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

Primary Purpose

Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle Intervention
Usual Care
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Lifestyle Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight
HbA1c levels

Secondary Outcome Measures

Full Information

First Posted
April 9, 2013
Last Updated
June 15, 2016
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01828931
Brief Title
Lifestyle Intervention for Diabetes and Weight Management in Psychosis
Acronym
Healthy_LIFE
Official Title
Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar I Disorder, Substance-induced Psychosis, Psychotic Disorders, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists.
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
A lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Care as usual
Primary Outcome Measure Information:
Title
Weight
Time Frame
52 weeks
Title
HbA1c levels
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret K Hahn, M.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Lifestyle Intervention for Diabetes and Weight Management in Psychosis

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