Lifestyle Intervention for Diabetes and Weight Management in Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-11-30

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.

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Detailed Description

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Care as usual

Lifestyle Intervention

A lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity

Interventions

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Lifestyle Intervention

A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity

Intervention Type BEHAVIORAL

Usual Care

Care as usual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 18 and 70 years (inclusive)
2. DSM-IV-TR diagnosis of one of the psychotic disorders listed above
3. Body Mass Index (BMI) \> 25 kg/m2 at the time of enrollment
4. Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes
5. Ability to provide informed consent
6. No medical contraindication to participation in weight reduction / exercise program, determined in consultation with their primary care physician
7. Female participants, of childbearing potential, using a medically accepted means of contraception

Exclusion Criteria

1. Inability to give informed consent
2. Currently enrolled in a formal structured weight management program
3. Currently being prescribed medication specifically for weight loss
4. Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc.
5. Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No