Lifestyle Intervention for Diabetes and Weight Management in Psychosis (Healthy_LIFE)
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ClinicalTrials.gov Identifier: NCT01828931 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : June 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Mellitus Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Bipolar I Disorder Substance-induced Psychosis Psychotic Disorders Major Depressive Disorder | Behavioral: Lifestyle Intervention Other: Usual Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | November 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Usual Care
Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists.
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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.
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Behavioral: Lifestyle Intervention
A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity |
- Weight [ Time Frame: 52 weeks ]
- HbA1c levels [ Time Frame: 52 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828931
Canada, Ontario | |
Centre for Addiction and Mental Health | |
Toronto, Ontario, Canada, M6J 1H4 |
Principal Investigator: | Margaret K Hahn, M.D. | Centre for Addiction and Mental Health |
Responsible Party: | Margaret Hahn, Staff Psychiatrist, Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT01828931 |
Other Study ID Numbers: |
151/2012 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | June 17, 2016 |
Last Verified: | June 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Diabetes Mellitus Disease Psychoses, Substance-Induced Schizophrenia Depressive Disorder Depressive Disorder, Major Psychotic Disorders Mental Disorders Shared Paranoid Disorder |
Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Schizophrenia Spectrum and Other Psychotic Disorders Mood Disorders Poisoning Chemically-Induced Disorders Substance-Related Disorders |