CHANGE -it is About Life

This study is not yet open for participant recruitment.
Verified February 2012 by Mental Health Services in the Capital Region, Denmark
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier:
NCT01585493
First received: March 27, 2012
Last updated: November 27, 2012
Last verified: February 2012

March 27, 2012
November 27, 2012
December 2012
August 2016   (final data collection date for primary outcome measure)
  • HbA1C [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • Waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline at 12 months
Same as current
Complete list of historical versions of study NCT01585493 on ClinicalTrials.gov Archive Site
  • Smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of daily smokers in each group at 12 months
  • Sedentary lifestyle [ Time Frame: 12 ] [ Designated as safety issue: No ]
    Number of participants classified as having sedentary lifestyle, using questionnaires (Inter 99 study)
  • Body mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in body mass index at 12 months
  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in systolic and diastolic blood pressure at 12 months
  • Cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months
  • Dietary intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The investigators will assess change in the last weeks diatary intake of fibres, fat, fish, fruit, vegetables at 12 months using questionnaires (Inter 99 study)
  • Physical self-perception profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The investigators will assess change in physical self-perception profile at 12 months, using the PSPP questionnaire
Same as current
Not Provided
Not Provided
 
CHANGE -it is About Life
CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Schizophrenia
  • Metabolic Syndrome
  • 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
  • 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,
  • 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.

  • Active Comparator: Treatment as usual
    Treatment as usual
    Intervention: Other: Treatment as usual
  • Active Comparator: Care coordinator
    Intervention: Behavioral: Care coordinator
  • Experimental: CHANGE
    Intervention: Behavioral: CHANGE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
450
August 2016
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Merete Nordentoft, Professor +45 35316682 mn@dadlnet.dk
Denmark
 
NCT01585493
Change
No
Mental Health Services in the Capital Region, Denmark
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
Principal Investigator: Merete Nordentoft, Professor Mental Health Centre Copenhagen
Mental Health Services in the Capital Region, Denmark
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP