Lifestyle Intervention for Diabetes and Weight Management in Psychosis

Study Overview
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Brief Summary
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The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic illness has been an exclusion criterion in all large-scale studies of diabetes prevention and management. We propose a 3-year randomized controlled trial examining the effectiveness of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM. Weight and glycemic control will be the primary outcome variables. It is hypothesized that a significant weight reduction and improvement in glycemic control will be found in those who receive the LI relative to those who do not.

Official Title
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Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis

Conditions
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Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar I Disorder, Substance-induced Psychosis, Psychotic Disorders, Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Lifestyle Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18 and 70 years (inclusive) DSM-IV-TR diagnosis of one of the psychotic disorders listed above Body Mass Index (BMI) > 25 kg/m2 at the time of enrollment Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes Ability to provide informed consent No medical contraindication to participation in weight reduction / exercise program, determined in consultation with their primary care physician Female participants, of childbearing potential, using a medically accepted means of contraception Exclusion Criteria: Inability to give informed consent Currently enrolled in a formal structured weight management program Currently being prescribed medication specifically for weight loss Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc. Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists. | Other: Usual Care<br>* Care as usual<br>|
| Experimental: Lifestyle Intervention<br>A lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits. | Behavioral: Lifestyle Intervention<br>* A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 52 weeks | 
| HbA1c levels |  | 52 weeks |