Prevention of Weight Gain in Early Psychoses
Condition: Schizophreniform Disorder; Bipolar I Disorder; Bipolar II Disorder; Major Depressive Disorder; Substance-Induced Psychoses; Psychosis Not Otherwise Specified; Schizophrenia; Schizoaffective Disorder
MeSH terms: Weight Gain; Psychoses, Substance-Induced; Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Psychotic Disorders; Mental Disorders; Shared Paranoid Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): Behavioural Intervention for the Prevention of Weight Gain; TAU
Intervention type(s): Behavioral; Other
Intervention description(s): 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); Treatment as provided by individuals' existing healthcare providers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
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