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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychotic Disorders, Obesity, Health Behaviors

Intervention / Treatment
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* Behavioral: in-person MOVE! SMI
* Behavioral: web-based MOVE! SMI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>in-person MOVE! SMI | Behavioral: in-person MOVE! SMI<br>* Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))<br>|
| Experimental: Arm 2<br>web-based MOVE! SMI | Behavioral: web-based MOVE! SMI<br>* online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))<br>|
| No Intervention: Arm 3<br>usual care + educational handouts regarding weight loss | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1 | 6 months | 
| Body Mass Index (BMI) Within Obese Sample | BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30 | 6 months | 
| Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) | Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor. The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max). | 6 months | 
| Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) | Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor. The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life: Physical Functioning | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale. The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | 6 months | 
| Quality of Life: Self-Esteem | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale. The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | 6 months | 
| Quality of Life: Sexual Life | Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale. The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max). | 6 months | 
| BMI | BMI = (weight in pounds * 703)/ height in inches² | 9 months | 
| BMI | BMI = (weight in pounds * 703)/ height in inches² | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Obesity, Comparative Effectiveness, Clinical practice guidelines, Medical Informatics Computing, Services, Mental Health, Self-care, Psychotic disorders, Mental Health Care, Veterans