NCT01324973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

March 28, 2011

Last Update Submit

June 30, 2014

Conditions

Mental DisordersSchizophreniaAffective Disorders, PsychoticOverweightObesity

Keywords

Medical InformaticsTherapy, Computer-AssistedHealth EducationDietExercise

Outcome Measures

Primary Outcomes (5)

  • dietary habits

    6 months

  • physical activity

    6 months

  • weight

    6 months

  • waist circumference

    6 months

  • diet and activity-related self-efficacy, motivation, and readiness to change

    6 months

Secondary Outcomes (3)

  • health-related functioning

    6 months

  • quality of life

    6 months

  • strengths, weaknesses, and barriers to the use of eWellness

    6 months

Study Arms (2)

eWellness program

EXPERIMENTAL

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

Control group

NO INTERVENTION

Care as usual

Interventions

eWellnessBEHAVIORAL

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

Also known as: web-based weight management with peer coaching
eWellness program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Health Services and Society

Los Angeles, California, 90024, United States

Location

Related Publications (8)

  • 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.

    PMID: 15491237BACKGROUND

  • 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.

    PMID: 17453332BACKGROUND

  • 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.

    PMID: 18026812BACKGROUND

  • 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.

    PMID: 20591993BACKGROUND

  • 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.

    PMID: 23407006BACKGROUND

  • 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.

    PMID: 24091610BACKGROUND

  • 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.

    PMID: 22430566BACKGROUND

  • 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.

    PMID: 24382767RESULT

MeSH Terms

Conditions

Mental DisordersSchizophreniaAffective Disorders, PsychoticOverweightObesityHealth EducationMotor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Alexander S Young, MD, MSHS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 2, 2014

Record last verified: 2014-06

Locations

US(1)