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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00344500
First received: June 22, 2006
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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 WLA VA hospital.


Condition Intervention
Diabetes
Obesity
Weight Gain
Behavioral: Behavioral Weight Loss Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Antipsychotic Medication Associated Obesity

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Usual Care
Active Comparator: Arm 2
Weight management education and counseling
Behavioral: Behavioral Weight Loss Program

Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient

  • Be given a 7% weight loss goal
  • Be assisted in obtaining a 500 calorie reduction per day
  • Exercise for at least 30 min/day, at least 5 days a week
  • Maintain weekly food and exercise diaries
  • Be quizzed on their knowledge of healthy eating habits and nutrition
Other Name: Lifestyle Balance Program

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 the WLA 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344500

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Donna Ames, MD VA Greater Los Angeles Healthcare System, West LA
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00344500     History of Changes
Other Study ID Numbers: D3925-R
Study First Received: June 22, 2006
Last Updated: October 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Antipsychotic
Bipolar
Diabetes
Mental Illness
Nutrition
Obesity
Schizoaffective
Schizophrenia
Weight Gain
Weight Loss

Additional relevant MeSH terms:
Body Weight
Obesity
Weight Gain
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014