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

Primary Purpose

Diabetes, Obesity, Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Balance
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia, Weight Gain, Weight Loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Long Beach Healthcare System, Long Beach, CA
  • VA Greater Los Angeles Healthcare System, Sepulveda, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Other

Arm Label

Usual Care

Lifestyle Balance

Usual Care then Lifestyle Balance

Arm Description

Control group with time-matched study visits

Weight management group education and individual counseling

Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.

Outcomes

Primary Outcome Measures

Mean Weight Change Per Week From Baseline to Termination
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2010
Last Updated
July 12, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01052714
Brief Title
Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2
Acronym
MAMAO2
Official Title
Management of Antipsychotic Medication Associated Obesity - 2
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
May 28, 2015 (Actual)
Study Completion Date
May 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Obesity, Weight Gain
Keywords
Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia, Weight Gain, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Control group with time-matched study visits
Arm Title
Lifestyle Balance
Arm Type
Active Comparator
Arm Description
Weight management group education and individual counseling
Arm Title
Usual Care then Lifestyle Balance
Arm Type
Other
Arm Description
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Balance
Other Intervention Name(s)
Lifestyle Balance Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Weight Change Per Week From Baseline to Termination
Description
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
Time Frame
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Title
Mean Waist Circumference Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Title
Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Title
Mean Serum Insulin Level Change Per Week From Baseline to Termination
Description
Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.
Time Frame
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Title
Mean Triglycerides Level Change Per Week From Baseline to Termination
Description
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Time Frame
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Title
Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
Description
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Time Frame
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Title
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Description
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Time Frame
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Title
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
Title
Change in Mean Total Calories Consumed Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Title
Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Title
Change in Mean Total Exercise Time Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Title
Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Title
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Title
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Title
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Title
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
Description
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.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Title
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
Description
Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Title
Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
Description
Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.
Time Frame
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Ames, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System, Long Beach, CA
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, Sepulveda, CA
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24534370
Citation
Kwan CL, Gelberg HAL, Rosen JA, Chamberlin V, Shah C, Nguyen C, Pierre JM, Erickson ZD, Mena SJ, King M Jr, Arnold I, Baker MR, Meyer HB, Ames D. Nutritional counseling for adults with severe mental illness: key lessons learned. J Acad Nutr Diet. 2014 Mar;114(3):369-374. doi: 10.1016/j.jand.2013.12.005. No abstract available.
Results Reference
background
PubMed Identifier
26172565
Citation
Gelberg HA, Kwan CL, Mena SJ, Erickson ZD, Baker MR, Chamberlin V, Nguyen C, Rosen JA, Shah C, Ames D. Meal replacements as a weight loss tool in a population with severe mental illness. Eat Behav. 2015 Dec;19:61-4. doi: 10.1016/j.eatbeh.2015.06.009. Epub 2015 Jul 2.
Results Reference
background
PubMed Identifier
28271424
Citation
Erickson ZD, Kwan CL, Gelberg HA, Arnold IY, Chamberlin V, Rosen JA, Shah C, Nguyen CT, Hellemann G, Aragaki DR, Kunkel CF, Lewis MM, Sachinvala N, Sonza PA, Pierre JM, Ames D. A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity. J Gen Intern Med. 2017 Apr;32(Suppl 1):32-39. doi: 10.1007/s11606-016-3960-3.
Results Reference
result
PubMed Identifier
28885930
Citation
Tessier JM, Erickson ZD, Meyer HB, Baker MR, Gelberg HA, Arnold IY, Kwan C, Chamberlin V, Rosen JA, Shah C, Hellemann G, Lewis MM, Nguyen C, Sachinvala N, Amrami B, Pierre JM, Ames D. Therapeutic Lifestyle Changes: Impact on Weight, Quality of Life, and Psychiatric Symptoms in Veterans With Mental Illness. Mil Med. 2017 Sep;182(9):e1738-e1744. doi: 10.7205/MILMED-D-16-00405.
Results Reference
derived

Learn more about this trial

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

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