Skip to main content
OpenTrials
Completed

NCT Number: NCT01828931

Lifestyle Intervention for Diabetes and Weight Management in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Bipolar I Disorder Depressive Disorder Depressive Disorder, Major Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Major Depressive Disorder Mental Disorders Metabolic Diseases Mood Disorders Nutritional and Metabolic Diseases Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder Substance-induced Psychosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity

Usual Care

Other

Care as usual

Primary outcomes

  1. Weight

    Time frame: 52 weeks

  2. HbA1c levels

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis

Acronym: Healthy_LIFE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2013
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.