A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

NCT05136430 | Completed Results

• 2 other identifiers: 1608001567K23DA045078
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Obesity

Keywords

smoking; smoking cessation; smoking treatment; quitting smoking; obesity; overweight; multiple health behavior change intervention

Outcome Measures

Primary Outcomes (3)

• Number of Participants With 7-day Point-prevalence Abstinence From Smoking

  The number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking

  2 months post-quit (end of treatment)

• Weight Change

  body weight (lbs)

  change in weight from baseline to 2 months post-quit (end of treatment)

• 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 Outcomes (4)

• Number of Participants With 7-day Point-prevalence Abstinence From Smoking

  1 months post-quit (end of treatment)

• Number of Cigarettes Smoked/Day

  2 months post-quit (end of treatment)

• Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked

  2 months post-quit (end of treatment)

• Duration of Longest Period of Abstinence From Smoking

  2 months post-quit (end of treatment)

Other Outcomes (6)

• Self-efficacy for Quitting Smoking

  week 9 (quit day)

• Study Retention

  3 months post-quit (end of study)

• Self-efficacy for Weight Management After Quitting Smoking

  week 9 (quit day)

Study Arms (2)

Self-Regulation strategies + large changes (SR)

EXPERIMENTAL

This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment

Behavioral: Self-Regulation strategies + large changes (SR); Other: Smoking Cessation Treatment

Healthy Lifestyle Education (LE)

ACTIVE COMPARATOR

This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment

Behavioral: Healthy Lifestyle Education (LE); Other: Smoking Cessation Treatment

Interventions

Self-Regulation strategies + large changes (SR) BEHAVIORAL

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.

Self-Regulation strategies + large changes (SR)

Healthy Lifestyle Education (LE) BEHAVIORAL

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.

Healthy Lifestyle Education (LE)

Smoking Cessation Treatment OTHER

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.

Healthy Lifestyle Education (LE); Self-Regulation strategies + large changes (SR)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Obesity; Smoking; Overweight

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cara M. Murphy, Ph.D.
• Organization: Brown University

murphybrownlab@brown.edu

4018636519

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know condition assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to one of the two study conditions at the group level after they have completed baseline assessment. The principal investigator, who is not involved in conducting assessments, will use a random number generator to determine assignment. Participants will learn their condition assignment during their first group session. The interventionist will use a detailed intervention manual to ensure standardization of treatment delivery.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 29, 2021
• Study Start: November 1, 2021
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Locations

US (1)