Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    NCT01585493
Previous Study | Return to List | Next Study

CHANGE -it is About Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585493
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : October 27, 2016
University of Copenhagen
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Brief Summary:

Schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. Recently, a large register-based study, involving complete national data from Denmark, Sweden and Finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. Patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.Results from the Danish National Indicator Project for Schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values.

In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. We will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the CHANGE team who should facilitate life style changes and contact with general practice. The objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Metabolic Syndrome Other: Treatment as usual Behavioral: Care coordinator Behavioral: CHANGE Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Study Start Date : December 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Treatment as usual
Treatment as usual
Other: Treatment as usual
Treatment as usual. Patients will be affiliated with local out-patient clinics in secondary mental health services and they will have access to their own general practitioner. No formalized extra effort will be made to ensure treatment of physical disorders.Patients will be affiliated with local out-patient clinics in secondary

Active Comparator: Care coordinator Behavioral: Care coordinator
Treatment as usual plus a care coordinator (with a caseload of 25 patients) who will facilitate contact to primary care in order to ensure treatment of physical health problems,

Experimental: CHANGE Behavioral: CHANGE

Treatment as usual plus affiliation to a staffmember (caseload 10) from a CHANGE team who will provide individualized, adjusted implementation of widely recognized interventions, such as smoking cessation programmes, motivational interviewing, psychoeducation plus patient involvement in monitoring health statusA multidisciplinary CHANGE team will be established. Team members will be health professionals with experience in smoking cessation programmes or exercise programmes for mentally ill, and experts with competence in dietary issues.

CHANGE treatment involve lifestyle coaching, education about diet and physical activity,16 networking and smoking cessation programs. The team members will act as lifestyle coaches for ten patients at a time, map lifestyle and explore and elicit patients' motivation for change.

Primary Outcome Measures :
  1. Copenhagen Risk Score [ Time Frame: 12 months ]
    The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.

Secondary Outcome Measures :
  1. Smoking [ Time Frame: 12 months ]
    Number of daily smokers in each group at 12 months

  2. Sedentary lifestyle [ Time Frame: 12 ]
    Self reported hours of sedentary behavior

  3. Body mass index [ Time Frame: 12 months ]
    Change in body mass index at 12 months

  4. Blood pressure [ Time Frame: 12 months ]
    Change in systolic and diastolic blood pressure at 12 months

  5. Cholesterol [ Time Frame: 12 months ]
    Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months

  6. Aerobic fitness [ Time Frame: 12 months ]
    Indirectly estimated maximal oxygen uptake

  7. Waist circumference [ Time Frame: 12 months ]
    Measured between crista iliaca and the lowest rib

  8. Forced expiratory volume [ Time Frame: 12 months ]
  9. Resting heart rate [ Time Frame: 12 months ]
  10. HbA1c [ Time Frame: 12 months ]
  11. Physical activity [ Time Frame: 12 months ]
    Change in minutes of MVPA a week

Other Outcome Measures:
  1. Positive and negative symptoms [ Time Frame: 12 months ]
  2. Cognition [ Time Frame: 12 months ]
  3. Quality of life [ Time Frame: 12 months ]
  4. Dietary pattern [ Time Frame: 12 months ]
  5. Self rated health [ Time Frame: 12 months ]
  6. High sensitive CRP [ Time Frame: 12 months ]
  7. Triglycerides [ Time Frame: 12 months ]
  8. Global assessment functioning (GAF) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01585493

Layout table for location information
Mental Health Services in the Capital Region, Denmark
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
Layout table for investigator information
Principal Investigator: Merete Nordentoft, Professor Mental Health Centre Copenhagen
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mental Health Services in the Capital Region, Denmark Identifier: NCT01585493    
Other Study ID Numbers: Change
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by Mental Health Services in the Capital Region, Denmark:
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases