search
Back to results

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

Primary Purpose

Psychotic Disorders, Obesity, Health Behaviors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
in-person MOVE! SMI
web-based MOVE! SMI
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Randomized controlled trial, Obesity, Comparative Effectiveness, Clinical practice guidelines, Medical Informatics Computing, Services, Mental Health, Self-care, Psychotic disorders, Mental Health Care, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

in-person MOVE! SMI

web-based MOVE! SMI

usual care + educational handouts regarding weight loss

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)
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
BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30
Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)
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)
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
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
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
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
BMI = (weight in pounds * 703)/ height in inches²
BMI
BMI = (weight in pounds * 703)/ height in inches²

Full Information

First Posted
September 22, 2009
Last Updated
March 14, 2017
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00983476
Brief Title
Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)
Acronym
Web-MOVE!
Official Title
Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Obesity, Health Behaviors
Keywords
Randomized controlled trial, Obesity, Comparative Effectiveness, Clinical practice guidelines, Medical Informatics Computing, Services, Mental Health, Self-care, Psychotic disorders, Mental Health Care, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
in-person MOVE! SMI
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
web-based MOVE! SMI
Arm Title
Arm 3
Arm Type
No Intervention
Arm Description
usual care + educational handouts regarding weight loss
Intervention Type
Behavioral
Intervention Name(s)
in-person MOVE! SMI
Intervention Description
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))
Intervention Type
Behavioral
Intervention Name(s)
web-based MOVE! SMI
Intervention Description
online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1
Time Frame
6 months
Title
Body Mass Index (BMI) Within Obese Sample
Description
BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30
Time Frame
6 months
Title
Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)
Description
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).
Time Frame
6 months
Title
Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life: Physical Functioning
Description
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).
Time Frame
6 months
Title
Quality of Life: Self-Esteem
Description
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).
Time Frame
6 months
Title
Quality of Life: Sexual Life
Description
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).
Time Frame
6 months
Title
BMI
Description
BMI = (weight in pounds * 703)/ height in inches²
Time Frame
9 months
Title
BMI
Description
BMI = (weight in pounds * 703)/ height in inches²
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Young, MD MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
PubMed Identifier
31741204
Citation
Muralidharan A, Brown CH, Zhang Y, Niv N, Cohen AN, Kreyenbuhl J, Oberman RS, Goldberg RW, Young AS. Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness. J Behav Med. 2020 Oct;43(5):865-872. doi: 10.1007/s10865-019-00117-1. Epub 2019 Nov 18.
Results Reference
derived
Links:
URL
http://www.move.va.gov/
Description
VA MOVE! Program

Learn more about this trial

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

We'll reach out to this number within 24 hrs