Clinical trial NCT01585493: CHANGE -it is About Life
Official title: CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Metabolic Syndrome
Keywords: Lifestyle
Smoking
Dietary
Exercise
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2012-04-26
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Copenhagen Risk Score
timeFrame: 12 months
Secondary outcomes:
measure: Smoking
timeFrame: 12 months
measure: Sedentary lifestyle
timeFrame: 12
measure: Body mass index
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Cholesterol
timeFrame: 12 months
measure: Aerobic fitness
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Forced expiratory volume
timeFrame: 12 months
measure: Resting heart rate
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
Other outcomes:
measure: Positive and negative symptoms
timeFrame: 12 months
measure: Cognition
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Dietary pattern
timeFrame: 12 months
measure: Self rated health
timeFrame: 12 months
measure: High sensitive CRP
timeFrame: 12 months
measure: Triglycerides
timeFrame: 12 months
measure: Global assessment functioning (GAF)
timeFrame: 12 months
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Services in the Capital Region, Denmark
Study officials:
affiliation: Mental Health Services in the Capital Region, Denmark
name: Merete Nordentoft, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Speyer H, Norgaard HC, Hjorthoj C, Madsen TA, Drivsholm S, Pisinger C, Gluud C, Mors O, Krogh J, Nordentoft M. Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity. BMC Psychiatry. 2015 May 23;15:119. doi: 10.1186/s12888-015-0465-2.