Trial Outcomes & Findings for Weight Loss Treatment for Veterans With Binge Eating (NCT NCT03234881)
NCT ID: NCT03234881
Last Updated: 2025-07-09
Results Overview
The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials and has adequate convergence with the interview format. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. Score on a scale 0-6; higher=worse
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Results posted on
2025-07-09
Participant Flow
Participant milestones
| Measure |
MOVE!
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
53
|
|
Overall Study
COMPLETED
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
MOVE!
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
Baseline Characteristics
Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
Baseline characteristics by cohort
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 13.5 • n=56 Participants
|
57.9 years
STANDARD_DEVIATION 10.5 • n=53 Participants
|
55.8 years
STANDARD_DEVIATION 12.3 • n=109 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
11 Participants
n=56 Participants
|
16 Participants
n=53 Participants
|
27 Participants
n=109 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
45 Participants
n=56 Participants
|
36 Participants
n=53 Participants
|
81 Participants
n=109 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Other, not specified
|
0 Participants
n=56 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=109 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=56 Participants
|
5 Participants
n=53 Participants
|
13 Participants
n=109 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=56 Participants
|
48 Participants
n=53 Participants
|
96 Participants
n=109 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=55 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
1 Participants
n=53 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
1 Participants
n=108 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=55 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
6 Participants
n=53 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
11 Participants
n=108 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
|
Race/Ethnicity, Customized
More than one race/race not listed
|
3 Participants
n=55 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
2 Participants
n=53 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
5 Participants
n=108 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=55 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
44 Participants
n=53 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
91 Participants
n=108 Participants • Number analyzed is reflective of the number of participants that completed the assessment. Numbers differ from total number of participants since one participant chose not to answer this question.
|
|
Education
>High School/High School
|
7 Participants
n=56 Participants
|
12 Participants
n=53 Participants
|
19 Participants
n=109 Participants
|
|
Education
Some College
|
27 Participants
n=56 Participants
|
16 Participants
n=53 Participants
|
43 Participants
n=109 Participants
|
|
Education
Completed College
|
17 Participants
n=56 Participants
|
14 Participants
n=53 Participants
|
31 Participants
n=109 Participants
|
|
Education
Graduate School
|
5 Participants
n=56 Participants
|
11 Participants
n=53 Participants
|
16 Participants
n=109 Participants
|
|
Married
|
28 Participants
n=56 Participants
|
29 Participants
n=53 Participants
|
57 Participants
n=109 Participants
|
|
Weight History
Baseline Weight
|
258 lbs
STANDARD_DEVIATION 50.2 • n=56 Participants
|
249 lbs
STANDARD_DEVIATION 54.0 • n=53 Participants
|
254 lbs
STANDARD_DEVIATION 52.0 • n=109 Participants
|
|
Weight History
Highest Adult Weight
|
278 lbs
STANDARD_DEVIATION 52.9 • n=56 Participants
|
266 lbs
STANDARD_DEVIATION 55.4 • n=53 Participants
|
272 lbs
STANDARD_DEVIATION 54.2 • n=109 Participants
|
|
Weight History
Lowest Adult Weight
|
170 lbs
STANDARD_DEVIATION 33.6 • n=56 Participants
|
167 lbs
STANDARD_DEVIATION 37.1 • n=53 Participants
|
168 lbs
STANDARD_DEVIATION 35.2 • n=109 Participants
|
|
Mental Health
Trauma (Positive PCL Criteria A)
|
40 Participants
n=56 Participants
|
40 Participants
n=53 Participants
|
80 Participants
n=109 Participants
|
|
Mental Health
Alcohol Use Disorder (Positive AUDIT-C)
|
14 Participants
n=56 Participants
|
10 Participants
n=53 Participants
|
24 Participants
n=109 Participants
|
PRIMARY outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed for each timepoint is reflected below. Note some participants were lost to follow-up at each timepoint.
The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials and has adequate convergence with the interview format. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. Score on a scale 0-6; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
Baseline
|
3.18 score on a scale
Standard Error 0.16
|
2.89 score on a scale
Standard Error 0.19
|
|
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
3 Months
|
2.81 score on a scale
Standard Error 0.17
|
2.13 score on a scale
Standard Error 0.17
|
|
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
9 Months
|
2.57 score on a scale
Standard Error 0.16
|
2.00 score on a scale
Standard Error 0.19
|
|
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
15 Months
|
2.50 score on a scale
Standard Error 0.16
|
1.77 score on a scale
Standard Error 0.19
|
PRIMARY outcome
Timeframe: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed for each timepoint is reflected below. Note some participants were lost to follow-up at each timepoint.
The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency. Number of binges; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in Binge Episodes From Eating Disorder Examination Interview
Baseline
|
21.23 Number of binges
Standard Deviation 19.03
|
21.75 Number of binges
Standard Deviation 18.42
|
|
Change in Binge Episodes From Eating Disorder Examination Interview
3 Months
|
7.02 Number of binges
Standard Deviation 8.62
|
3.64 Number of binges
Standard Deviation 6.09
|
|
Change in Binge Episodes From Eating Disorder Examination Interview
9 Months
|
6.02 Number of binges
Standard Deviation 7.3
|
5.38 Number of binges
Standard Deviation 9.44
|
|
Change in Binge Episodes From Eating Disorder Examination Interview
15 Months
|
8.15 Number of binges
Standard Deviation 10.77
|
6.98 Number of binges
Standard Deviation 9.52
|
SECONDARY outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The PHQ-9 is a 9-item version, is a self-report measure for the symptoms of depression. Score on scale from 0-27; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
9.44 score on a scale
Standard Error 1.09
|
8.41 score on a scale
Standard Error 0.94
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
3 Months
|
7.89 score on a scale
Standard Error 5.19
|
5.38 score on a scale
Standard Error 0.73
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
9 Months
|
7.95 score on a scale
Standard Error 5.08
|
6.92 score on a scale
Standard Error 1.00
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
15 Months
|
7.47 score on a scale
Standard Error 0.91
|
7.97 score on a scale
Standard Error 5.04
|
SECONDARY outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD). Score on scale from 0-80; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in PTSD Checklist (PCL-5)
Baseline
|
37.48 score on a scale
Standard Error 3.76
|
31.27 score on a scale
Standard Error 4.11
|
|
Change in PTSD Checklist (PCL-5)
3 Months
|
27.67 score on a scale
Standard Error 2.85
|
22.62 score on a scale
Standard Error 3.00
|
|
Change in PTSD Checklist (PCL-5)
9 Months
|
29.29 score on a scale
Standard Error 3.36
|
28.46 score on a scale
Standard Error 3.60
|
|
Change in PTSD Checklist (PCL-5)
15 Months
|
27.05 score on a scale
Standard Error 3.57
|
23.85 score on a scale
Standard Error 3.67
|
SECONDARY outcome
Timeframe: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The WE-QoL is an 8-item self-report instrument for measurement of the impact weight and eating has on quality-of-life outcomes. Score on scale from 0-4; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Weight and Eating Quality of Life (WE-QoL)
3 Months
|
1.29 score on a scale
Standard Error 0.16
|
1.12 score on a scale
Standard Error 0.14
|
|
Weight and Eating Quality of Life (WE-QoL)
Baseline
|
1.58 score on a scale
Standard Error 0.12
|
1.50 score on a scale
Standard Error 0.14
|
|
Weight and Eating Quality of Life (WE-QoL)
9 Months
|
1.33 score on a scale
Standard Error 0.16
|
1.05 score on a scale
Standard Error 0.16
|
|
Weight and Eating Quality of Life (WE-QoL)
15 Months
|
1.18 score on a scale
Standard Error 0.17
|
1.01 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The EuroQol-5D is a 5-item self-report instrument for measurement of quality of life outcomes that has specifically been used in weight loss trials with Veterans. The EuroQoL-5D also includes the Visual Analogue Scale (VAS) which is a measure of overall self-rated health status on a 100-point scale. Units on a scale (0-100); higher=better
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in European Quality of Life (EuroQoL-5D)
Baseline
|
56.8 units on a scale
Standard Error 2.64
|
52.8 units on a scale
Standard Error 2.94
|
|
Change in European Quality of Life (EuroQoL-5D)
3 Months
|
63 units on a scale
Standard Error 2.73
|
69.05 units on a scale
Standard Error 2.57
|
|
Change in European Quality of Life (EuroQoL-5D)
9 Months
|
66.35 units on a scale
Standard Error 2.88
|
68.07 units on a scale
Standard Error 2.72
|
|
Change in European Quality of Life (EuroQoL-5D)
15 Months
|
66.27 units on a scale
Standard Error 3.29
|
63.54 units on a scale
Standard Error 3.22
|
SECONDARY outcome
Timeframe: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The NEQ is a 14-item self-report instrument for the measurement of Night Eating Syndrome (NES). A total score of greater than or equal to 25 indicates NES. Score on scale 0-52; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Night Eating Questionnaire (NEQ)
Baseline
|
21.06 score on a scale
Standard Error 1.24
|
21.25 score on a scale
Standard Error 1.37
|
|
Night Eating Questionnaire (NEQ)
3 Months
|
18.89 score on a scale
Standard Error 1.29
|
15.70 score on a scale
Standard Error 1.27
|
|
Night Eating Questionnaire (NEQ)
9 Months
|
17.89 score on a scale
Standard Error 1.18
|
16.98 score on a scale
Standard Error 1.27
|
|
Night Eating Questionnaire (NEQ)
15 Months
|
18.06 score on a scale
Standard Error 1.20
|
16.90 score on a scale
Standard Error 1.07
|
SECONDARY outcome
Timeframe: 3 month post-treatmentCBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.
Outcome measures
| Measure |
MOVE!
n=50 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
CBT Session Attendance (Treatment Dose)
|
7.75 number of sessions
Interval 0.0 to 9.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
BMI will be calculated based upon self-reported height and weight. A BMI of 25.0-29.9 indicates overweight, and 30.0 above indicates obesity. Kg/m 2; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
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Change in BMI
9 Months
|
36.55 kg/m^2
Standard Error 1.25
|
34.23 kg/m^2
Standard Error 0.89
|
|
Change in BMI
Baseline
|
38.17 kg/m^2
Standard Error 1.20
|
35.58 kg/m^2
Standard Error 0.94
|
|
Change in BMI
3 Months
|
37.24 kg/m^2
Standard Error 1.24
|
34.52 kg/m^2
Standard Error 0.96
|
|
Change in BMI
6 Months
|
36.58 kg/m^2
Standard Error 1.28
|
34.21 kg/m^2
Standard Error 0.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The WCSS is a self-report instrument that assesses the use of specific weight loss behaviors. The measure has been shown to be valid, reliable and predictive of weight loss. Score on a scale 0-4; higher=better
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in Weight Control Strategies Scale (WCSS)
Baseline
|
1.49 score on a scale
Standard Error 0.08
|
1.62 score on a scale
Standard Error 0.09
|
|
Change in Weight Control Strategies Scale (WCSS)
3 Months
|
1.81 score on a scale
Standard Error 0.1
|
2.18 score on a scale
Standard Error 0.1
|
|
Change in Weight Control Strategies Scale (WCSS)
9 Months
|
1.77 score on a scale
Standard Error 0.1
|
1.83 score on a scale
Standard Error 0.1
|
|
Change in Weight Control Strategies Scale (WCSS)
15 Months
|
1.8 score on a scale
Standard Error 0.1
|
1.71 score on a scale
Standard Error 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
The Godin is a 4-item, reliable self-report measure of physical activity that assesses the frequencies of strenuous, moderate and mild exercise and has been validated against accelerometers. Units on a scale 0-119; higher=better
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in Godin Leisure Time Exercise Questionnaire (Godin)
Baseline
|
21.36 score on a scale
Standard Error 3.45
|
26.93 score on a scale
Standard Error 3.82
|
|
Change in Godin Leisure Time Exercise Questionnaire (Godin)
3 Months
|
27.91 score on a scale
Standard Error 4.43
|
32.49 score on a scale
Standard Error 3.51
|
|
Change in Godin Leisure Time Exercise Questionnaire (Godin)
9 Months
|
30 score on a scale
Standard Error 3.68
|
25.19 score on a scale
Standard Error 4.20
|
|
Change in Godin Leisure Time Exercise Questionnaire (Godin)
15 Months
|
28.46 score on a scale
Standard Error 3.75
|
25.95 score on a scale
Standard Error 3.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post treatmentTreatment satisfaction will be measured with a number of questions to measure participants' experience as a participant on a range from strongly disagree to strongly agree (e.g., "I increased my ability to manage my binge eating" and "How likely are you to recommend this treatment to other Veterans?"). Score on a scale 0-48; higher=better
Outcome measures
| Measure |
MOVE!
n=47 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=50 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Treatment Satisfaction
|
34.43 score on a scale
Standard Error 1.39
|
40.94 score on a scale
Standard Error 0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
All weights were taken by self-report at each timepoint.
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Change in Weight
Baseline
|
253.83 lbs
Standard Error 9.32
|
235.11 lbs
Standard Error 7.41
|
|
Change in Weight
3 Months
|
247.67 lbs
Standard Error 9.43
|
227.87 lbs
Standard Error 7.12
|
|
Change in Weight
9 Months
|
243.59 lbs
Standard Error 9.96
|
225.94 lbs
Standard Error 7.06
|
|
Change in Weight
15 Months
|
243.24 lbs
Standard Error 9.67
|
226.33 lbs
Standard Error 7.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
A self-administered scale used to assess features of loss of control over eating. Score on a scale 0-4; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Loss of Control Overeating Scale (LOCES)
Baseline
|
2.64 score on a scale
Standard Error 0.18
|
2.21 score on a scale
Standard Error 0.18
|
|
Loss of Control Overeating Scale (LOCES)
3 Months
|
1.70 score on a scale
Standard Error 0.20
|
1.14 score on a scale
Standard Error 0.17
|
|
Loss of Control Overeating Scale (LOCES)
9 Months
|
1.62 score on a scale
Standard Error 0.17
|
1.11 score on a scale
Standard Error 0.17
|
|
Loss of Control Overeating Scale (LOCES)
15 Months
|
1.58 score on a scale
Standard Error 0.21
|
1.17 score on a scale
Standard Error 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentPopulation: Number analyzed is reflective of the number of participants that completed the assessment at each timepoint. Numbers differ from each timepoint due to those that were lost to follow-up.
A self-administered scale used to assess the features of food addiction. Units on a scale 0-11; higher=worse
Outcome measures
| Measure |
MOVE!
n=56 Participants
Weight management delivered as Treatment-as-Usual
MOVE!: Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. \*TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
|
MOVE!+CBT
n=53 Participants
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
MOVE!+CBT: Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
|
|---|---|---|
|
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Baseline
|
4.73 units on a scale
Standard Error 0.46
|
4.28 units on a scale
Standard Error 0.52
|
|
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
3 Months
|
3.02 units on a scale
Standard Error 0.37
|
2.35 units on a scale
Standard Error 0.35
|
|
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
9 Months
|
2.75 units on a scale
Standard Error 0.47
|
2.96 units on a scale
Standard Error 0.46
|
|
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
15 Months
|
2.53 units on a scale
Standard Error 0.45
|
2.49 units on a scale
Standard Error 0.44
|
Adverse Events
MOVE!
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
MOVE!+CBT
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