Prevention of Weight Gain in Early Psychoses

Summary

The purpose of this study is to determine whether individuals with psychotic spectrum disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II),Major Depressive Disorder With Psychotic Features,Substance-Induced Psychoses,Psychosis Not-Otherwise-Specified (NOS)randomly assigned to a stepped behavioral intervention for the prevention of weight gain will experience less weight gain than individuals who receive usual care. There are several studies that have examined the effect of pharmacological and non-pharmacological behavioural approaches for weight loss in patients with psychosis, however studies examining strategies for prevention of obesity are lacking. This study is an important and novel approach to studying the problem of obesity in those with psychosis.

Conditions

• Schizophreniform Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Major Depressive Disorder
• Substance-Induced Psychoses
• Psychosis Not Otherwise Specified
• Schizophrenia
• Schizoaffective Disorder

Interventions

BEHAVIORAL

Behavioural Intervention for the Prevention of Weight Gain

The intervention consists of four steps: * STEP 1 (Watchful Waiting): Measurement of body weight and Waist Circumference at the start (1 visit). Subjects that have a weight gain greater then or equal to 2% of their baseline weight will progress to Step 2 * STEP 2 (Self monitoring): Self-monitoring of daily weight, daily food intake \& physical activity (1 visit) Subjects that have a weight gain greater then or equal to 2% (from STEP 2) will progress to Step 3 * STEP 3 (Nutrition \& Exercise Counseling): Counseling for nutrition and physical activity (4 visits; 2 in-clinic, 2 telephone) Subjects that have a weight gain greater then or equal to 2% (from STEP 3) will progress to Step 4 * STEP 4 (Intensive): Intensive behavioral training geared towards reducing caloric intake (4 in-clinic visits)

OTHER

TAU

Treatment as provided by individuals' existing healthcare providers

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Rohan Ganguli, MD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• Canada

Study Locations