Weight Change, BodyNCT03156660
Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
A study testing Weight gain prevention (Group 1), Weight loss intervention (Group 2) and Self-guided intervention (Group 3) in people with Weight Change, Body and Smoking Cessation, run by University of Tennessee at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Change, Body, Smoking Cessation
- What is being tested?
- Weight gain prevention (Group 1), Weight loss intervention (Group 2) and Self-guided intervention (Group 3)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 12 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Weight Change, Body, Smoking Cessation
- Being tested
- Weight gain prevention (Group 1), Weight loss intervention (Group 2), Self-guided intervention (Group 3)
- Medical subject headings
- Body Weight Changes, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight gain prevention (Group 1)Behavioural
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
Weight loss intervention (Group 2)Behavioural
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
Self-guided intervention (Group 3)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Weight gain prevention (Group 1) | Experimental | Small Changes weight stability intervention Receives: Behavioral: Weight gain prevention (Group 1) |
| Weight loss intervention (Group 2) | Experimental | Look AHEAD weight loss intervention Receives: Behavioral: Weight loss intervention (Group 2) |
| Self-guided intervention (Group 3) | Active comparator | Self-guided weight management with the EatingWell Diet book Receives: Behavioral: Self-guided intervention (Group 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start30 Nov 2017
- Primary completion12 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Weight Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Krukowski, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156660
- Sponsor's protocol ID
- 16-04522-FB
- Other IDs
- R01DK107747
- Status last verified
- Apr 2022
- First submitted
- 12 May 2017
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Oswald M, Shahbazian A, Ross KM, You W, Krukowski RA. An Exploratory Analysis of Patterns of Weight Change in a Post-Cessation Weight Management Trial. Nicotine Tob Res. 2026 Feb 24;28(3):481-488. doi: 10.1093/ntr/ntaf108.
PubMed 40401536Toyon A, Bursac Z, Werner N, Krukowski RA. Impact of Weight Concern on Post-Cessation Weight Management, Smoking Cessation, and Program Engagement. Am J Health Promot. 2024 Jul;38(6):797-808. doi: 10.1177/08901171241234136. Epub 2024 Feb 14.
PubMed 38356272Pebley 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.
PubMed 36841886Hartmann-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.
PubMed 34611902
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
- ClinicalTrials.gov ID
- NCT03156660
- Acronym / sponsor ID
- 16-04522-FB
- Conditions
- Weight Change, Body, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight gain prevention (Group 1) | Experimental | Behavioral: Weight gain prevention (Group 1)Small Changes weight stability intervention |
| Weight loss intervention (Group 2) | Experimental | Behavioral: Weight loss intervention (Group 2)Look AHEAD weight loss intervention |
| Self-guided intervention (Group 3) | Active comparator | Behavioral: Self-guided intervention (Group 3)Self-guided weight management with the EatingWell Diet book |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight gain prevention (Group 1)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 | Behavioural | Weight gain prevention (Group 1) |
| Weight loss intervention (Group 2)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 | Behavioural | Weight loss intervention (Group 2) |
| Self-guided intervention (Group 3)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 | Behavioural | Self-guided intervention (Group 3) |
Primary outcome
Weight
Time frame: 12 months from randomization
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
Time frame: 12 months from randomization
Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40401536Oswald M, Shahbazian A, Ross KM, You W, Krukowski RA. An Exploratory Analysis of Patterns of Weight Change in a Post-Cessation Weight Management Trial. Nicotine Tob Res. 2026 Feb 24;28(3):481-488. doi: 10.1093/ntr/ntaf108.
- Derived from this study: PubMed 38356272Toyon A, Bursac Z, Werner N, Krukowski RA. Impact of Weight Concern on Post-Cessation Weight Management, Smoking Cessation, and Program Engagement. Am J Health Promot. 2024 Jul;38(6):797-808. doi: 10.1177/08901171241234136. Epub 2024 Feb 14.
- Derived from this study: PubMed 36841886Pebley 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.
- Derived from this study: PubMed 34611902Hartmann-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Krukowski, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight gain prevention (Group 1), Weight loss intervention (Group 2) and Self-guided intervention (Group 3) in people with Weight Change, Body and Smoking Cessation, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 months from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156660, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.