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

NCT00344500 | Completed Results DMC

• 1 other identifier: D3925-R
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This program aims to help Veterans who take antipsychotic medications lose weight. The investigators use a program based on the American Diabetes Association's "Diabetes Prevention Program," and the investigators 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 West Los Angeles VA hospital.

Conditions

Diabetes; Obesity; Weight Gain

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Mean Weight

  Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.

  Weekly/Monthly, up to 1 year

• Change in Predicted Trajectory of Mean BMI Per GLMM Analysis

  General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.

  12 months

• Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis

  Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.

  12 months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual Care

Lifestyle Balance

ACTIVE COMPARATOR

Behavioral Weight Loss Program

Behavioral: Behavioral Weight Loss Program

Interventions

Behavioral Weight Loss Program BEHAVIORAL

Patients randomized 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

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 the West Los Angeles 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 (1)

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

West Los Angeles, California, 90073, United States

Location

Related Publications (3)

• Guzik LH, Wirshing DA. Behavioral weight loss classes for patients with severe mental illness. Psychiatr Serv. 2007 Nov;58(11):1498. doi: 10.1176/ps.2007.58.11.1498. No abstract available.

  PMID: 17978266 BACKGROUND

• Erickson ZD, Mena SJ, Pierre JM, Blum LH, Martin E, Hellemann GS, Aragaki DR, Firestone L, Lee C, Lee P, Kunkel CF, Ames D. Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. J Clin Psychiatry. 2016 Feb;77(2):e183-9. doi: 10.4088/JCP.14m09552.

  PMID: 26930534 RESULT

• Tully A, Smyth S, Conway Y, Geddes J, Devane D, Kelly JP, Jordan F. Interventions for the management of obesity in people with bipolar disorder. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013006. doi: 10.1002/14651858.CD013006.pub2.

  PMID: 32687629 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

Limitations and Caveats

Limitations to our study were its single-site recruitment yielding subjects mostly male and all veterans, limiting of statistical power by control subjects allowed to join treatment group resulting in exclusion from data, and a high dropout rate.

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 26, 2006
• Study Start: October 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 6, 2016
• Results First Posted: May 18, 2015

Record last verified: 2016-03

Locations

US (1)