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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01052714
First received: January 15, 2010
Last updated: August 10, 2016
Last verified: August 2016
  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 Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.

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 - 2

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2016 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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 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
  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: NCT01052714

Locations
United States, California
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Donna Ames, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01052714     History of Changes
Other Study ID Numbers: D7358-R 
Study First Received: January 15, 2010
Last Updated: August 10, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Antipsychotic
Bipolar
Diabetes
Mental Illness
Nutrition
Obesity
Schizoaffective
Schizophrenia
Weight Gain
Weight Loss

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

ClinicalTrials.gov processed this record on December 02, 2016