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Lifestyle Intervention for Diabetes and Weight Management in Psychosis (Healthy LIFE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Rohan Ganguli, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01828931
First received: April 9, 2013
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Bipolar I Disorder
Major Depression With Psychotic Features
Substance-induced Psychosis
Psychosis Not Otherwise Specified
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 ]

Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Primary Completion Date: December 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828931

Locations
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
Principal Investigator: Rohan Ganguli, M.D. Centre for Addiction and Mental Health
  More Information

No publications provided

Responsible Party: Rohan Ganguli, Canada Research Chair; Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01828931     History of Changes
Other Study ID Numbers: 151/2012
Study First Received: April 9, 2013
Last Updated: November 6, 2014
Health Authority: Canada: Centre for Addiction and Mental Health Research Ethics Board

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Diabetes Mellitus
Diabetes Mellitus, Type 2
Disease
Mental Disorders
Psychoses, Substance-Induced
Psychotic Disorders
Schizophrenia
Shared Paranoid Disorder
Behavioral Symptoms
Chemically-Induced Disorders
Depressive Disorder
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Mood Disorders
Pathologic Processes
Poisoning
Schizophrenia and Disorders with Psychotic Features
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 20, 2014