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):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00344500
First received: June 22, 2006
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
This program aims to help Veterans who take antipsychotic medications lose weight. The investigators use a program based on the American Diabetes Association's "Diabetes Prevention Program," and the investigators 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 West Los Angeles 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 VA Office of Research and Development:

Primary Outcome Measures:
  • Mean Weight [ Time Frame: Weekly/Monthly, up to 1 year ] [ Designated as safety issue: No ]
    Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.

  • Change in Predicted Trajectory of Mean BMI Per GLMM Analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.

  • Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.


Enrollment: 122
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: Usual Care
Usual Care
Active Comparator: Lifestyle Balance
Behavioral Weight Loss Program
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   (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 the West Los Angeles 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 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: NCT00344500     History of Changes
Other Study ID Numbers: D3925-R 
Study First Received: June 22, 2006
Results First Received: April 3, 2015
Last Updated: March 8, 2016
Health Authority: United States: Federal Government

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 August 22, 2016