UCLA Center for Health Services and Society
Los Angeles, California, 90024, United States
NCT Number: NCT01324973
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90024, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.
Other names: web-based weight management with peer coaching
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
University of California, Los Angeles
Other
Acronym: eWellness
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02183844
Adherence Interventions, Behavior
Los Angeles, California, United States
View Trial DetailsNCT02077829
Affective Disorders, Psychotic, Bipolar Disorder
Lørenskog, Norway
View Trial DetailsNCT02744989
Mental Disorders, Schizophrenia
Bron, France
View Trial DetailsNCT05321602
Antipsychotic Agents, Central Nervous System Depression
Little Rock, Arkansas, United States
View Trial Details