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CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia


Phase 3
18 Years
N/A
Not Enrolling
Both
Schizophrenia, Metabolic Syndrome

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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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