SchizophreniaHYVIENCT02657941
Early and Short Psycho-educational Lifestyle Intervention
A study testing Motivational group and educational group in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Motivational group and educational group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2015to 14 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Motivational group, educational group
- Keywords
- Schizophrenia, Obesity, Metabolic Syndrome
- Medical subject headings
- Schizophrenia, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational groupBehavioural
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 groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Motivational group | Experimental | psycho-education program inspired by motivational interviewing and behavioral psychotherapy Receives: Behavioral: Motivational group |
| educational group | Active comparator | exclusively informative psycho-education program Receives: Behavioral: educational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg)
Measured: Change from baseline after 3 months
Secondary outcomes (7)
Changes in waist circumference (cm)
waist circumference measurement during individual interviews standardized assessment (medical or nursing)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline after 3 months
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)
Measured: Change from baseline after 3 months
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)
Measured: Change from baseline after 3 months
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)
Measured: Change from baseline after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start9 Dec 2015
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Why it stopped: inclusion problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAGES NICOLAS, PH, Principal investigator, Responsable de service G08 - Villeurbanne et de l'Unité Polaire de Psychoéducation, Pôle Est, Centre Hospitalier Le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657941
- Sponsor's protocol ID
- 2015-A00142-47
- Acronym
- HYVIE
- Status last verified
- Feb 2018
- First submitted
- 13 Jan 2016
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02657941
- Acronym / sponsor ID
- HYVIE / 2015-A00142-47
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Obesity, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion problem
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational group | Experimental | Behavioral: Motivational grouppsycho-education program inspired by motivational interviewing and behavioral psychotherapy |
| educational group | Active comparator | Behavioral: educational groupexclusively informative psycho-education program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- minor
- aged over 45 years at inclusion
- pregnancy or breastfeeding
- patient suffering from a neurodegenerative disease
- patient suffering from an eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational groupThree 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 | Behavioural | Motivational group |
| educational groupThree 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 | Behavioural | educational group |
Primary outcome
Change in body weight (kg)
Time frame: Change from baseline after 3 months
7 secondary outcomes
Changes in waist circumference (cm)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline after 3 months
Increased motivation to participate in a non-hospital treatment group on food and cooking
Time frame: Change from baseline after 3 months
Increased motivation to participate in a non-hospital treatment group on physical activity or sport
Time frame: Change from baseline after 3 months
Improved knowledge of balance and food hygiene
Time frame: Change from baseline after 3 months
Results and safety
The study was stopped early (reason given: inclusion problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAGES NICOLAS, PH principal investigator
Responsable de service G08 - Villeurbanne et de l'Unité Polaire de Psychoéducation, Pôle Est, Centre Hospitalier Le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational group and educational group in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) (time frame: Change from baseline after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.