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

This study has been completed.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Margaret Hahn, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01828931
First received: April 9, 2013
Last updated: June 15, 2016
Last verified: June 2016

April 9, 2013
June 15, 2016
December 2012
May 2015   (final data collection date for primary outcome measure)
  • Weight [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • HbA1c levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01828931 on ClinicalTrials.gov Archive Site
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Lifestyle Intervention for Diabetes and Weight Management in Psychosis
Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • Bipolar I Disorder
  • Substance-induced Psychosis
  • Psychotic Disorders
  • Major Depressive Disorder
  • Behavioral: Lifestyle Intervention
    A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity
  • Other: Usual Care
    Care as usual
  • Active Comparator: Usual Care
    Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists.
    Intervention: 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.
    Intervention: Behavioral: Lifestyle Intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01828931
151/2012
No
Undecided
Not Provided
Margaret Hahn, Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Canadian Diabetes Association
Principal Investigator: Margaret K Hahn, M.D. Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP