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

NCT00983476 | Completed Results

• 1 other identifier: IIR 09-083
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

  6 months

• Body Mass Index (BMI) Within Obese Sample

  BMI = (weight in pounds \* 703)/ (height in inches²); obese defined as BMI \> 30

  6 months

• 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).

  6 months

• 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).

  6 months

Secondary Outcomes (5)

• Quality of Life: Physical Functioning

  6 months

• Quality of Life: Self-Esteem

  6 months

• Quality of Life: Sexual Life

  6 months

• BMI

  9 months

• BMI

  12 months

Study Arms (3)

Arm 1

EXPERIMENTAL

in-person MOVE! SMI

Behavioral: in-person MOVE! SMI

Arm 2

EXPERIMENTAL

web-based MOVE! SMI

Behavioral: web-based MOVE! SMI

Arm 3

NO INTERVENTION

usual care + educational handouts regarding weight loss

Interventions

in-person MOVE! SMI BEHAVIORAL

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))

Arm 1

web-based MOVE! SMI BEHAVIORAL

online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Los Angeles, California, 90073, United States

Location

Related Publications (2)

• 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: 24382767 RESULT

• 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.

  PMID: 31741204 DERIVED

Related Links

• VA MOVE! Program

MeSH Terms

Conditions

Psychotic Disorders; Obesity; Health Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Limitations and Caveats

This study was conducted at one VA medical center in an urban, metropolitan area. Sites can vary markedly in contextual factors; There was a large proportion of overweight patients with SMI who declined to participate.

Results Point of Contact

• Title: Dr. Alexander S. Young
• Organization: VA Greater Los Angeles Healthcare System, Los Angeles, CA

alexander.young@va.gov

310-794-7219

Study Officials

• Alexander S Young, MD MSHS

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: February 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)