Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)

Obesity Clinical Trial

— Web-MOVE!  

Official title:

Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983476
• Other study ID #: IIR 09-083
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: September 15, 2015
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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 complete and the interventions have been evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Behaviors
• Mental Disorders
• Obesity
• Psychotic Disorders

Intervention

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))
• 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))

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cohen AN, Golden JF, Young AS. Peer wellness coaches for adults with mental illness. Psychiatr Serv. 2014 Jan 1;65(1):129-30. doi: 10.1176/appi.ps.650101. — View Citation

Hamilton AB, Chinman M, Cohen AN, Oberman RS, Young AS. Implementation of consumer providers into mental health intensive case management teams. J Behav Health Serv Res. 2015 Jan;42(1):100-8. doi: 10.1007/s11414-013-9365-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI, self-efficacy, motivation, readiness to change, dietary habits, physical activity,		6 months	No
Secondary	health related functioning, quality of life, psychopathology, satisfaction and usability of intervention		6 months	No
Secondary	qualitative assessment of satisfaction, usability, strengths, weaknesses, barriers of intervention		6 months	No
Secondary	BMI		9 months	No
Secondary	BMI		12 months	No

External Links

•   VA MOVE! Program