Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI) (Web-MOVE!)
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.
Behavioral: in-person MOVE! SMI
Behavioral: web-based MOVE! SMI
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness|
- BMI, self-efficacy, motivation, readiness to change, dietary habits, physical activity, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- health related functioning, quality of life, psychopathology, satisfaction and usability of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- qualitative assessment of satisfaction, usability, strengths, weaknesses, barriers of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- BMI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
in-person MOVE! SMI
Behavioral: in-person MOVE! SMI
Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
Experimental: Arm 2
web-based MOVE! SMI
Behavioral: web-based MOVE! SMI
online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
No Intervention: Arm 3
usual care + educational handouts regarding weight loss
Background: Obesity has reached epidemic proportions, and often has serious adverse health consequences. The VA has deployed a "MOVE! Weight Management Program" nationally in the general patient population. Since individuals with serious mental illness (SMI) often have cognitive deficits, specialized psychoeducational interventions are needed in this population. Specialized psychoeducational interventions for weight have been developed and studied in populations with SMI. This evidence-based practice has been adapted for use in VA, resulting in a "MOVE! SMI" intervention. However, it has proven to be quite difficult to disseminate this intervention. Patients with SMI often have limited transportation options, and may not want to participate in groups. Also, in-person MOVE! SMI requires substantial time from mental health clinicians. This clinician time has been difficult to deploy or is not available at many clinic locations. It is likely that these barriers can be addressed with a computerized, web-based version of MOVE! . Specialized web-based approaches have been studied and found to be successful in people with SMI, and can deliver content that is intensive and engaging with minimal requirements for staff time.
Objectives: The VA Network 5 and 22 Mental Illness Research, Education, and Clinical Centers (MIRECCs) have developed a prototype web-based system that provides computerized counseling regarding diet to individuals with SMI. The proposed project expands this system. This project's objectives are to: 1) develop a comprehensive web-based system that delivers MOVE! using design features that meet the needs of individuals with mental illness; 2) evaluate the effectiveness, in patients with serious mental illness, of web-based MOVE! compared with in-person MOVE! and a control group; and, 3) characterize, from the patient's perspective, the strengths, weaknesses, and barriers to the use of in-person and web-based MOVE!.
Methods: This is a prospective, randomized, controlled trial in patients with SMI who are obese and receiving treatment with medications that often have weight gain as a major side-effect. Participants are assigned to in-person MOVE! SMI, web-based MOVE! SMI with support from peer coaches, or a comparison group. Research assessments occur at 0, 3, 6, 9 and 12 months. Changes in outcomes are compared over time between the three groups. Comparative effectiveness is evaluated at 6 months. A secondary objective is to evaluate the extent to which gains are maintained at 9 and 12 months.
Status: The project team developed the needed materials, methods, and informatics systems. Patients have been enrolled, and study enrollment and interventions are now complete. Follow up interviews are occurring and and the interventions are being evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983476
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Alexander Stehle Young, MD MSHS||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|