Web-Based Weight Management for Individuals With Mental Illness (eWellness)
Affective Disorders, Psychotic
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Web-Based Weight Management for Individuals With Mental Illness|
- dietary habits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- diet and activity-related self-efficacy, motivation, and readiness to change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- health-related functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- strengths, weaknesses, and barriers to the use of eWellness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: eWellness program
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.
A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.
Other Name: web-based weight management with peer coaching
No Intervention: Control group
Care as usual
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324973
|United States, California|
|UCLA Center for Health Services and Society|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Alexander S Young, MD, MSHS||University of California, Los Angeles|