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

Obesity Clinical Trial

— MAMAO2  

Official title:

Management of Antipsychotic Medication Associated Obesity - 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052714
• Other study ID #: D7358-R
• Status: Completed
• Phase: N/A
• Start date: September 1, 2010
• Est. completion date: May 28, 2015

Study information

• Verified date: July 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 28, 2015
• Est. primary completion date: May 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes
• Obesity
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
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	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Veter — View 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. — View Citation

Kwan CL, Gelberg HA, 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):369-74. doi: 10.1016/j.jand.2013.12.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Primary	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.	Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Primary	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.	Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Primary	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.	Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Primary	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.	Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Primary	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.	Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Primary	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.	Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Primary	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.	Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Primary	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.	Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Primary	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.	Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Primary	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.	Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.