Trial Outcomes & Findings for Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions (NCT NCT03156660)
NCT ID: NCT03156660
Last Updated: 2023-04-21
Results Overview
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
12 months from randomization
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Weight Gain Prevention (Group 1)
Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps
|
Weight Loss Intervention (Group 2)
Look AHEAD weight loss intervention
Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
Intervention Components:
1. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps
|
Self-guided Intervention (Group 3)
Self-guided weight management with the EatingWell Diet book
Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
Intervention Components:
1. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
110
|
86
|
|
Overall Study
COMPLETED
|
95
|
100
|
78
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
Baseline characteristics by cohort
| Measure |
Weight Gain Prevention (Group 1)
n=109 Participants
Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps
|
Weight Loss Intervention (Group 2)
n=110 Participants
Look AHEAD weight loss intervention
Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
Intervention Components:
1. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps
|
Self-guided Intervention (Group 3)
n=86 Participants
Self-guided weight management with the EatingWell Diet book
Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
Intervention Components:
1. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
55.5 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
54.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
207 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
299 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
132 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
159 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=99 Participants
|
110 participants
n=107 Participants
|
86 participants
n=206 Participants
|
305 participants
n=7 Participants
|
|
Baseline weight
|
92.5 kilograms
STANDARD_DEVIATION 21.6 • n=99 Participants
|
88.2 kilograms
STANDARD_DEVIATION 19.8 • n=107 Participants
|
89.7 kilograms
STANDARD_DEVIATION 19.9 • n=206 Participants
|
90.2 kilograms
STANDARD_DEVIATION 21.8 • n=7 Participants
|
|
Average number of cigarettes smoked per day
|
16.3 number of cigarettes
STANDARD_DEVIATION 8.3 • n=99 Participants
|
15.9 number of cigarettes
STANDARD_DEVIATION 8.4 • n=107 Participants
|
15.7 number of cigarettes
STANDARD_DEVIATION 8.8 • n=206 Participants
|
15.9 number of cigarettes
STANDARD_DEVIATION 8.5 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 months from randomizationAt all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes.
Outcome measures
| Measure |
Weight Gain Prevention (Group 1)
n=109 Participants
Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps
|
Weight Loss Intervention (Group 2)
n=110 Participants
Look AHEAD weight loss intervention
Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
Intervention Components:
1. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps
|
Self-guided Intervention (Group 3)
n=86 Participants
Self-guided weight management with the EatingWell Diet book
Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
Intervention Components:
1. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale
|
|---|---|---|---|
|
Weight
|
-0.24 kilograms
Standard Deviation 0.25
|
-1.11 kilograms
Standard Deviation 0.20
|
1.25 kilograms
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: 12 months from randomizationPopulation: Completers
Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.
Outcome measures
| Measure |
Weight Gain Prevention (Group 1)
n=95 Participants
Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps
|
Weight Loss Intervention (Group 2)
n=100 Participants
Look AHEAD weight loss intervention
Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
Intervention Components:
1. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps
|
Self-guided Intervention (Group 3)
n=80 Participants
Self-guided weight management with the EatingWell Diet book
Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
Intervention Components:
1. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale
|
|---|---|---|---|
|
Point Prevalence Tobacco Abstinence
|
39 Participants
|
49 Participants
|
41 Participants
|
Adverse Events
Weight Gain Prevention (Group 1)
Serious events: 17 serious events
Other events: 88 other events
Deaths: 1 deaths
Weight Loss Intervention (Group 2)
Serious events: 14 serious events
Other events: 84 other events
Deaths: 0 deaths
Self-guided Intervention (Group 3)
Serious events: 12 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weight Gain Prevention (Group 1)
n=109 participants at risk
Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps
|
Weight Loss Intervention (Group 2)
n=110 participants at risk
Look AHEAD weight loss intervention
Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
Intervention Components:
1. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps
|
Self-guided Intervention (Group 3)
n=86 participants at risk
Self-guided weight management with the EatingWell Diet book
Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
Intervention Components:
1. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale
|
|---|---|---|---|
|
Psychiatric disorders
Severe distress
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Cardiac disorders
Low blood pressure
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Cardiac disorders
Asystole
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 2 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Infections and infestations
Influenza
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Infections and infestations
Bloodstream Infection
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Nervous system disorders
Stroke
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Nervous system disorders
Seizure
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Nervous system disorders
Blockage in legs, stroke, surgery
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Injury, poisoning and procedural complications
Clavicle injury
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Injury, poisoning and procedural complications
Head Injury and amnesia
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Injury, poisoning and procedural complications
Ankle injury
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding and ulcer
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Ulcerative Colitis
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
General disorders
Dehydration and sinus infection
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
General disorders
Fever
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Gallbladder Surgery
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Bladder Surgery
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
1.8%
2/110 • Number of events 2 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Hysterectomy due to cervical cancer
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Knee Surgery
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Surgery for mass in large intestine
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Cerebral Spinal Fluid leak and surgery
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Biopsy
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Heart Surgery
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
1.8%
2/110 • Number of events 2 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Back Surgery
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Hip Surgery
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Foot Surgery
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.91%
1/110 • Number of events 1 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Prostate Surgery (cancer)
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Brain surgery (tumor)
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Surgical and medical procedures
Gastric Sleeve Surgery
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
1.2%
1/86 • Number of events 1 • 12 months
Consistent with the typical definition
|
|
Cardiac disorders
Hole in Heart
|
0.92%
1/109 • Number of events 1 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
Other adverse events
| Measure |
Weight Gain Prevention (Group 1)
n=109 participants at risk
Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps
|
Weight Loss Intervention (Group 2)
n=110 participants at risk
Look AHEAD weight loss intervention
Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
Intervention Components:
1. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps
|
Self-guided Intervention (Group 3)
n=86 participants at risk
Self-guided weight management with the EatingWell Diet book
Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
Intervention Components:
1. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale
|
|---|---|---|---|
|
Psychiatric disorders
Emotional Disturbance
|
5.5%
6/109 • Number of events 6 • 12 months
Consistent with the typical definition
|
5.5%
6/110 • Number of events 6 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Psychiatric disorders
Depression
|
24.8%
27/109 • Number of events 36 • 12 months
Consistent with the typical definition
|
22.7%
25/110 • Number of events 33 • 12 months
Consistent with the typical definition
|
33.7%
29/86 • Number of events 37 • 12 months
Consistent with the typical definition
|
|
Cardiac disorders
High Blood Pressure
|
16.5%
18/109 • Number of events 20 • 12 months
Consistent with the typical definition
|
21.8%
24/110 • Number of events 25 • 12 months
Consistent with the typical definition
|
12.8%
11/86 • Number of events 13 • 12 months
Consistent with the typical definition
|
|
General disorders
Difficulty Sleeping
|
16.5%
18/109 • Number of events 19 • 12 months
Consistent with the typical definition
|
20.9%
23/110 • Number of events 25 • 12 months
Consistent with the typical definition
|
29.1%
25/86 • Number of events 26 • 12 months
Consistent with the typical definition
|
|
General disorders
Abnormal Dreams
|
22.9%
25/109 • Number of events 25 • 12 months
Consistent with the typical definition
|
13.6%
15/110 • Number of events 15 • 12 months
Consistent with the typical definition
|
17.4%
15/86 • Number of events 17 • 12 months
Consistent with the typical definition
|
|
General disorders
Rapid Weight loss
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
9.1%
10/110 • Number of events 11 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
General disorders
Swelling
|
6.4%
7/109 • Number of events 8 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/109 • 12 months
Consistent with the typical definition
|
7.3%
8/110 • Number of events 8 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Nervous system disorders
Headache
|
11.0%
12/109 • Number of events 13 • 12 months
Consistent with the typical definition
|
13.6%
15/110 • Number of events 15 • 12 months
Consistent with the typical definition
|
8.1%
7/86 • Number of events 8 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Diarrhea
|
6.4%
7/109 • Number of events 7 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
8.3%
9/109 • Number of events 9 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Nausea
|
25.7%
28/109 • Number of events 32 • 12 months
Consistent with the typical definition
|
22.7%
25/110 • Number of events 26 • 12 months
Consistent with the typical definition
|
19.8%
17/86 • Number of events 17 • 12 months
Consistent with the typical definition
|
|
Gastrointestinal disorders
Constipation
|
5.5%
6/109 • Number of events 6 • 12 months
Consistent with the typical definition
|
5.5%
6/110 • Number of events 6 • 12 months
Consistent with the typical definition
|
5.8%
5/86 • Number of events 5 • 12 months
Consistent with the typical definition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
5.5%
6/109 • Number of events 6 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Infections and infestations
Cold
|
8.3%
9/109 • Number of events 12 • 12 months
Consistent with the typical definition
|
13.6%
15/110 • Number of events 17 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
|
Infections and infestations
Influenza
|
6.4%
7/109 • Number of events 7 • 12 months
Consistent with the typical definition
|
0.00%
0/110 • 12 months
Consistent with the typical definition
|
0.00%
0/86 • 12 months
Consistent with the typical definition
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place