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

Not Applicable

Completed

• Conditions: Obesity; Weight Gain; Diabetes
• Interventions: Behavioral: Lifestyle Balance

• Registration Number: NCT01052714
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-20
• Study Start: 2010-09-01
• Primary Completion: 2015-05-28
• Study Completion: 2015-05-28
• Results First Submitted: 2017-07-11
• Results First Submitted QC: 2017-09-07
• Results First Posted: 2017-10-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual Care then Lifestyle Balance	Lifestyle Balance	Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
Lifestyle Balance	Lifestyle Balance	Weight management group education and individual counseling

Primary Outcome Measures

Name	Time	Method
Mean Serum Insulin Level Change Per Week From Baseline to Termination	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	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	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.
Change in Mean Total Exercise Time Per Week From Baseline to Termination	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	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.
Mean Weight Change Per Week From Baseline to Termination	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 Body Mass Index (BMI) Change Per Week From Baseline to Termination	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.
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination	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.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination	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	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.
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination	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.
Change in Mean Total Calories Consumed Per Week From Baseline to Termination	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	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.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination	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.
Mean Waist Circumference Change Per Week From Baseline to Termination	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.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination	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.
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination	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	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.

Trial Locations

Locations (3)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA; 🇺🇸 West Los Angeles, California, United States

VA Long Beach Healthcare System, Long Beach, CA; 🇺🇸 Long Beach, California, United States

VA Greater Los Angeles Healthcare System, Sepulveda, CA; 🇺🇸 Sepulveda, California, United States