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Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

Primary Purpose

Weight Change, Body, Smoking Cessation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Weight gain prevention (Group 1)

Weight loss intervention (Group 2)

Self-guided intervention (Group 3)

About this trial

This is an interventional treatment trial for Weight Change, Body

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Weight gain prevention (Group 1)

Weight loss intervention (Group 2)

Self-guided intervention (Group 3)

Arm Description

Small Changes weight stability intervention

Look AHEAD weight loss intervention

Self-guided weight management with the EatingWell Diet book

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03156660

First Posted

May 12, 2017

Last Updated

April 19, 2023

Sponsor

University of Tennessee

Collaborators

Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03156660

Brief Title

Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

Official Title

Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

November 30, 2017 (Actual)

Primary Completion Date

March 12, 2022 (Actual)

Study Completion Date

March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Tennessee

Collaborators

Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

While smoking cessation leads to significant improvements in mortality and morbidity, weight gain post-cessation partially attenuates this benefit. Furthermore, concerns about postcessation weight gain are common and are often cited as a reason to delay cessation attempts. In addition, postcessation weight gain is associated with smoking relapse. Thus, although the health benefits of smoking cessation outweigh the negative impact of weight gain, ideally there would be intervention "packages" that would not require that people choose between smoking cessation and nontrivial weight gain. Thus, in the proposed study, the investigators will determine whether two very promising methods of reducing postcessation weight gain, namely a weight stability intervention (based on the evidence-based Small Changes intervention) versus a weight loss intervention (based on the evidence-based Look AHEAD intensive lifestyle intervention) followed by a smoking cessation intervention are efficacious for reducing postcessation weight gain. The investigators will randomize 400 smokers to one of three arms: a) a weight stability intervention prior to cessation (Group 1); b) a weight loss intervention prior to cessation (Group 2), or c) a self-guided intervention prior to cessation (Group 3) and to determine the efficacy of the interventions on preventing weight gain at 12 month follow-up. All three conditions receive a highly efficacious in-person smoking cessation behavioral intervention and six months of Varenicline (ChantixTM) pharmacotherapy. Those participants randomized to the Group 1 and Group 2 conditions will receive monthly booster weight management sessions, after completing the behavioral smoking cessation intervention. The primary outcomes will be weight change and smoking cessation at 12 month follow-up. In addition, the investigators will gather process data on mediators of treatment outcome via measures of treatment engagement (e.g., session attendance, varenicline utilization). The investigators will be able to determine whether a weight stability intervention or a weight loss intervention is efficacious in reducing post-cessation weight gain. The intervention results, if successful, could be disseminated and make a significant contribution towards curtailing obesity in this vulnerable population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Change, Body, Smoking Cessation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

305 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight gain prevention (Group 1)

Arm Type

Experimental

Arm Description

Small Changes weight stability intervention

Arm Title

Weight loss intervention (Group 2)

Arm Type

Experimental

Arm Description

Look AHEAD weight loss intervention

Arm Title

Self-guided intervention (Group 3)

Arm Type

Active Comparator

Arm Description

Self-guided weight management with the EatingWell Diet book

Intervention Type

Behavioral

Intervention Name(s)

Weight gain prevention (Group 1)

Intervention Description

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-monitor steps

Intervention Type

Behavioral

Intervention Name(s)

Weight loss intervention (Group 2)

Intervention Description

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 to achieve the study's calorie and fat goals and as a strategy to control portions Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day Fit Bit Alta activity trackers to self-monitor steps

Intervention Type

Behavioral

Intervention Name(s)

Self-guided intervention (Group 3)

Intervention Description

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

Primary Outcome Measure Information:

Title

Weight

Description

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.

Time Frame

12 months from randomization

Title

Point Prevalence Tobacco Abstinence

Description

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

Time Frame

12 months from randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Krukowski, PhD

Organizational Affiliation

University of Tennessee

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Tennessee Health Science Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

It is anticipated that a cleaned data set of study-specific data will be provided within two years following the termination of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data code book, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.

IPD Sharing Time Frame

Two years following the termination of the study

IPD Sharing Access Criteria

Upon reasonable request to the principal investigator, Rebecca Krukowski

Citations:

PubMed Identifier

34611902

Citation

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.

Results Reference

derived

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Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

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