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Web-Based Weight Management for Individuals With Mental Illness

Web-Based Weight Management for Individuals With Mental Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01324973
Acronym
eWellness
Enrollment
60
Registered
2011-03-29
Start date
2012-03-31
Completion date
2014-04-30
Last updated
2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Medical Informatics, Therapy, Computer-Assisted, Health Education, Diet, Exercise

Brief summary

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

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.

Interventions

BEHAVIORALeWellness

A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.

Sponsors

Los Angeles County Department of Mental Health
CollaboratorUNKNOWN
University of Maryland
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
diet and activity-related self-efficacy, motivation, and readiness to change6 months
physical activity6 months
weight6 months
waist circumference6 months
dietary habits6 months

Secondary

MeasureTime frame
quality of life6 months
strengths, weaknesses, and barriers to the use of eWellness6 months
health-related functioning6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026