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

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ClinicalTrials.gov Identifier: NCT01828931
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Margaret Hahn, Centre for Addiction and Mental Health

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Weight [ Time Frame: 52 weeks ]
  2. HbA1c levels [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828931


Locations
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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
Investigators
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Principal Investigator: Margaret K Hahn, M.D. Centre for Addiction and Mental Health
More Information
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Responsible Party: Margaret Hahn, Staff Psychiatrist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01828931    
Other Study ID Numbers: 151/2012
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Disease
Psychoses, Substance-Induced
Schizophrenia
Depressive Disorder
Depressive Disorder, Major
Psychotic Disorders
Mental Disorders
Shared Paranoid Disorder
 Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Poisoning
Chemically-Induced Disorders
Substance-Related Disorders