Web-Based Weight Management for Individuals With Mental Illness (eWellness)
Primary Purpose
Mental Disorders, Schizophrenia, Affective Disorders, Psychotic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eWellness
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring Medical Informatics, Therapy, Computer-Assisted, Health Education, Diet, Exercise
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
Sites / Locations
- UCLA Center for Health Services and Society
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
eWellness program
Control group
Arm Description
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.
Care as usual
Outcomes
Primary Outcome Measures
dietary habits
physical activity
weight
waist circumference
diet and activity-related self-efficacy, motivation, and readiness to change
Secondary Outcome Measures
health-related functioning
quality of life
strengths, weaknesses, and barriers to the use of eWellness
Full Information
NCT ID
NCT01324973
First Posted
March 28, 2011
Last Updated
June 30, 2014
Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Mental Health, University of Maryland
1. Study Identification
Unique Protocol Identification Number
NCT01324973
Brief Title
Web-Based Weight Management for Individuals With Mental Illness
Acronym
eWellness
Official Title
Web-Based Weight Management for Individuals With Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Mental Health, University of Maryland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Schizophrenia, Affective Disorders, Psychotic, Overweight, Obesity
Keywords
Medical Informatics, Therapy, Computer-Assisted, Health Education, Diet, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eWellness program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
eWellness
Other Intervention Name(s)
web-based weight management with peer coaching
Intervention Description
A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.
Primary Outcome Measure Information:
Title
dietary habits
Time Frame
6 months
Title
physical activity
Time Frame
6 months
Title
weight
Time Frame
6 months
Title
waist circumference
Time Frame
6 months
Title
diet and activity-related self-efficacy, motivation, and readiness to change
Time Frame
6 months
Secondary Outcome Measure Information:
Title
health-related functioning
Time Frame
6 months
Title
quality of life
Time Frame
6 months
Title
strengths, weaknesses, and barriers to the use of eWellness
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Young, MD, MSHS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Health Services and Society
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15491237
Citation
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.
Results Reference
background
PubMed Identifier
17453332
Citation
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.
Results Reference
background
PubMed Identifier
18026812
Citation
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.
Results Reference
background
PubMed Identifier
20591993
Citation
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.
Results Reference
background
PubMed Identifier
23407006
Citation
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.
Results Reference
background
PubMed Identifier
24091610
Citation
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.
Results Reference
background
PubMed Identifier
22430566
Citation
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.
Results Reference
background
PubMed Identifier
24382767
Citation
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.
Results Reference
result
Learn more about this trial
Web-Based Weight Management for Individuals With Mental Illness
We'll reach out to this number within 24 hrs