Trial Outcomes & Findings for Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness (NCT NCT04560335)
NCT ID: NCT04560335
Last Updated: 2026-06-09
Results Overview
Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
Change from Baseline to 6 months
Results posted on
2026-06-09
Participant Flow
We included adult Veterans (age ≥18) who had a chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with or without psychosis; a BMI ≥ 30.0 (obese); owned an Android or iPhone. Exclusion criteria included being pregnant or nursing, inpatient psychiatric hospitalization within ≤30 days, history of bariatric surgery, medical record diagnosis of dementia, or having a conservator/legally authorized representative make their medical decisions.
Peer specialists, staff stakeholders, Veterans in local veteran groups, and/or national leadership were not considered enrolled.
Participant milestones
| Measure |
Coach to Fit
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
129
|
|
Overall Study
COMPLETED
|
93
|
85
|
|
Overall Study
NOT COMPLETED
|
35
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There was missing data for 7 participants in the CoachToFit group
Baseline characteristics by cohort
| Measure |
Coach to Fit
n=128 Participants
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
n=128 Participants
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 13.2 • n=128 Participants
|
53.8 years
STANDARD_DEVIATION 12.9 • n=128 Participants
|
53.5 years
STANDARD_DEVIATION 13.0 • n=256 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=128 Participants
|
38 Participants
n=128 Participants
|
80 Participants
n=256 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=128 Participants
|
90 Participants
n=128 Participants
|
176 Participants
n=256 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=128 Participants
|
0 Participants
n=128 Participants
|
1 Participants
n=256 Participants
|
|
Race/Ethnicity, Customized
Black
|
33 Participants
n=128 Participants
|
27 Participants
n=128 Participants
|
60 Participants
n=256 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=128 Participants
|
95 Participants
n=128 Participants
|
178 Participants
n=256 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
8 Participants
n=128 Participants
|
3 Participants
n=128 Participants
|
11 Participants
n=256 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=128 Participants
|
3 Participants
n=128 Participants
|
6 Participants
n=256 Participants
|
|
Region of Enrollment
United States
|
128 Participants
n=128 Participants
|
128 Participants
n=128 Participants
|
256 Participants
n=256 Participants
|
|
Diagnosis
Schizophrenia Disorder - any type
|
2 Participants
n=128 Participants
|
4 Participants
n=128 Participants
|
6 Participants
n=256 Participants
|
|
Diagnosis
Schizoaffective Disorder - any type
|
1 Participants
n=128 Participants
|
5 Participants
n=128 Participants
|
6 Participants
n=256 Participants
|
|
Diagnosis
Bipolar Disorder - any type
|
24 Participants
n=128 Participants
|
21 Participants
n=128 Participants
|
45 Participants
n=256 Participants
|
|
Diagnosis
Major Depressive Disorder without psychosis
|
101 Participants
n=128 Participants
|
98 Participants
n=128 Participants
|
199 Participants
n=256 Participants
|
|
Psychosis
|
8 Participants
n=128 Participants
|
17 Participants
n=128 Participants
|
25 Participants
n=256 Participants
|
|
Physical Activity
None (0 minutes)
|
15 Participants
n=121 Participants • There was missing data for 7 participants in the CoachToFit group
|
25 Participants
n=128 Participants • There was missing data for 7 participants in the CoachToFit group
|
40 Participants
n=249 Participants • There was missing data for 7 participants in the CoachToFit group
|
|
Physical Activity
Low (10, 20, 30 minutes)
|
66 Participants
n=121 Participants • There was missing data for 7 participants in the CoachToFit group
|
58 Participants
n=128 Participants • There was missing data for 7 participants in the CoachToFit group
|
124 Participants
n=249 Participants • There was missing data for 7 participants in the CoachToFit group
|
|
Physical Activity
Medium (40, 50, 60 minutes)
|
28 Participants
n=121 Participants • There was missing data for 7 participants in the CoachToFit group
|
32 Participants
n=128 Participants • There was missing data for 7 participants in the CoachToFit group
|
60 Participants
n=249 Participants • There was missing data for 7 participants in the CoachToFit group
|
|
Physical Activity
High (90, 120, 150+ minutes)
|
12 Participants
n=121 Participants • There was missing data for 7 participants in the CoachToFit group
|
13 Participants
n=128 Participants • There was missing data for 7 participants in the CoachToFit group
|
25 Participants
n=249 Participants • There was missing data for 7 participants in the CoachToFit group
|
|
Use of Weight Loss Treatment, past 6 months
GLP-1 medication in the past 6 months
|
16 Participants
n=128 Participants
|
17 Participants
n=128 Participants
|
33 Participants
n=256 Participants
|
|
Use of Weight Loss Treatment, past 6 months
MOVE! weight management program in the past 6 months
|
20 Participants
n=128 Participants
|
14 Participants
n=128 Participants
|
34 Participants
n=256 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: Analytic sample sizes varied. For weight, unadjusted analyses included 178 participants (93 CoachToFit, 85 Usual Care), while adjusted models included 173 participants (88 CoachToFit, 85 Usual Care) due to 5 missing baseline physical activity values.
Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.
Outcome measures
| Measure |
Coach to Fit
n=93 Participants
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
n=85 Participants
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
|---|---|---|
|
Body Weight. Mean Pounds
6 months
|
237.2 Pounds
Standard Deviation 46.5
|
246.7 Pounds
Standard Deviation 43.4
|
|
Body Weight. Mean Pounds
Baseline
|
244.3 Pounds
Standard Deviation 46.7
|
252.2 Pounds
Standard Deviation 45.8
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsNumber of Veterans who achieved 5% total weight loss at 6 months
Outcome measures
| Measure |
Coach to Fit
n=88 Participants
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
n=85 Participants
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
|---|---|---|
|
Body Weight. 5% Weight Loss
|
34 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsNumber of Veterans who achieved a 7% total weight loss by 6 months
Outcome measures
| Measure |
Coach to Fit
n=88 Participants
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
n=85 Participants
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
|---|---|---|
|
Body Weight. 7% Total Weight Loss
|
21 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Analytic sample sizes varied. For weight, unadjusted analyses included 178 participants (93 CoachToFit, 85 Usual Care), while adjusted models included 173 participants (88 CoachToFit, 85 Usual Care) due to 5 missing baseline physical activity values.
Change in mean BMI from baseline to 6 months
Outcome measures
| Measure |
Coach to Fit
n=93 Participants
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
n=85 Participants
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
|---|---|---|
|
BMI
Baseline
|
36.4 kg/m^2
Standard Deviation 5.4
|
37.0 kg/m^2
Standard Deviation 5.4
|
|
BMI
6 months
|
35.3 kg/m^2
Standard Deviation 5.5
|
36.5 kg/m^2
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: baseline to 6 monthsPopulation: This outcome had a different n due to missing data.
How many meters a person can walk in 6 minutes. More is better
Outcome measures
| Measure |
Coach to Fit
n=78 Participants
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly for six months.
|
Treatment as Usual
n=79 Participants
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule.
|
|---|---|---|
|
6 Minute Walk Test
Baseline
|
401.5 Meters walked in 6 minutes
Standard Deviation 96.7
|
391.7 Meters walked in 6 minutes
Standard Deviation 96.2
|
|
6 Minute Walk Test
6 months
|
415.2 Meters walked in 6 minutes
Standard Deviation 103.0
|
401.2 Meters walked in 6 minutes
Standard Deviation 104.6
|
Adverse Events
Coach to Fit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
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