Smoking Cessation, Obesity
Conditions
Keywords
smoking, smoking cessation, smoking treatment, quitting smoking, obesity, overweight, multiple health behavior change intervention
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.
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
Interventions
BEHAVIORALSelf-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.
BEHAVIORALHealthy 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.
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will not know condition assignment
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 7-day Point-prevalence Abstinence From Smoking | 2 months post-quit (end of treatment) | The number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking |
| Treatment Attendance | 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 |
| Weight Change | change in weight from baseline to 2 months post-quit (end of treatment) | body weight (lbs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 7-day Point-prevalence Abstinence From Smoking | 1 months post-quit (end of treatment) | Number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking |
| Number of Cigarettes Smoked/Day | 2 months post-quit (end of treatment) | Timeline Follow Back (TLFB) interview will assess self-reported number of cigarettes smoked each day, summed over past 28 days |
| Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked | 2 months post-quit (end of treatment) | 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. |
| Duration of Longest Period of Abstinence From Smoking | 2 months post-quit (end of treatment) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Delay Discounting | week 9 (quit day) | The Monetary Choice Questionnaire will be used to determine a person's rate of impulsive choices when asked to choose between hypothetical amounts of money. Participants will choose between (hypothetical) smaller amounts of money available today or larger amounts of money available following a delay. Responses on this questionnaire are used to determine a person's discount rate, symbolized by the parameter k, which refers to how steeply delay reduces the value of a reward. Higher k values indicate greater impulsivity (i.e., a greater preference for smaller rewards available immediately than larger rewards available after a delay). |
| Self-efficacy for Weight Management After Quitting Smoking | week 9 (quit day) | The Weight-Efficacy After Quitting scale will be used to compare baseline to quit day. Scores range from 6 to 60; higher scores indicate a better outcome. |
| Study Retention | 3 months post-quit (end of study) | The percentage of participants completing the final outcome assessment will be used to determine study retention. |
| Negative Affect Score | week 9 (quit day) | Negative affect (i.e., negative emotional states) will be assessed using a measure called the Positive and Negative Affective Schedule (PANAS). This measure is used to derive a Negative Affect Score. This score is the sum of all items assessing negative affect. The Negative Affect Score can range from 10-50. Higher scores represent more negative affect. |
| Treatment Satisfaction | week 9 (quit day) | Treatment satisfaction during the first half of treatment will be assessed via a questionnaire, with higher scores (1-5) indicating greater satisfaction. |
| Self-efficacy for Quitting Smoking | week 9 (quit day) | The Smoking Self-Efficacy Questionnaire will be used to compare baseline to quit day. Scores range from 12 to 60; higher scores indicate a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self-Regulation Strategies + Large Changes (SR) Self-Regulation strategies + large changes (SR) arm Weeks 1-8 of the 16-week program will include weekly group sessions focused on teaching self-regulation and efforts to produce weight loss to buffer against anticipated post-cessation weight gain. Participants will be taught the core self-regulation skills for controlling their weight. 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 weight changes have occurred.
Smoking Cessation Treatment: 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 study arms. In preparation of quitting, nicotine replacement 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. | 27 |
| Healthy Lifestyle Education (LE) This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment
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.
Smoking Cessation Treatment: 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. | 28 |
| Total | 55 |
Baseline characteristics
| Characteristic | Self-Regulation Strategies + Large Changes (SR) | Healthy Lifestyle Education (LE) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 23 Participants | 48 Participants |
| Age, Continuous | 50.0 years STANDARD_DEVIATION 10.7 | 51.3 years STANDARD_DEVIATION 11.7 | 50.6 years STANDARD_DEVIATION 11.2 |
| Cigarettes smoked per day | 14.6 cigarettes per day STANDARD_DEVIATION 5.8 | 14.1 cigarettes per day STANDARD_DEVIATION 6.7 | 14.4 cigarettes per day STANDARD_DEVIATION 6.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 16 Participants | 36 Participants |
| Region of Enrollment United States | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Female | 19 Participants | 25 Participants | 44 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 27 | 0 / 28 |
Outcome results
Primary
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
Time frame: 2 months post-quit (end of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Number of Participants With 7-day Point-prevalence Abstinence From Smoking | 11 Participants |
| Healthy Lifestyle Education (LE) | Number of Participants With 7-day Point-prevalence Abstinence From Smoking | 13 Participants |
Primary
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
Time frame: Treatment weeks 1-10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Treatment Attendance | 85.2 percentage of sessions | Standard Deviation 26.1 |
| Healthy Lifestyle Education (LE) | Treatment Attendance | 90.7 percentage of sessions | Standard Deviation 17.2 |
Primary
Weight Change
body weight (lbs)
Time frame: change in weight from baseline to 2 months post-quit (end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Weight Change | -5.3 pounds | Standard Deviation 9.4 |
| Healthy Lifestyle Education (LE) | Weight Change | .03 pounds | Standard Deviation 9.8 |
Secondary
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.
Time frame: 2 months post-quit (end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Duration of Longest Period of Abstinence From Smoking | 29.1 days | Standard Deviation 22 |
| Healthy Lifestyle Education (LE) | Duration of Longest Period of Abstinence From Smoking | 40.5 days | Standard Deviation 17.5 |
Secondary
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
Time frame: 2 months post-quit (end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Number of Cigarettes Smoked/Day | 1.9 cigarettes per day | Standard Deviation 3.4 |
| Healthy Lifestyle Education (LE) | Number of Cigarettes Smoked/Day | 1.6 cigarettes per day | Standard Deviation 3.2 |
Secondary
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.
Time frame: 2 months post-quit (end of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked | 24 Participants |
| Healthy Lifestyle Education (LE) | Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked | 26 Participants |
Secondary
Number of Participants With 7-day Point-prevalence Abstinence From Smoking
Number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Time frame: 1 months post-quit (end of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Number of Participants With 7-day Point-prevalence Abstinence From Smoking | 13 Participants |
| Healthy Lifestyle Education (LE) | Number of Participants With 7-day Point-prevalence Abstinence From Smoking | 13 Participants |
Other Pre-specified
Delay Discounting
The Monetary Choice Questionnaire will be used to determine a person's rate of impulsive choices when asked to choose between hypothetical amounts of money. Participants will choose between (hypothetical) smaller amounts of money available today or larger amounts of money available following a delay. Responses on this questionnaire are used to determine a person's discount rate, symbolized by the parameter k, which refers to how steeply delay reduces the value of a reward. Higher k values indicate greater impulsivity (i.e., a greater preference for smaller rewards available immediately than larger rewards available after a delay).
Time frame: week 9 (quit day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Delay Discounting | .037 k value | Standard Deviation 0.06 |
| Healthy Lifestyle Education (LE) | Delay Discounting | .032 k value | Standard Deviation 0.07 |
Other Pre-specified
Negative Affect Score
Negative affect (i.e., negative emotional states) will be assessed using a measure called the Positive and Negative Affective Schedule (PANAS). This measure is used to derive a Negative Affect Score. This score is the sum of all items assessing negative affect. The Negative Affect Score can range from 10-50. Higher scores represent more negative affect.
Time frame: week 9 (quit day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Negative Affect Score | 17.4 score on a scale | Standard Deviation 8.9 |
| Healthy Lifestyle Education (LE) | Negative Affect Score | 19.3 score on a scale | Standard Deviation 8 |
Other Pre-specified
Self-efficacy for Quitting Smoking
The Smoking Self-Efficacy Questionnaire will be used to compare baseline to quit day. Scores range from 12 to 60; higher scores indicate a better outcome.
Time frame: week 9 (quit day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Self-efficacy for Quitting Smoking | 45.0 score on a scale | Standard Deviation 10.9 |
| Healthy Lifestyle Education (LE) | Self-efficacy for Quitting Smoking | 45.7 score on a scale | Standard Deviation 8.3 |
Other Pre-specified
Self-efficacy for Weight Management After Quitting Smoking
The Weight-Efficacy After Quitting scale will be used to compare baseline to quit day. Scores range from 6 to 60; higher scores indicate a better outcome.
Time frame: week 9 (quit day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Self-efficacy for Weight Management After Quitting Smoking | 7.1 score on a scale of self-efficacy | Standard Deviation 1.4 |
| Healthy Lifestyle Education (LE) | Self-efficacy for Weight Management After Quitting Smoking | 6.4 score on a scale of self-efficacy | Standard Deviation 1.7 |
Other Pre-specified
Study Retention
The percentage of participants completing the final outcome assessment will be used to determine study retention.
Time frame: 3 months post-quit (end of study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Study Retention | 25 Participants |
| Healthy Lifestyle Education (LE) | Study Retention | 27 Participants |
Other Pre-specified
Treatment Satisfaction
Treatment satisfaction during the first half of treatment will be assessed via a questionnaire, with higher scores (1-5) indicating greater satisfaction.
Time frame: week 9 (quit day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Regulation Strategies + Large Changes (SR) | Treatment Satisfaction | 4.5 score on a scale | Standard Deviation 0.91 |
| Healthy Lifestyle Education (LE) | Treatment Satisfaction | 4.7 score on a scale | Standard Deviation 0.54 |