Healthy_LIFE: Lifestyle Intervention for Diabetes and Weight Management in Psychosis

Sponsor

Centre for Addiction and Mental Health (Other)

Overall Status

Completed

CT.gov ID

NCT01828931

Collaborator

Canadian Diabetes Association (Other)

120

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Bipolar I Disorder Substance-induced Psychosis Psychotic Disorders Major Depressive Disorder	Behavioral: Lifestyle Intervention Other: Usual Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Usual Care

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

Other: Usual Care

Care as usual

Experimental: Lifestyle Intervention

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

Behavioral: Lifestyle Intervention

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

Outcome Measures

Primary Outcome Measures

Weight [52 weeks]
HbA1c levels [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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