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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA045078 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Regulation strategies + large changes (SR) | Experimental | This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment |
|
| Healthy Lifestyle Education (LE) | Active Comparator | This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Regulation strategies + large changes (SR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 months post-quit (end of treatment) |
| Weight Change | body weight (lbs) | 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 | Treatment weeks 1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 7-day Point-prevalence Abstinence From Smoking | Number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking | 1 months post-quit (end of treatment) |
| Number of Cigarettes Smoked/Day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 9 (quit day) |
| Study Retention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02912 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 2 months post-quit (end of treatment) |
|
from enrollment until end of follow-up, approximately 21 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cara M. Murphy, Ph.D. | Brown University | 4018636519 | murphybrownlab@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2021 | Apr 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D009765 | Obesity |
| D012907 | Smoking |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
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Outcome assessor will not know condition assignment
|
| Healthy Lifestyle Education (LE) | Behavioral | 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 | Other | 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. |
|
Timeline Follow Back (TLFB) interview will assess self-reported number of cigarettes smoked each day, summed over past 28 days
| 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. | 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. | 2 months post-quit (end of treatment) |
The percentage of participants completing the final outcome assessment will be used to determine study retention.
| 3 months post-quit (end of study) |
| 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. | week 9 (quit day) |
| 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). | week 9 (quit day) |
| 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. | week 9 (quit day) |
| Treatment Satisfaction | Treatment satisfaction during the first half of treatment will be assessed via a questionnaire, with higher scores (1-5) indicating greater satisfaction. | week 9 (quit day) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | region of enrollment (country) | Count of Participants | Participants |
|
| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes per day |
|
| OG001 | 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. |
|
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| Primary | Weight Change | body weight (lbs) | Posted | Mean | Standard Deviation | pounds | change in weight from baseline to 2 months post-quit (end of treatment) |
|
|
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| 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 | Posted | Mean | Standard Deviation | percentage of sessions | Treatment weeks 1-10 |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 months post-quit (end of treatment) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | cigarettes per day | 2 months post-quit (end of treatment) |
|
|
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| 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. | Posted | Count of Participants | Participants | 2 months post-quit (end of treatment) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | days | 2 months post-quit (end of treatment) |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | week 9 (quit day) |
|
|
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| Other Pre-specified | Study Retention | The percentage of participants completing the final outcome assessment will be used to determine study retention. | Posted | Count of Participants | Participants | 3 months post-quit (end of study) |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale of self-efficacy | week 9 (quit day) |
|
|
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| 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). | Posted | Mean | Standard Deviation | k value | week 9 (quit day) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | week 9 (quit day) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | week 9 (quit day) |
|
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|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |