Early and Short Psycho-educational Lifestyle Intervention

NCT02657941 | Terminated DMC

• 1 other identifier: 2015-A00142-47
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Keywords

Schizophrenia; Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  Change from baseline after 3 months

Secondary Outcomes (7)

• Changes in waist circumference (cm)

  Change from baseline after 3 months

• 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

• 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

• 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

• Increased motivation to participate in a non-hospital treatment group on food and cooking

  Change from baseline after 3 months

Study Arms (2)

Motivational group

EXPERIMENTAL

psycho-education program inspired by motivational interviewing and behavioral psychotherapy

Behavioral: Motivational group

educational group

ACTIVE COMPARATOR

exclusively informative psycho-education program

Behavioral: educational group

Interventions

Motivational group BEHAVIORAL

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

Motivational group

educational group BEHAVIORAL

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

educational group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• minor
• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Schizophrenia; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• MAGES NICOLAS, PH

  Responsable de service G08 - Villeurbanne et de l'Unité Polaire de Psychoéducation, Pôle Est, Centre Hospitalier Le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 18, 2016
• Study Start: December 9, 2015
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)