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

June 15, 2016 updated by: Margaret Hahn, Centre for Addiction and Mental Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 52 weeks
52 weeks
HbA1c levels
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Diabetes Association

Investigators

  • Principal Investigator: Margaret K Hahn, M.D., Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151/2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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