NCT01828931

Lifestyle Intervention for Diabetes and Weight Management in Psychosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder
• Bipolar I Disorder
• Substance-induced Psychosis
• Psychotic Disorders
• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Intervention	A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity
OTHER	Usual Care	Care as usual

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-05-01
• Completion: 2015-11-01
• First posted: 2013-04-11
• Last updated: 2016-06-17

Locations

1 site across 1 country: Canada