Prevention of Weight Gain in Early Psychoses

NCT01075295 | Completed

• 1 other identifier: 133/2009
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Schizophreniform Disorder; Schizophrenia, Schizoaffective disorder; Bipolar I Disorder; Bipolar II Disorder; Major Depressive Disorder with Psychotic Features,; Substance-Induced Psychoses; Psychosis Not Otherwise Specified; antipsychotic; weight gain; body mass index; BMI; waist circumference; WC; coronary heart disease; CHD

Outcome Measures

Primary Outcomes (1)

• Weight

  The proportion with an increase in weight (2% or greater), from baseline to end point.

  Measured at week 0, 4, 8 and 16

Secondary Outcomes (1)

• Laboratory parameters

  Measured at week 0 and 16

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

Behavioral: Behavioural Intervention for the Prevention of Weight Gain

TAU

ACTIVE COMPARATOR

Other: TAU

Interventions

Behavioural Intervention for the Prevention of Weight Gain BEHAVIORAL

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)

Lifestyle Intervention

TAU OTHER

Treatment as provided by individuals' existing healthcare providers

TAU

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 14 and 45 years (inclusive)
• Male or Female gender
• DSM-IV-TR diagnosis of 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)
• Outpatient status at the time of randomization
• Duration of antipsychotic treatment of less than 5 years
• Ability to provide informed consent
• Female patients of childbearing potential must be using a medically accepted means of contraception
• Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment
• BMI between 18.5 and 30

You may not qualify if:

• Inability to give informed consent
• Currently enrolled in a weight management program
• Currently being treated with a medication to reduce weight
• Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre.

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major; Psychoses, Substance-Induced; Schizophrenia; Weight Gain; Coronary Disease

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Poisoning; Chemically-Induced Disorders; Substance-Related Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Rohan Ganguli, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

CA (1)