Clinical trial NCT00983476: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)
Official title: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Obesity
Health Behaviors
Keywords: Randomized controlled trial
Obesity
Comparative Effectiveness
Clinical practice guidelines
Medical Informatics Computing
Services, Mental Health
Self-care
Psychotic disorders
Mental Health Care
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-09-24
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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) developed a web-based system that provides computerized counseling regarding diet to individuals with SMI. The proposed project expanded 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 were enrolled, and study enrollment and interventions are complete. Follow up interviews are complete and the interventions have been evaluated.

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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 6 months
measure: Body Mass Index (BMI) Within Obese Sample
timeFrame: 6 months
measure: Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)
timeFrame: 6 months
measure: Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life: Physical Functioning
timeFrame: 6 months
measure: Quality of Life: Self-Esteem
timeFrame: 6 months
measure: Quality of Life: Sexual Life
timeFrame: 6 months
measure: BMI
timeFrame: 9 months
measure: BMI
timeFrame: 12 months
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alexander S Young, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
citation: Muralidharan A, Brown CH, Zhang Y, Niv N, Cohen AN, Kreyenbuhl J, Oberman RS, Goldberg RW, Young AS. Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness. J Behav Med. 2020 Oct;43(5):865-872. doi: 10.1007/s10865-019-00117-1. Epub 2019 Nov 18.