Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early and Short Psycho-educational Lifestyle Intervention (HYVIE)

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.
ClinicalTrials.gov Identifier: NCT02657941
Recruitment Status : Terminated (inclusion problem)
First Posted : January 18, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief 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).


Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Motivational group Behavioral: educational group Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Motivational group
psycho-education program inspired by motivational interviewing and behavioral psychotherapy
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


Active Comparator: educational group
exclusively informative psycho-education program
Behavioral: 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





Primary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: Change from baseline after 3 months ]

Secondary Outcome Measures :
  1. Changes in waist circumference (cm) [ Time Frame: Change from baseline after 3 months ]
    waist circumference measurement during individual interviews standardized assessment (medical or nursing)

  2. 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) [ Time Frame: Change from baseline after 3 months ]
  3. 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) [ Time Frame: Change from baseline after 3 months ]
  4. Appearance of a fasting blood glucose higher than pathological threshold defined by ANAES in 1999 (> 1.26 g/l on two samples) [ Time Frame: Change from baseline after 3 months ]
  5. Increased motivation to participate in a non-hospital treatment group on food and cooking [ Time Frame: Change from baseline after 3 months ]
    subjective criterion (declarative) rated on a visual scale in individual interviews standardized assessment (medical or nursing)

  6. Increased motivation to participate in a non-hospital treatment group on physical activity or sport [ Time Frame: Change from baseline after 3 months ]
    subjective criterion (declarative) rated on a visual scale in individual interviews standardized assessment (medical or nursing)

  7. Improved knowledge of balance and food hygiene [ Time Frame: Change from baseline after 3 months ]
    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)



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 to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02657941


Locations
Layout table for location information
France
Centre Hospitalier Le Vinatier
Bron Cedex, France, 69678
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Layout table for investigator information
Principal Investigator: MAGES NICOLAS, PH Responsable de service G08 - Villeurbanne et de l'Unité Polaire de Psychoéducation, Pôle Est, Centre Hospitalier Le Vinatier

Layout table for additonal information
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02657941     History of Changes
Other Study ID Numbers: 2015-A00142-47
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hôpital le Vinatier:
Schizophrenia
Obesity
Metabolic Syndrome

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders