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Lifestyle Intervention for Diabetes and Weight Management in Psychosis (Healthy_LIFE)

This study has been completed.
Canadian Diabetes Association
Information provided by (Responsible Party):
Margaret Hahn, Centre for Addiction and Mental Health Identifier:
First received: April 9, 2013
Last updated: June 15, 2016
Last verified: June 2016
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 Intervention
Type 2 Diabetes Mellitus
Schizoaffective Disorder
Schizophreniform Disorder
Bipolar I Disorder
Substance-induced Psychosis
Psychotic Disorders
Major Depressive Disorder
Behavioral: Lifestyle Intervention
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis

Resource links provided by NLM:

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Weight [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • HbA1c levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: December 2012
Study Completion Date: November 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01828931

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Diabetes Association
Principal Investigator: Margaret K Hahn, M.D. Centre for Addiction and Mental Health
  More Information

Responsible Party: Margaret Hahn, Staff Psychiatrist, Centre for Addiction and Mental Health Identifier: NCT01828931     History of Changes
Other Study ID Numbers: 151/2012 
Study First Received: April 9, 2013
Last Updated: June 15, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Depressive Disorder
Depressive Disorder, Major
Psychotic Disorders
Mental Disorders
Shared Paranoid Disorder
Psychoses, Substance-Induced
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Behavioral Symptoms
Chemically-Induced Disorders
Substance-Related Disorders processed this record on October 20, 2016