Web-Based Weight Management for Individuals With Mental Illness

NCT ID: NCT01324973

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

eWellness

Intervention Type: BEHAVIORAL

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

Control group

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eWellness

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

Intervention Type: BEHAVIORAL

Other Intervention Names

web-based weight management with peer coaching

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Los Angeles County Department of Mental Health

UNKNOWN

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Alexander S. Young, MD MSHS

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander S Young, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Health Services and Society

Los Angeles, California, United States

Countries

United States

References

Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.

Reference Type: BACKGROUND

PMID: 15491237 (View on PubMed)

Chinman M, Hassell J, Magnabosco J, Nowlin-Finch N, Marusak S, Young AS. The feasibility of computerized patient self-assessment at mental health clinics. Adm Policy Ment Health. 2007 Jul;34(4):401-9. doi: 10.1007/s10488-007-0120-4. Epub 2007 Apr 24.

Reference Type: BACKGROUND

PMID: 17453332 (View on PubMed)

Young AS, Chaney E, Shoai R, Bonner L, Cohen AN, Doebbeling B, Dorr D, Goldstein MK, Kerr E, Nichol P, Perrin R. Information technology to support improved care for chronic illness. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):425-30. doi: 10.1007/s11606-007-0303-4.

Reference Type: BACKGROUND

PMID: 18026812 (View on PubMed)

Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.

Reference Type: BACKGROUND

PMID: 20591993 (View on PubMed)

Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.

Reference Type: BACKGROUND

PMID: 23407006 (View on PubMed)

Hamilton AB, Chinman M, Cohen AN, Oberman RS, Young AS. Implementation of consumer providers into mental health intensive case management teams. J Behav Health Serv Res. 2015 Jan;42(1):100-8. doi: 10.1007/s11414-013-9365-8.

Reference Type: BACKGROUND

PMID: 24091610 (View on PubMed)

Niv N, Cohen AN, Hamilton A, Reist C, Young AS. Effectiveness of a psychosocial weight management program for individuals with schizophrenia. J Behav Health Serv Res. 2014 Jul;41(3):370-80. doi: 10.1007/s11414-012-9273-3.

Reference Type: BACKGROUND

PMID: 22430566 (View on PubMed)

Cohen AN, Golden JF, Young AS. Peer wellness coaches for adults with mental illness. Psychiatr Serv. 2014 Jan 1;65(1):129-30. doi: 10.1176/appi.ps.650101. No abstract available.

Reference Type: RESULT

PMID: 24382767 (View on PubMed)

Other Identifiers

5R34MH090207

Identifier Type: NIH

Identifier Source: org_study_id

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