| Conditions: |
|
Psychotic Disorders - Obesity - Health Behaviors |
| 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.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
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.
|
| NCT ID: |
|
NCT00983476 |
| Primary Contact: |
|
Principal Investigator
Alexander S. Young, MD MSHS
VA Greater Los Angeles Health Care System
Dawn L Glover, MA
Phone: (310) 478-3711 ext. 48338
Email: Dawn.Glover@va.gov
|
| Backup Contact: |
|
Email: rebecca.shoai@va.gov
Rebecca S Shoai, MPH
Phone: (310) 478-3711 ext. 38165
|
| Location Contact: |
|
West Los Angeles, California 90073
United States
Ismelda A Canelo, MPA
Phone: 818-891-7711
Email: Ismelda.Canelo@va.gov
Site Status: Recruiting |