Schizophrenia Clinical Trial
— HYVIEOfficial title:
Early and Short Psycho-educational Lifestyle Intervention to Prevent Weight Gain Induced by Psychotropic Drugs in Adults With Severe Mental Illness: a Randomized Controlled Trial
Verified date | February 2018 |
Source | Hôpital le Vinatier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
People with severe mental illness have an increased risk of somatic comorbidities such as
metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce
an increased risk of early mortality, mainly because of cardiovascular diseases.
These high cardio-metabolic risks result of several factors such as lack of access to medical
care, a poor and unbalanced nutrition, physical inactivity and smoking but they are also
exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed to
treat their psychiatric disorder.
These prevention and awareness interventions in lifestyle are most often implemented in
ambulatory stabilized patients. Also weight gain occurs in the early months of treatment. The
therapeutic education program evaluated in this study seeks to potentiate the effectiveness
of these preventive measures through early awareness in hospitalized patients.
Finally, this study aims to compare the efficacy of two early and short programs on health
behavior: first a program inspired by motivational interviewing and behavioral psychotherapy
and secondly an exclusively educational program (information, formative assessment).
Status | Terminated |
Enrollment | 10 |
Est. completion date | November 14, 2017 |
Est. primary completion date | November 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Hospitalized patients in one of four adult psychiatric units of eastern pole of the Hospital Vinatier - man or woman - aged between 18 (major) and 45 years (age limit on inducing a cardiovascular risk) - receiving anti-psychotic medication or antiepileptic mood stabilizer introduced during this hospitalization: patients must be treatment-naive or already under psychotropic drug(s) since less than 10 years Exclusion Criteria: - minor - aged over 45 years at inclusion - pregnancy or breastfeeding - patient suffering from a neurodegenerative disease - patient suffering from an eating disorder - patient with a BMI> 30 - patient treated for more than 10 years by anti-psychotic medication or antiepileptic mood stabilizer |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Le Vinatier | Bron Cedex |
Lead Sponsor | Collaborator |
---|---|
Hôpital le Vinatier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in body weight (kg) | Change from baseline after 3 months | ||
Secondary | Changes in waist circumference (cm) | waist circumference measurement during individual interviews standardized assessment (medical or nursing) | Change from baseline after 3 months | |
Secondary | Appearance of a SBP (systolic blood pressure) greater than the pathological threshold (> 140 mmHg) or DBP (diastolic blood pressure) above the pathological level (> 90 mmHg) | Change from baseline after 3 months | ||
Secondary | Appearance of HDL cholesterol below the pathological threshold (<0.40 g/l) and / or LDL cholesterol greater than the pathological threshold (> 2.20 g/l) and / or higher triglyceride pathological level (> 1.5 g/l) | Change from baseline after 3 months | ||
Secondary | Appearance of a fasting blood glucose higher than pathological threshold defined by ANAES in 1999 (> 1.26 g/l on two samples) | Change from baseline after 3 months | ||
Secondary | Increased motivation to participate in a non-hospital treatment group on food and cooking | subjective criterion (declarative) rated on a visual scale in individual interviews standardized assessment (medical or nursing) | Change from baseline after 3 months | |
Secondary | Increased motivation to participate in a non-hospital treatment group on physical activity or sport | subjective criterion (declarative) rated on a visual scale in individual interviews standardized assessment (medical or nursing) | Change from baseline after 3 months | |
Secondary | Improved knowledge of balance and food hygiene | increase of at least 3 points out of 19 in the note obtained during the evaluation done in individual interviews standardized assessment (medical or nursing) | Change from baseline after 3 months |
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