CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Schizophrenia, Metabolic Syndrome
Both
Schizophrenia, Metabolic Syndrome
Trial Information
CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Inclusion Criteria:
- Affiliated to outpatients services at Mental Health Centre, Copenhagen or Århus
University Hospital
- Diagnose ICD-10:F2 spectrum
- Waist circumference > 88 cm for women or >102 cm for men
Exclusion Criteria:
- Not willing to participate
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
HbA1C
Outcome Description:
The primary outcome is HbA1C change from baseline at 12 months. The HbA1C which is a proxy for glucose level withing the last 8 to 12 weeks.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Merete Nordentoft, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mental Health Centre Copenhagen
Authority:
Denmark: National Board of Health
Study ID:
Change
NCT ID:
NCT01585493
Start Date:
December 2012
Completion Date:
August 2016
Related Keywords:
- Schizophrenia
- Metabolic Syndrome
- Lifestyle
- Smoking
- Dietary
- Exercise
- Schizophrenia
- Metabolic Syndrome X
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