Lifestyle Intervention for Diabetes and Weight Management in Psychosis

Schizophrenia Clinical Trial

— Healthy_LIFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828931
• Other study ID #: 151/2012
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: June 15, 2016
• Start date: December 2012
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Diabetes Mellitus, Type 2
• Disease
• Major Depressive Disorder
• Mental Disorders
• Psychoses, Substance-Induced
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder
• Substance-induced Psychosis
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle Intervention
A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity

Other:
• Usual Care
Care as usual

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		52 weeks	No
Primary	HbA1c levels		52 weeks	No