Trial Outcomes & Findings for Lifestyle Intervention for Young Adults With Serious Mental Illness (NCT NCT02815813)
NCT ID: NCT02815813
Last Updated: 2025-01-14
Results Overview
Participants' weight will be measured in pounds (lbs.) on a flat, even surface with the use of a high-quality, calibrated professional medical scale, with the participant wearing indoor clothing and no shoes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline, 6 months, and 12 months
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
PeerFIT
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
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BEAT
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
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|---|---|---|
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Overall Study
STARTED
|
76
|
74
|
|
Overall Study
COMPLETED
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifestyle Intervention for Young Adults With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
PeerFIT
n=76 Participants
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
|
BEAT
n=74 Participants
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
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Total
n=150 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
28.2 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
28.4 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
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Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
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18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
74 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: Participants at baseline, 6 months and 12 months
Participants' weight will be measured in pounds (lbs.) on a flat, even surface with the use of a high-quality, calibrated professional medical scale, with the participant wearing indoor clothing and no shoes.
Outcome measures
| Measure |
PeerFIT
n=76 Participants
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
|
BEAT
n=74 Participants
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
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|---|---|---|
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Weight
Baseline weight
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107.6 Kilogram
Standard Deviation 26.9
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105.1 Kilogram
Standard Deviation 20.9
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Weight
6-month weight
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109.7 Kilogram
Standard Deviation 26.3
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106.7 Kilogram
Standard Deviation 22.1
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Weight
12-month weight
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109.2 Kilogram
Standard Deviation 27.6
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106.9 Kilogram
Standard Deviation 22.5
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PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsAfter a baseline blood pressure has been obtained, participants are asked to walk a measured distance as far as they are able in 6 minutes.
Outcome measures
| Measure |
PeerFIT
n=76 Participants
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
|
BEAT
n=74 Participants
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
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|---|---|---|
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6-minute Walk Test
Baseline
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1398 feet
Standard Deviation 296
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1424 feet
Standard Deviation 250
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6-minute Walk Test
6-months
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1386 feet
Standard Deviation 296
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1426 feet
Standard Deviation 248
|
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6-minute Walk Test
12-months
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1357 feet
Standard Deviation 271
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1319 feet
Standard Deviation 332
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SECONDARY outcome
Timeframe: Six months and 12 monthsPopulation: Data analyzed at 6 months for both PeerFIT and BEAT arms.
The Self-efficacy for Exercise Behaviors (SEB) scale was used to measure participants' self-efficacy related to the ability to exercise despite common barriers. Five items represent the following areas: negative affect, resisting relapse, and making time for exercise. Respondents rate their confidence on a five-point Likert scale from 1 = "I know I cannot" to 4 = "I know I can". Total scores range from 5 to 20. Higher overall scores indicate higher exercise self efficacy.
Outcome measures
| Measure |
PeerFIT
n=54 Participants
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
|
BEAT
n=49 Participants
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
|
|---|---|---|
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Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
6 months
|
11 score on a scale
Standard Deviation 3.4
|
10.7 score on a scale
Standard Deviation 4.3
|
|
Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
12 months
|
11.2 score on a scale
Standard Deviation 3.5
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10.2 score on a scale
Standard Deviation 3.4
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SECONDARY outcome
Timeframe: Six months and 12 monthsPopulation: Data was collected on SPS for the PeerFIT group only at 6 and 12 months.
Participants' level of perceived peer support was measured with the Social Provisions Scale (SPS). The SPS consists of 10 questions items assessing an individual's perceived social support across different dimensions like attachment, guidance, social integration, reliable alliance, and reassurance of worth; essentially assessing how much support they feel they receive from their social network. The items are rated on a 4-point Likert scale from 1 ("strongly disagree) to 4 ("strongly agree") as it pertains to relationships with group members. Scores range from 10 to 40. Higher scores indicate greater perceived support from group relationships.
Outcome measures
| Measure |
PeerFIT
n=47 Participants
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
|
BEAT
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
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|---|---|---|
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Social Provisions Scale (SPS)
6 months
|
29.2 score on a scale
Standard Deviation 5.2
|
—
|
|
Social Provisions Scale (SPS)
12 months
|
27.1 score on a scale
Standard Deviation 5.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: Analyzed at baseline, 6 and 12 months
Hemoglobin A1C will be measured using the CardioChek PA Analyzer.
Outcome measures
| Measure |
PeerFIT
n=76 Participants
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
|
BEAT
n=74 Participants
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
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|---|---|---|
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Hemoglobin A1C
6 months
|
5.3 Percentage of HbA1c
Standard Deviation 0.7
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5.3 Percentage of HbA1c
Standard Deviation 0.6
|
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Hemoglobin A1C
12 months
|
5.6 Percentage of HbA1c
Standard Deviation 1.4
|
5.5 Percentage of HbA1c
Standard Deviation 0.7
|
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Hemoglobin A1C
Baseline
|
5.3 Percentage of HbA1c
Standard Deviation 0.8
|
5.3 Percentage of HbA1c
Standard Deviation 1.0
|
Adverse Events
PeerFIT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BEAT
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