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

NCT01052714 | Completed Results DMC

• 1 other identifier: D7358-R
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes; Obesity; Weight Gain

Keywords

Antipsychotic; Bipolar; Diabetes; Mental Illness; Nutrition; Obesity; Schizoaffective; Schizophrenia; Weight Gain; Weight Loss

Outcome Measures

Primary Outcomes (18)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

Usual Care

NO INTERVENTION

Control group with time-matched study visits

Lifestyle Balance

ACTIVE COMPARATOR

Weight management group education and individual counseling

Behavioral: Lifestyle Balance

Usual Care then Lifestyle Balance

OTHER

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

Behavioral: Lifestyle Balance

Interventions

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

Also known as: Lifestyle Balance Program

Lifestyle Balance; Usual Care then Lifestyle Balance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have recently been diagnosed with schizophrenia (less than 1 year)
• Are pregnant or breast feeding a baby
• Have a medically unstable condition

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (4)

• 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.

  PMID: 24534370 BACKGROUND

• 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.

  PMID: 26172565 BACKGROUND

• 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.

  PMID: 28271424 RESULT

• 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.

  PMID: 28885930 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Weight Gain; Mental Disorders; Schizophrenia; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Dr. Donna Ames, Principal Investigator
• Organization: Psychiatry Department at VA Greater Los Angeles Healthcare System

donna.ames@va.gov

310-478-3037

Study Officials

• Donna Ames, MD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 20, 2010
• Study Start: September 1, 2010
• Primary Completion: May 28, 2015
• Study Completion: May 28, 2015
• Last Updated: August 9, 2018
• Results First Posted: October 6, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)