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Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)

VA Office of Research and Development logo

VA Office of Research and Development

Status

Completed

Conditions

Diabetes
Weight Gain
Obesity

Treatments

Behavioral: Lifestyle Balance

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01052714
D7358-R

Details and patient eligibility

About

This program aims to help Veterans who take antipsychotic medications lose weight. We use a program based on the American Diabetes Association's "Diabetes Prevention Program," and we have modified it to fit the lifestyles of people with mental illness. All participants are educated about nutrition and cutting down fat intake, how and when to exercise, and the causes of diabetes and how to prevent it. Participants must be Veterans who live within one hour of the Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.

Enrollment

121 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must be a Veteran
  • Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
  • Age 18-70
  • Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
  • Experienced weight gain since treatment with SGA's
  • Inpatient or outpatient at Long Beach, West Los Angeles, Sepulveda, or Downtown VA
  • Competent to sign informed consent

Exclusion criteria

  • Have recently been diagnosed with schizophrenia (less than 1 year)
  • Are pregnant or breast feeding a baby
  • Have a medically unstable condition

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

121 participants in 3 patient groups

Usual Care
No Intervention group
Description:
Control group with time-matched study visits
Lifestyle Balance
Active Comparator group
Description:
Weight management group education and individual counseling
Treatment:
Behavioral: Lifestyle Balance
Usual Care then Lifestyle Balance
Other group
Description:
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
Treatment:
Behavioral: Lifestyle Balance

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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