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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:
ClinicalTrials.gov Identifier:
NCT01052714
First Posted: January 20, 2010
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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: Lifestyle Balance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Masking Description:
Investigator performed ratings of participants while masked to their randomized treatment assignment.
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:
  • Mean Weight Change Per Week From Baseline to Termination [ Time Frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. ]
    Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.

  • Mean Waist Circumference Change Per Week From Baseline to Termination [ Time Frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. ]
    Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.

  • Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination [ Time Frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. ]
    Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.

  • Mean Serum Insulin Level Change Per Week From Baseline to Termination [ Time Frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. ]
    Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.

  • Mean Triglycerides Level Change Per Week From Baseline to Termination [ Time Frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. ]
    Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.

  • Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination [ Time Frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. ]
    Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.

  • Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination [ Time Frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. ]
    Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.

  • Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months. ]
    Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.

  • Change in Mean Total Calories Consumed Per Week From Baseline to Termination [ Time Frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. ]
    Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.

  • Change in Mean Empty Calories Consumed Per Week From Baseline to Termination [ Time Frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. ]
    Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.

  • Change in Mean Total Exercise Time Per Week From Baseline to Termination [ Time Frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. ]
    Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.

  • Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.

  • WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.

  • WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.

  • WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.

  • WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.

  • Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.

  • Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination [ Time Frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. ]
    Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.


Enrollment: 121
Actual Study Start Date: September 1, 2010
Estimated Study Completion Date: September 2018
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Control group with time-matched study visits
Active Comparator: Lifestyle Balance
Weight management group education and individual counseling
Behavioral: Lifestyle Balance
Patients assigned 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
Usual Care then Lifestyle Balance
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
Behavioral: Lifestyle Balance
Patients assigned 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052714


Locations
United States, California
Tibor Rubin VA Medical Center
Long Beach, California, United States, 90822
Los Angeles Ambulatory Care Center
Los Angeles, California, United States, 90012
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
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] September 6, 2017

  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01052714     History of Changes
Other Study ID Numbers: D7358-R
First Submitted: January 15, 2010
First Posted: January 20, 2010
Results First Submitted: July 11, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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