Mental Illness, Obesity
Conditions
Keywords
Behavioral interventions, Mental Illness, Obesity, Psycho-educational interventions, Weight management
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMOVE!
group based psychoeducation, motivation and support
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* DSM- IV diagnosis of schizophrenia spectrum disorders OR a DSM-IV diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder; * Age between 18-64; * No psychiatric hospitalization in 3-month period prior to enrollment; * Community residency within 30 miles of either VA facility; * A BMI of 25 or higher; * Voluntary consent after receiving full information about the study; * English speaking; * Veteran of the armed forces
Exclusion criteria
* Active cancer other than non-melanoma skin cancer * end stage chronic obstructive pulmonary disease * end stage congestive heart failure * end-stage neurological disorder * problematic substance abuse as defined by provider * end stage renal disease * moderate to severe cognitive impairment (dementia, post-stroke) * HIV positive with a CD4 count less than or equal to 350 within the last 6 months * anorexia * current pregnancy, currently nursing or planning to become pregnant in the next 6 months * those living in long-term care facilities * use in past 3 months of prescription pharmacological agents for weight loss * no chart documented VA delivered medical primary care or general somatic care visit within the last 18 months * most recent chart documented hematocrit level obtained within last six months is at or below 30% * most recent chart documented creatinine level obtained within the last six months that is at or above 2.5 * most recent chart documented liver function tests obtained within the last six months exceeds twice the normal value for ALT, AST test in the Baltimore VA laboratory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Measurement | baseline and six months | Weight taken at the baseline assessment and again at the 6 month assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Weight on Quality of Life Survey (IWQOL) | baseline and six months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| Control Group The control condition offers basic information about diet and exercise on a monthly basis. | 56 |
| Total | 109 |
Baseline characteristics
| Characteristic | MOVE Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 54 Participants | 107 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 29 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 21 Participants | 37 Participants |
| Region of Enrollment United States | 53 participants | 56 participants | 109 participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 21 Participants |
| Sex: Female, Male Male | 40 Participants | 48 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
Weight Measurement
Weight taken at the baseline assessment and again at the 6 month assessment
Time frame: baseline and six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOVE Group | Weight Measurement | Baseline Weight | 237.2 pounds | Standard Deviation 50.3 |
| MOVE Group | Weight Measurement | 6 Month follow up | 240.8 pounds | Standard Deviation 40.1 |
| Control Group | Weight Measurement | 6 Month follow up | 228.1 pounds | Standard Deviation 43.4 |
| Control Group | Weight Measurement | Baseline Weight | 230.2 pounds | Standard Deviation 45.7 |
p-value: 0.72ANOVA
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.
Time frame: baseline and six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOVE Group | Impact of Weight on Quality of Life Survey (IWQOL) | Baseline | 67.6 units on a scale | Standard Deviation 18.4 |
| MOVE Group | Impact of Weight on Quality of Life Survey (IWQOL) | 6 Month Follow up | 75.1 units on a scale | Standard Deviation 15.7 |
| Control Group | Impact of Weight on Quality of Life Survey (IWQOL) | Baseline | 73.5 units on a scale | Standard Deviation 21.4 |
| Control Group | Impact of Weight on Quality of Life Survey (IWQOL) | 6 Month Follow up | 78.9 units on a scale | Standard Deviation 19.1 |
p-value: 0.71ANOVA