N/A
Completed N=276
Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)
Psychotic disorders · Obesity · Health Behaviors
Source: ClinicalTrials.gov NCT00983476 ↗
Enrolled (actual)
276
Serious AEs
1.8%
Results posted
Feb 2017
Primary outcomePrimary: Body Mass Index (BMI) — 34.9; 33.4; 34.4 kg/(meters squared) — p=0.11
Summary
Obesity and physical inactivity have reached epidemic proportions, resulting in increased rates of a variety of chronic diseases, increased risk of death, and substantial health care costs. Individuals with serious mental illness are even more likely to be overweight or obese, which contributes to the high rate of co-morbid medical disease and early mortality found among this population. Specific individual and group-based psychoeducational interventions have repeatedly and consistently been shown to help adults with serious mental illness improve their weight. However, these require substantial time from mental health clinicians, and frequent visits by patients to mental health clinics. This creates challenges for patients who may need to travel to a medical center that provides these services, and who often have limited transportation options. It is likely that these barriers can be addressed with a computerized, web-based intervention focused on diet and exercise education, and tailored for veterans with serious mental illness. Web-based systems can deliver content that is intensive, engaging, and tailored to the needs and preferences of specific patients. Web-based systems can be delivered using computers at community-based outpatient Clinics or other settings in the community. The objective of this project is to develop and evaluate the effectiveness of a web-based intervention to help patients with serious mental illness lose weight.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (BMI) |
34.9; 33.4; 34.4 | 0.11 |
| PRIMARY Body Mass Index (BMI) Within Obese Sample |
35.9; 34.2; 35.6 | 0.02 sig |
| PRIMARY Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) |
4.1; 3.9; 4.0 | 0.32 |
| PRIMARY Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) |
4.1; 3.9; 3.8 | 0.11 |
| SECONDARY Quality of Life: Physical Functioning |
2.4; 2.4; 2.6 | 0.47 |
| SECONDARY Quality of Life: Self-Esteem |
2.3; 2.3; 2.5 | 0.51 |
| SECONDARY Quality of Life: Sexual Life |
1.7; 1.8; 1.7 | 0.83 |
| SECONDARY BMI |
34.7; 32.4; 34.0 | — |
| SECONDARY BMI |
34.7; 32.4; 34.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or PTSD;
- age 18 and over;
- no psychiatric hospitalization during the month prior to enrollment;
- receipt of an antipsychotic medication for at least 3 months prior to enrollment;
- BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain;
- medical clearance to participate from a VA physician;
- control over diet.
Exclusion Criteria
- any medical condition for which a weight program is contraindicated;
- history of bariatric surgery;
- pregnant and nursing mothers;
- a diagnosis of dementia;
- not able to provide informed consent by self or legally appointed representative.
Data sourced from ClinicalTrials.gov (NCT00983476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.