Completed

NCT Number: NCT01052714

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

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.

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Key information

Conditions

Diabetes Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Gain Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Balance

Behavioral

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 names: Lifestyle Balance Program

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Management of Antipsychotic Medication Associated Obesity - 2

Acronym: MAMAO2

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jan 20, 2010
Registry last updated: Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed