Trial Outcomes & Findings for A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers (NCT NCT05136430)
NCT ID: NCT05136430
Last Updated: 2025-05-09
Results Overview
The number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
2 months post-quit (end of treatment)
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers
Baseline characteristics by cohort
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=27 Participants
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.
|
Healthy Lifestyle Education (LE)
n=28 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Cigarettes smoked per day
|
14.6 cigarettes per day
STANDARD_DEVIATION 5.8 • n=5 Participants
|
14.1 cigarettes per day
STANDARD_DEVIATION 6.7 • n=7 Participants
|
14.4 cigarettes per day
STANDARD_DEVIATION 6.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 months post-quit (end of treatment)The number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=25 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Number of Participants With 7-day Point-prevalence Abstinence From Smoking
|
11 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: change in weight from baseline to 2 months post-quit (end of treatment)body weight (lbs)
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=25 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Weight Change
|
-5.3 pounds
Standard Deviation 9.4
|
.03 pounds
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: Treatment weeks 1-10The 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
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=27 Participants
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.
|
Healthy Lifestyle Education (LE)
n=28 Participants
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.
|
|---|---|---|
|
Treatment Attendance
|
85.2 percentage of sessions
Standard Deviation 26.1
|
90.7 percentage of sessions
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 1 months post-quit (end of treatment)Number of participants with biochemically-verified 7-day-point prevalence abstinence from smoking
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=26 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Number of Participants With 7-day Point-prevalence Abstinence From Smoking
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=25 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Number of Cigarettes Smoked/Day
|
1.9 cigarettes per day
Standard Deviation 3.4
|
1.6 cigarettes per day
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=25 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Number of Participants Achieving ≥50% Reduction in Cigarettes Per Day Smoked
|
24 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=25 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Duration of Longest Period of Abstinence From Smoking
|
29.1 days
Standard Deviation 22.0
|
40.5 days
Standard Deviation 17.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=26 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Self-efficacy for Quitting Smoking
|
45.0 score on a scale
Standard Deviation 10.9
|
45.7 score on a scale
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post-quit (end of study)The percentage of participants completing the final outcome assessment will be used to determine study retention.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=27 Participants
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.
|
Healthy Lifestyle Education (LE)
n=28 Participants
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.
|
|---|---|---|
|
Study Retention
|
25 Participants
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=26 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Self-efficacy for Weight Management After Quitting Smoking
|
7.1 score on a scale of self-efficacy
Standard Deviation 1.4
|
6.4 score on a scale of self-efficacy
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=26 Participants
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.
|
Healthy Lifestyle Education (LE)
n=26 Participants
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.
|
|---|---|---|
|
Delay Discounting
|
.037 k value
Standard Deviation .06
|
.032 k value
Standard Deviation .07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=26 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Negative Affect Score
|
17.4 score on a scale
Standard Deviation 8.9
|
19.3 score on a scale
Standard Deviation 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Self-Regulation Strategies + Large Changes (SR)
n=26 Participants
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.
|
Healthy Lifestyle Education (LE)
n=27 Participants
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.
|
|---|---|---|
|
Treatment Satisfaction
|
4.5 score on a scale
Standard Deviation .91
|
4.7 score on a scale
Standard Deviation .54
|
Adverse Events
Self-Regulation Strategies + Large Changes (SR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Lifestyle Education (LE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place