Web-Based Weight Management for Individuals With Mental Illness (eWellness)
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|ClinicalTrials.gov Identifier: NCT01324973|
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : July 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mental Disorders Schizophrenia Affective Disorders, Psychotic Overweight Obesity||Behavioral: eWellness||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Web-Based Weight Management for Individuals With Mental Illness|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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
- dietary habits [ Time Frame: 6 months ]
- physical activity [ Time Frame: 6 months ]
- weight [ Time Frame: 6 months ]
- waist circumference [ Time Frame: 6 months ]
- diet and activity-related self-efficacy, motivation, and readiness to change [ Time Frame: 6 months ]
- health-related functioning [ Time Frame: 6 months ]
- quality of life [ Time Frame: 6 months ]
- strengths, weaknesses, and barriers to the use of eWellness [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|