Web-Based Weight Management for Individuals With Mental Illness

Study Overview
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Brief Summary
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Obesity and physical inactivity have become serious problems for individuals with mental illness, resulting in increased rates of chronic disease, premature death, and substantial health care costs. Although in-person psychoeducational interventions help individuals with mental illness manage their weight, these interventions are often not used because they require frequent travel to treatment programs and substantial time from clinicians. This project addresses these barriers by developing and evaluating the effectiveness of an web-based computer system that is focused on diet and exercise education, and designed to help individuals with mental illness manage their weight.

Detailed Description
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Background/Rationale: Obesity and physical inactivity have reached epidemic proportions, resulting in increased rates of chronic disease, premature death, and substantial health care costs. Excess weight is even more prevalent in populations with serious mental illnesses (SMI), in part due to medication-induced weight gain and social disadvantage. Since individuals with SMI often have cognitive deficits, specialized approaches are required to help people manage their weight. Researchers have found that specialized in-person interventions focused on diet and activity can help individuals with SMI manage their weight. However, these evidence-based practices have not been widely disseminated. Barriers to the use of these interventions include reluctance of individuals to participate in groups, difficulty finding transportation for frequent visits to clinics, a shortage of trained clinicians, and inadequate clinician time to provide the interventions. It is likely that these barriers can be addressed with a web-based weight intervention that is tailored for individuals with SMI. Specialized web-based approaches have been studied and found to be effective in this population, and can deliver content that is intensive and engaging with minimal requirements for clinician time. Objectives: The investigators on this proposal previously developed a prototype web-based system that provides limited diet education to individuals with SMI. The current project extends and evaluates this system. The project's objectives are to: 1) build on the prototype to develop eWellness, a comprehensive web-based system that delivers an evidence-based weight management program focused on diet and activity, and that meets the needs of individuals with SMI; 2) evaluate the effectiveness, in individuals with SMI, of an eWellness program compared with a control group; and, 3) characterize, from the perspective of individuals with SMI, the strengths, weaknesses, and barriers to the use of eWellness. Methods: This is a randomized, controlled trial of individuals with SMI at a community mental health center who are overweight and prescribed medications that have weight gain as a common side-effect. Participants are assigned to the eWellness program or to continue with usual care. Research assessments occur at baseline, 3, and 6 months. Changes in outcomes are compared over time between the two groups. Significance: By losing weight, individuals with mental illness can decrease their risk for medical problems, and improve their quality of life and life expectancy. A web-based system that helps individuals lose weight could be feasible to disseminate broadly at medical centers, clinics, and community based programs in both rural and urban areas.

Official Title
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Web-Based Weight Management for Individuals With Mental Illness

Conditions
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Mental Disorders, Schizophrenia, Affective Disorders, Psychotic, Overweight, Obesity

Intervention / Treatment
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* Behavioral: eWellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or chronic PTSD age 18 and over prescribed antipsychotic medication for at least 3 months BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain medical clearance to participate control over diet Exclusion Criteria: any medical condition for which a weight program is contraindicated history of bariatric surgery psychiatric hospitalization during the prior month pregnant and nursing mothers 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: eWellness program<br>A comprehensive program that delivers web-based, evidence-based weight management; and structured peer supports. The program is designed to meet the needs of individuals with mental illness. | Behavioral: eWellness<br>* A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.<br>* Other names: web-based weight management with peer coaching;|
| No Intervention: Control group<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary habits |  | 6 months | 
| physical activity |  | 6 months | 
| weight |  | 6 months | 
| waist circumference |  | 6 months | 
| diet and activity-related self-efficacy, motivation, and readiness to change |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related functioning |  | 6 months | 
| quality of life |  | 6 months | 
| strengths, weaknesses, and barriers to the use of eWellness |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Informatics, Therapy, Computer-Assisted, Health Education, Diet, Exercise