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Web-Based Weight Management for Individuals With Mental Illness (eWellness)

This study is not yet open for participant recruitment.
Verified March 2011 by University of California, Los Angeles
Sponsor:
Collaborators:
University of Maryland
Los Angeles County Department of Mental Health
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01324973
First received: March 28, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Mental Disorders
Schizophrenia
Affective Disorders, Psychotic
Overweight
Obesity
 Behavioral: eWellness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Web-Based Weight Management for Individuals With Mental Illness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eWellness program
A comprehensive web-based program that delivers evidence-based weight management that meets the needs of individuals with mental illness.
 Behavioral: eWellness
A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity.
Other Name: web-based weight management
No Intervention: Control group
Care as usual

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 90 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 a comparison group. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis
  • age 18 and over
  • prescribed antipsychotic medication for at least 3 months
  • BMI of 30 or higher or recent weight gain
  • medical clearance to participate

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 or Mini-Mental Status Examination score of 23 or less
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324973

Contacts
Contact: Dawn Glover, MA 310-478-3711 ext 48338 dawnglover@ucla.edu

Locations
United States, California
UCLA Center for Health Services and Society Not yet recruiting
Los Angeles, California, United States, 90024
Sub-Investigator: Noosha Niv, PhD            
Sub-Investigator: Amy N Cohen, PhD            
Sponsors and Collaborators
University of California, Los Angeles
University of Maryland
Los Angeles County Department of Mental Health
Investigators
Principal Investigator: Alexander S Young, MD, MSHS University of California, Los Angeles
  More Information

Publications:

Responsible Party: Alexander S. Young, MD MSHS / Professor, UCLA
ClinicalTrials.gov Identifier: NCT01324973     History of Changes
Other Study ID Numbers: 5R34MH090207
Study First Received: March 28, 2011
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Medical Informatics
Therapy, Computer-Assisted
Health Education
Diet
Exercise

Additional relevant MeSH terms:
Mental Disorders
Affective Disorders, Psychotic
Psychotic Disorders
Obesity
Schizophrenia
Overweight
 Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013