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

This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00983476
First received: September 22, 2009
Last updated: March 8, 2013
Last verified: March 2013

September 22, 2009
March 8, 2013
March 2012
May 2014   (final data collection date for primary outcome measure)
BMI, self-efficacy, motivation, readiness to change, dietary habits, physical activity, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
BMI, self-efficacy, motivation, readiness to change, dietary habits, physical activity, health related functioning, quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00983476 on ClinicalTrials.gov Archive Site
  • health related functioning, quality of life, psychopathology, satisfaction and usability of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • qualitative assessment of satisfaction, usability, strengths, weaknesses, barriers of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • psychopathology, satisfaction and usability of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • qualitative assessment of satisfaction, usability, strengths, weaknesses, barriers of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)
Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness

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.

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) have developed a prototype web-based system that provides computerized counseling regarding diet to individuals with SMI. The proposed project expands 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 has developed the needed materials, methods, and informatics systems. Patients are being enrolled, and the interventions evaluated.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Psychotic Disorders
  • Obesity
  • Health Behaviors
  • Behavioral: in-person MOVE! SMI
    Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
  • Behavioral: web-based MOVE! SMI
    online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
  • Experimental: Arm 1
    in-person MOVE! SMI
    Intervention: Behavioral: in-person MOVE! SMI
  • Experimental: Arm 2
    web-based MOVE! SMI
    Intervention: Behavioral: web-based MOVE! SMI
  • No Intervention: Arm 3
    usual care + educational handouts regarding weight loss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
345
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. any medical condition for which a weight program is contraindicated;
  2. history of bariatric surgery;
  3. pregnant and nursing mothers;
  4. a diagnosis of dementia or a Mini-Mental Status Examination score of 23 or less;
  5. not able to provide informed consent.
Both
18 Years and older
No
Contact: Dawn L Glover, MA (310) 478-3711 ext 48338 Dawn.Glover@va.gov
Contact: Rebecca S Shoai, MPH (310) 478-3711 ext 38165 rebecca.shoai@va.gov
United States
 
NCT00983476
IIR 09-083
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Alexander S. Young, MD MSHS VA Greater Los Angeles Health Care System
Department of Veterans Affairs
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP