Lifestyle Intervention for Diabetes and Weight Management in Psychosis

Not Applicable

Completed

• Conditions: Schizophreniform Disorder; Bipolar I Disorder; Substance-induced Psychosis; Psychotic Disorders; Type 2 Diabetes Mellitus; Schizophrenia; Schizoaffective Disorder; Major Depressive Disorder
• Interventions: Other: Usual Care; Behavioral: Lifestyle Intervention

• Registration Number: NCT01828931
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Primary Completion: 2015-05
• Study Completion: 2015-11
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists.
Lifestyle Intervention	Lifestyle Intervention	A lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits.

Primary Outcome Measures

Name	Time	Method
HbA1c levels	52 weeks
Weight	52 weeks

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada