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This study involves a controlled trial of an optimized version of a weight management and physical activity psycho-educational intervention (called MOVE!) with 200 obese and overweight veterans with serious mental illness.
This study involves a controlled trial of an optimized version of a weight management and physical activity psycho-educational intervention (called MOVE!) for overweight and obese Veterans with serious mental illness. The study hypothesizes that MOVE! will result in weight loss and improved indicators of cardiovascular risk when compared to usual care. Medical outcomes are proportion achieving 4% or higher weight loss, mean weight loss, and reductions in cardiovascular risk (blood pressure, glucose and serum lipids). Psychosocial outcomes are general health, psychiatric functioning, quality of life, and self-esteem and medication adherence. Mediators include physical activity, dietary management, self-efficacy, and motivation/readiness to change. The intervention involves a well specified combination of individualized and group based services and draws on evidence based techniques and materials that are currently well packaged in an existing VA program called MOVE! The Comparison condition is operationalized as usual treatment plus monthly weight measurements and distribution of educational brochures regarding diet and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. |
|
| Arm 2 | No Intervention | The control group offers basic information about diet and exercise every month for six months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOVE! | Behavioral | group based psychoeducation, motivation and support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Measurement | Weight taken at the baseline assessment and again at the 6 month assessment | baseline and six months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Weight on Quality of Life Survey (IWQOL) | Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life. | baseline and six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Goldberg, PhD | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23584716 | Result | Goldberg RW, Reeves G, Tapscott S, Medoff D, Dickerson F, Goldberg AP, Ryan AS, Fang LJ, Dixon LB. "MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. Psychiatr Serv. 2013 Aug 1;64(8):737-44. doi: 10.1176/appi.ps.201200314. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MOVE Group | The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support |
| FG001 | Control Group | The control group offers basic information about diet and exercise every month for six months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MOVE Group | The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Measurement | Weight taken at the baseline assessment and again at the 6 month assessment | Mean | Standard Deviation | pounds | baseline and six months |
|
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Adverse Events were reviewed for this study, although none were observed during the research trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOVE Group | The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard W. Goldberg, Ph.D. | VA VISN 5 Mental Illness Research, Education and Clinical Center | 410-637-1851 | richard.goldberg@va.gov |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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The control condition offers basic information about diet and exercise on a monthly basis. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Impact of Weight on Quality of Life Survey (IWQOL) | Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life. | Mean | Standard Deviation | units on a scale | baseline and six months |
|
|
|
|
| 0 |
| 56 |
| 0 |
| 53 |
| EG001 | Control Group | The control condition offers basic information about diet and exercise on a monthly basis. | 0 | 56 | 0 | 56 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |