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

This study has been completed.
Sponsor:
Collaborators:
Los Angeles County Department of Mental Health
University of Maryland
Information provided by (Responsible Party):
Alexander S. Young, MD MSHS, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01324973
First received: March 28, 2011
Last updated: June 30, 2014
Last verified: June 2014
  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: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-Based Weight Management for Individuals With Mental Illness

Resource links provided by NLM:


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 ]
  • diet and activity-related self-efficacy, motivation, and readiness to change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: eWellness
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

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.

  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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324973

Locations
United States, California
UCLA Center for Health Services and Society
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles County Department of Mental Health
University of Maryland
Investigators
Principal Investigator: Alexander S Young, MD, MSHS University of California, Los Angeles
  More Information

Publications:

Responsible Party: Alexander S. Young, MD MSHS, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01324973     History of Changes
Other Study ID Numbers: 5R34MH090207
Study First Received: March 28, 2011
Last Updated: June 30, 2014
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:
Affective Disorders, Psychotic
Disease
Mental Disorders
Mood Disorders
Overweight
Psychotic Disorders
Schizophrenia
Body Weight
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014