Prevention of Weight Gain in Early Psychoses

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rohan Ganguli, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01075295
First received: February 23, 2010
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Schizophreniform Disorder
Bipolar I Disorder
Bipolar II Disorder
Major Depressive Disorder With Psychotic Features,
Substance-Induced Psychoses
Psychosis Not Otherwise Specified
Schizophrenia
Schizoaffective Disorder
Behavioral: Behavioural Intervention for the Prevention of Weight Gain
Other: TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Weight Gain in Early Psychoses

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Weight [ Time Frame: Measured at week 0, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The proportion with an increase in weight (2% or greater), from baseline to end point.


Secondary Outcome Measures:
  • Laboratory parameters [ Time Frame: Measured at week 0 and 16 ] [ Designated as safety issue: No ]
    • Fasting glucose
    • Insulin
    • Lipids


Enrollment: 70
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Intervention 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)
Active Comparator: TAU Other: TAU
Treatment as provided by individuals' existing healthcare providers

Detailed Description:

The rates of obesity and related co-morbidities are several-fold higher in patients with psychosis than in the general population. In addition the life expectancy 20% shorter. Several lifestyle and illness-related factors have been implicated for these high rates, including weight gain associated with treatment with novel antipsychotics. The most important cause of death in psychosis patients is coronary heart disease (CHD), of which obesity is a major risk factor. As well, diabetes and its associated complications occur at high rates in persons with psychosis, and diabetes is both related to obesity and is an independent risk factor for CVD and mortality. It therefore seems reasonable to assume that prevention of obesity may lead to a reduced risk for CVD and diabetes. If the proposed intervention proves successful in preventing weight gain and reducing risk for CVD and diabetes, the quality and length of life for persons with psychosis will be vastly improved and medical costs reduced.

Specifically, we hypothesize that : 1a) a smaller proportion of those in the intervention will gain weight (2% or more) as compared to those receiving usual care, 1b) the mean weight gain of those randomized to the intervention will be less than the mean weight gain in those randomized to usual care 2) Increases in Body Mass Index (BMI) and waist circumference (WC) will be smaller in the intervention group as compared to the controls. 3) there will be smaller increases in cholesterol, triglycerides, blood glucose and insulin levels in the intervention group than in the control group. Exploratory analyses of changes in makers for systemic inflammation, and their relationship to weight, and lipid changes, will be conducted to develop novel hypotheses regarding mediators of CVD risk in psychosis.

The study will recruit sixty persons or outpatients with DSM-lV Psychosis with a BMI of < 30 kg/m², who have been treated for less than 2 years (Early SZ) and meet the other enrollment criteria. They will be randomly assigned in the allocation ratio 1:1 to either get a stepped behavioural intervention for prevention of weight gain (n=30) or treatment as usual (routine care, n=30). This will be a pragmatic clinical trial of 16-week duration.

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Inclusion/exclusion criteria has been intentionally limited in order to maximize the generalizability of the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075295

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Rohan Ganguli, MD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Rohan Ganguli, M.D., Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01075295     History of Changes
Other Study ID Numbers: 133/2009
Study First Received: February 23, 2010
Last Updated: December 4, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Centre for Addiction and Mental Health:
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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Psychoses, Substance-Induced
Mental Disorders
Psychotic Disorders
Schizophrenia
Shared Paranoid Disorder
Depressive Disorder, Major
Weight Gain
Mood Disorders
Behavioral Symptoms
Poisoning
Chemically-Induced Disorders
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014