Smoking CessationNCT05136430
A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
A study testing Self-Regulation strategies + large changes (SR), Healthy Lifestyle Education (LE) and Smoking Cessation Treatment in people with Smoking Cessation and Obesity, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Obesity
- What is being tested?
- Self-Regulation strategies + large changes (SR), Healthy Lifestyle Education (LE) and Smoking Cessation Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 10 Jan 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- not stabilized on psychotropic medications
- current use of medications known to interact with smoking cessation
- clinically significant medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
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.
Read the detailed 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
- Conditions
- Smoking Cessation, Obesity
- Being tested
- Self-Regulation strategies + large changes (SR), Healthy Lifestyle Education (LE), Smoking Cessation Treatment
- Keywords
- smoking, smoking cessation, smoking treatment, quitting smoking, obesity, overweight, multiple health behavior change intervention
- Medical subject headings
- Smoking Cessation, Obesity, Smoking, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Regulation strategies + large changes (SR)Behavioural
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)Behavioural
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.
Smoking Cessation TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Regulation strategies + large changes (SR) | Experimental | This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment Receives: 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 Receives: Behavioral: Healthy Lifestyle Education (LE); Other: Smoking Cessation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months post-quit (end of treatment)
Weight Change
body weight (lbs)
Measured: 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
Measured: Treatment weeks 1-10
Secondary outcomes (4)
Number of Participants With 7-day Point-prevalence Abstinence From Smoking
Number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Measured: 1 months post-quit (end of treatment)
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
Measured: 2 months post-quit (end of treatment)
Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked
The number of participants for whom the number of cigarettes smoked per day in the past 7 days has decreased by ≥50%, relative to the number of cigarettes the participant smoked per day at baseline.
Measured: 2 months post-quit (end of treatment)
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.
Measured: 2 months post-quit (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Nov 2021
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
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.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Cara Murphy, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136430
- Sponsor's protocol ID
- 1608001567
- Other IDs
- K23DA045078
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2021
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
- ClinicalTrials.gov ID
- NCT05136430
- Acronym / sponsor ID
- 1608001567
- Conditions
- Smoking Cessation, Obesity
- Keywords
- smoking, smoking cessation, smoking treatment, quitting smoking, obesity, overweight, multiple health behavior change intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-Regulation strategies + large changes (SR) | Experimental | Behavioral: Self-Regulation strategies + large changes (SR), Other: Smoking Cessation TreatmentThis arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment |
| Healthy Lifestyle Education (LE) | Active comparator | Behavioral: Healthy Lifestyle Education (LE), Other: Smoking Cessation TreatmentThis arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | Self-Regulation strategies + large changes (SR) |
| 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. | Behavioural | Healthy Lifestyle Education (LE) |
| Smoking Cessation TreatmentThe 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. | Other | Healthy Lifestyle Education (LE), Self-Regulation strategies + large changes (SR) |
Primary outcome
Number of Participants With 7-day Point-prevalence Abstinence From Smoking
Time frame: 2 months post-quit (end of treatment)
The number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Weight Change
Time frame: change in weight from baseline to 2 months post-quit (end of treatment)
body weight (lbs)
Treatment Attendance
Time frame: Treatment weeks 1-10
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
4 secondary outcomes
Number of Participants With 7-day Point-prevalence Abstinence From Smoking
Time frame: 1 months post-quit (end of treatment)
Number of Cigarettes Smoked/Day
Time frame: 2 months post-quit (end of treatment)
Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked
Time frame: 2 months post-quit (end of treatment)
Duration of Longest Period of Abstinence From Smoking
Time frame: 2 months post-quit (end of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Regulation strategies + large changes (SR), Healthy Lifestyle Education (LE) and Smoking Cessation Treatment in people with Smoking Cessation and Obesity, run by Brown University 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 6 inclusion and 9 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 9 May 2025. 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 9 May 2025). 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?
Number of Participants With 7-day Point-prevalence Abstinence From Smoking (time frame: 2 months post-quit (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2025.