N/A N=121 Randomized Single-blind Treatment

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

Diabetes · Obesity · Weight Gain

Bottom Line

View on ClinicalTrials.gov: NCT01052714 ↗

Enrolled (actual)

121

Serious AEs

10.9%

Results posted

Oct 2017

Primary outcome: Primary: Mean Weight Change Per Week From Baseline to Termination — 0.133; -0.0756 Pounds per week — p=<.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lifestyle Balance (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Weight Change Per Week From Baseline to Termination	0.133; -0.0756	<.001 sig
PRIMARY Mean Waist Circumference Change Per Week From Baseline to Termination	-0.011; -0.016	0.718
PRIMARY Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination	0.035; -0.009	<.001 sig
PRIMARY Mean Serum Insulin Level Change Per Week From Baseline to Termination	-0.018; -0.44	0.676
PRIMARY Mean Triglycerides Level Change Per Week From Baseline to Termination	5.13; -0.2	0.141
PRIMARY Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination	-0.031; 0.218	0.92
PRIMARY Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination	0.459; 0.056	0.322
PRIMARY Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination	0.02; 0.01	0.652
PRIMARY Change in Mean Total Calories Consumed Per Week From Baseline to Termination	-12.3; -6.8	0.663
PRIMARY Change in Mean Empty Calories Consumed Per Week From Baseline to Termination	-3.02; -4.53	0.9
PRIMARY Change in Mean Total Exercise Time Per Week From Baseline to Termination	0.84; 0.18	0.415
PRIMARY Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination	-0.009; -0.006	0.687
PRIMARY WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination	0.037; 0.013	0.22
PRIMARY WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination	0.027; -0.002	0.059
PRIMARY WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination	0.005; 0.008	0.79
PRIMARY WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination	0.03; 0	0.146
PRIMARY Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination	-0.005; -0.002	<.001 sig
PRIMARY Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination	-0.09; -0.11	0.763

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01052714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.