outcome.	week 9 (quit day)
Other	Self-efficacy for weight management after quitting smoking	The Weight-Efficacy After Quitting scale will be used to compare baseline to quit day. Scores range from 6 to 60; higher scores indicate a better outcome.	week 9 (quit day)
Other	Delay discounting	The Monetary Choice Questionnaire will be used to compare baseline to quit day. Responses will be used to calculate discount rate (k), and the proportion of immediate reward choices; higher values indicate more impulsivity.	week 9 (quit day)
Other	Negative affect	Negative affect will be assessed using a measure called the Positive and Negative Affective Schedule. It will be used to compare baseline to quit day; higher values indicate higher negative affect.	week 9 (quit day)
Other	Treatment satisfaction	Treatment satisfaction during the first half of treatment will be assessed via questionnaire, with higher scores indicating greater satisfaction.	week 9 (quit day)
Other	Study retention	The percentage of participants completing the final outcome assessment will be used to determine study retention.	3 months post-quit (end of study)
Primary	7-day point-prevalence abstinence from smoking	biochemically-verified 7-day-point prevalence abstinence from smoking	2 months post-quit (end of treatment)
Primary	Weight Change	body weight (lbs)	change from baseline to week 9 (quit day) to 1, 2, 3 months post-quit
Primary	Treatment attendance	The percentage of treatment sessions attended through week 10 (one week post-quit) will be used as a measure of attendance to demonstrate feasibility and acceptability	Treatment weeks 1-10
Secondary	7-day point-prevalence abstinence from smoking	biochemically-verified 7-day-point prevalence abstinence from smoking	week 9 (quit day), 1, 2, 3 months post-quit
Secondary	Number of cigarettes smoked/day	Timeline Follow Back (TLFB) interview will assess self-reported number of cigarettes smoked each day, summed over past 28 days	week 9 (quit day), 1, 2, 3 months post-quit
Secondary	Achievement of =50% reduction in cigarettes per day smoked	Relative to baseline, whether number of cigarettes smoked in the past 28 days has decreased by =50%	week 9 (quit day), 1, 2, 3 months post-quit
Secondary	Duration of longest period of abstinence from smoking	Timeline Follow Back (TLFB) interview will assess self-reported smoking abstinence each day. The longest number of contiguous abstinence days will be recorded starting at quit day.	1, 2, 3 months post-quit