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Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI) (Web-MOVE!)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00983476
First received: September 22, 2009
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
Obesity and physical inactivity have reached epidemic proportions, resulting in increased rates of a variety of chronic diseases, increased risk of death, and substantial health care costs. Individuals with serious mental illness are even more likely to be overweight or obese, which contributes to the high rate of co-morbid medical disease and early mortality found among this population. Specific individual and group-based psychoeducational interventions have repeatedly and consistently been shown to help adults with serious mental illness improve their weight. However, these require substantial time from mental health clinicians, and frequent visits by patients to mental health clinics. This creates challenges for patients who may need to travel to a medical center that provides these services, and who often have limited transportation options. It is likely that these barriers can be addressed with a computerized, web-based intervention focused on diet and exercise education, and tailored for veterans with serious mental illness. Web-based systems can deliver content that is intensive, engaging, and tailored to the needs and preferences of specific patients. Web-based systems can be delivered using computers at community-based outpatient Clinics or other settings in the community. The objective of this project is to develop and evaluate the effectiveness of a web-based intervention to help patients with serious mental illness lose weight.

Condition Intervention
Psychotic Disorders Obesity Health Behaviors Behavioral: in-person MOVE! SMI Behavioral: web-based MOVE! SMI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: 6 months ]
    BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1

  • Body Mass Index (BMI) Within Obese Sample [ Time Frame: 6 months ]
    BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30

  • Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change) [ Time Frame: 6 months ]

    Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor.

    The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max).


  • Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change) [ Time Frame: 6 months ]

    Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor.

    The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max).



Secondary Outcome Measures:
  • Quality of Life: Physical Functioning [ Time Frame: 6 months ]

    Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale.

    The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max).


  • Quality of Life: Self-Esteem [ Time Frame: 6 months ]

    Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale.

    The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max).


  • Quality of Life: Sexual Life [ Time Frame: 6 months ]

    Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale.

    The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max).


  • BMI [ Time Frame: 9 months ]
    BMI = (weight in pounds * 703)/ height in inches²

  • BMI [ Time Frame: 12 months ]
    BMI = (weight in pounds * 703)/ height in inches²


Enrollment: 276
Study Start Date: March 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
in-person MOVE! SMI
Behavioral: in-person MOVE! SMI
Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
Experimental: Arm 2
web-based MOVE! SMI
Behavioral: web-based MOVE! SMI
online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
No Intervention: Arm 3
usual care + educational handouts regarding weight loss

Detailed Description:

Background: Obesity has reached epidemic proportions, and often has serious adverse health consequences. The VA has deployed a "MOVE! Weight Management Program" nationally in the general patient population. Since individuals with serious mental illness (SMI) often have cognitive deficits, specialized psychoeducational interventions are needed in this population. Specialized psychoeducational interventions for weight have been developed and studied in populations with SMI. This evidence-based practice has been adapted for use in VA, resulting in a "MOVE! SMI" intervention. However, it has proven to be quite difficult to disseminate this intervention. Patients with SMI often have limited transportation options, and may not want to participate in groups. Also, in-person MOVE! SMI requires substantial time from mental health clinicians. This clinician time has been difficult to deploy or is not available at many clinic locations. It is likely that these barriers can be addressed with a computerized, web-based version of MOVE! . Specialized web-based approaches have been studied and found to be successful in people with SMI, and can deliver content that is intensive and engaging with minimal requirements for staff time.

Objectives: The VA Network 5 and 22 Mental Illness Research, Education, and Clinical Centers (MIRECCs) developed a web-based system that provides computerized counseling regarding diet to individuals with SMI. The proposed project expanded this system. This project's objectives are to: 1) develop a comprehensive web-based system that delivers MOVE! using design features that meet the needs of individuals with mental illness; 2) evaluate the effectiveness, in patients with serious mental illness, of web-based MOVE! compared with in-person MOVE! and a control group; and, 3) characterize, from the patient's perspective, the strengths, weaknesses, and barriers to the use of in-person and web-based MOVE!.

Methods: This is a prospective, randomized, controlled trial in patients with SMI who are obese and receiving treatment with medications that often have weight gain as a major side-effect. Participants are assigned to in-person MOVE! SMI, web-based MOVE! SMI with support from peer coaches, or a comparison group. Research assessments occur at 0, 3, 6, 9 and 12 months. Changes in outcomes are compared over time between the three groups. Comparative effectiveness is evaluated at 6 months. A secondary objective is to evaluate the extent to which gains are maintained at 9 and 12 months.

Status: The project team developed the needed materials, methods, and informatics systems. Patients were enrolled, and study enrollment and interventions are complete. Follow up interviews are complete and the interventions have been evaluated.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or PTSD;
  • age 18 and over;
  • no psychiatric hospitalization during the month prior to enrollment;
  • receipt of an antipsychotic medication for at least 3 months prior to enrollment;
  • BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain;
  • medical clearance to participate from a VA physician;
  • control over diet.

Exclusion Criteria:

  • any medical condition for which a weight program is contraindicated;
  • history of bariatric surgery;
  • pregnant and nursing mothers;
  • a 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: NCT00983476

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Alexander S Young, MD MSHS VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  More Information

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00983476     History of Changes
Other Study ID Numbers: IIR 09-083
Study First Received: September 22, 2009
Results First Received: December 20, 2016
Last Updated: March 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Randomized controlled trial
Obesity
Comparative Effectiveness
Clinical practice guidelines
Medical Informatics Computing
Services, Mental Health
Self-care
Psychotic disorders
Mental Health Care
Veterans

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on September 21, 2017