Early and Short Psycho-educational Lifestyle Intervention

Schizophrenia Clinical Trial

— HYVIE  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02657941
• Other study ID #: 2015-A00142-47
• Status: Terminated
• Phase: N/A
• First received: January 13, 2016
• Last updated: February 7, 2018
• Start date: December 9, 2015
• Est. completion date: November 14, 2017

Study information

• Verified date: February 2018
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

This both psychoeducational programs have a common objective through different methods to promote early awareness of the lifestyle (physical activity and dietary balance) of hospitalized adult patients who receive a psychotropic medication that may cause increased morbidity cardiovascular mortality through excessive weight gain and development of metabolic syndrome.

Both programs have the same number of sessions of the same duration (three weekly sessions of one hour); the same themes are addressed (risk of weight gain and cardiovascular risks induced by treatments, benefits of physical activity and of a balanced diet); only the psycho-educational methods differ.

These programs are for patients with serious mental illness (mainly psychotic disorders and mood disorders), hospitalized in one of the four adult psychiatric units of the Eastern Sector of the Vinatier Hospital in Bron, France. Patients are treatment-naive or already under psychotropic drug(s) but a new antipsychotic or mood-stabilizer must have been started during this hospitalization.

Patients are included on indication of their referring physician in hospital, as soon as their clinical status is compatible. They are randomized to one of two therapeutic educational groups. The two parallel modules of psycho-education are co-managed by two nurses specialized in psycho-education. The study is based on a module per month for 18 months. Patients included will receive three individual interviews with a nurse or psychiatrist: the first interview before module, the second after module and the third three months after module.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Motivational group
Three weekly sessions of one hour, co-managed by two nurses specialized in psycho-education Session 1: General information on the risk of weight gain and the means of prevention, motivational balance on the practice of physical activity, developing a personal goal, information about the sports center Session 2: brainstorming and card game on Food Hygiene Session 3: Find situations at risk of snacking and consider alternative lines
• educational group
Three weekly sessions of one hour, co-managed by two nurses specialized in psycho-education Session 1: General information on the risk of weight gain and means of prevention, video on physical activity, discussions with therapists, information about the sports center Session 2: Video on Food Hygiene, discussions with therapists Session 3: Return on basic concepts covered in the first 2 sessions

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

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