Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

NCT03156660 | Completed Results DMC

• 2 other identifiers: 16-04522-FBR01DK107747
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Change, Body; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Weight

  At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes.

  12 months from randomization

• Point Prevalence Tobacco Abstinence

  Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.

  12 months from randomization

Study Arms (3)

Weight gain prevention (Group 1)

EXPERIMENTAL

Small Changes weight stability intervention

Behavioral: Weight gain prevention (Group 1)

Weight loss intervention (Group 2)

EXPERIMENTAL

Look AHEAD weight loss intervention

Behavioral: Weight loss intervention (Group 2)

Self-guided intervention (Group 3)

ACTIVE COMPARATOR

Self-guided weight management with the EatingWell Diet book

Behavioral: Self-guided intervention (Group 3)

Interventions

Weight gain prevention (Group 1) BEHAVIORAL

Participants will be asked to keep their weight stable during the initial 8 weeks of the study. Intervention Components: 1. 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). 2. Daily self-monitoring of steps and number of Small Changes 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Fit Bit Alta activity trackers to self-monitor steps

Weight gain prevention (Group 1)

Weight loss intervention (Group 2) BEHAVIORAL

Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8. Intervention Components: 1. Tailored calorie and fat goals based on their baseline weight. 2. Daily dietary intake and physical activity self-monitoring using a website or app. 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention 5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions 6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day 7. Fit Bit Alta activity trackers to self-monitor steps

Weight loss intervention (Group 2)

Self-guided intervention (Group 3) BEHAVIORAL

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: 1. EatingWell Diet book. 2. Daily weight self-monitoring on the BodyTraceTM e-scale

Self-guided intervention (Group 3)

Eligibility Criteria

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

You may qualify if:

• 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 \< 150/95 and a heart rate of \>40 beats per minute and \<120 beats per minute.

You may not qualify if:

• Participants must not have a known contraindication, allergy or hypersensitivity to varenicline therapy
• Participants must not currently (in the previous 30 days) be participating in other behavioral or pharmacologic weight or smoking cessation interventions
• Participants must not have had weight loss surgery (hx of gastric bypass, stomach stapling or banding)
• Participants must not have lost \> 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

Sponsors & Collaborators

• University of Tennessee: lead
• Mayo Clinic: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

Related Publications (2)

• Pebley K, Bursac Z, Klesges RC, Ebbert JO, Womack CR, Graber J, Little MA, Derefinko KJ, Krukowski RA. A randomized controlled trial to reduce post-cessation weight gain. Int J Obes (Lond). 2023 Jun;47(6):471-478. doi: 10.1038/s41366-023-01286-5. Epub 2023 Feb 25.

  PMID: 36841886 DERIVED

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

MeSH Terms

Conditions

Body Weight Changes; Smoking Cessation

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Rebecca Krukowski
• Organization: University of Virginia

wae4mq@virginia.edu

4349245303

Study Officials

• Rebecca Krukowski, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 17, 2017
• Study Start: November 30, 2017
• Primary Completion: March 12, 2022
• Study Completion: March 12, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Two years following the termination of the study
• Access Criteria: Upon reasonable request to the principal investigator, Rebecca Krukowski

Locations

US (1)