Prevention of Weight Gain in Early Psychoses
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|ClinicalTrials.gov Identifier: NCT01075295|
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophreniform Disorder Bipolar I Disorder Bipolar II Disorder Major Depressive Disorder Substance-Induced Psychoses Psychosis Not Otherwise Specified Schizophrenia Schizoaffective Disorder||Behavioral: Behavioural Intervention for the Prevention of Weight Gain Other: TAU||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Weight Gain in Early Psychoses|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
|Experimental: Lifestyle Intervention||
Behavioral: Behavioural Intervention for the Prevention of Weight Gain
The intervention consists of four steps:
|Active Comparator: TAU||
Treatment as provided by individuals' existing healthcare providers
- Weight [ Time Frame: Measured at week 0, 4, 8 and 16 ]The proportion with an increase in weight (2% or greater), from baseline to end point.
- Laboratory parameters [ Time Frame: Measured at week 0 and 16 ]
- Fasting glucose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075295
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Rohan Ganguli, MD||Centre for Addiction and Mental Health|