ObesityEducathermNCT02284776
Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure
A study testing Therapeutic education in people with Obesity, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients. The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Apr 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) over 27 kg/m² (or equal)
- Has a valid email address, has access to the internet and to a telephone line
- Has a domestic scale compatible with its weight
- Signed the consent form
- Susceptible to accept the obligations generated by the study
- Has a health insurance
Who cannot join
- Has a progressive illness at the time of the study (cancer, neurodegenerative disease...)
- Is pregnant
- Follows the hydro-therapeutic cure in order to cure rheumatism
- Trying to lose weight prior to a surgery
- Has a diagnosed eating disorder
- Has no physical activity due to a handicap or a serious osteoarthritis
Show all 11Show fewer
- Has taken a weight-loss drug (Orlistat) in the past month or will likely do so in the future
- Is taking a Desmopressin-based drug
- Is unable to understand or follow the protocol
- Is deprived of liberty
- Is under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure at the Thermal Baths of Brides-les-Bains
The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients.
The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group.
Read the detailed description
The participants are people that come to the thermal baths in order to follow an hydrotherapeutic cure (of about 3 weeks). For the Action group, they also follow a course of therapeutic education where they are given advices on how they should eat and have a regular physical activity.
This therapeutic education in addition of the hydrotherapeutic cure should help them lose weight and not gain in again.
The participants are followed for 18 months (17 months after leaving the thermal baths).
- Conditions
- Obesity
- Being tested
- Therapeutic education
- Keywords
- Therapeutic education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationBehavioural
People in hydrotherapeutic cure are following a program of Therapeutic Education. This program includes dietary advice, physical activities, behavior advice in order to change the lifestyle of the obese people.
| Study group | Role | What they receive |
|---|---|---|
| Témoin | No intervention | No treatment. |
| Action | Experimental | People in hydrotherapeutic cure are following a program of Therapeutic Education. This program includes dietary advice, physical activities, behavior advice in order to change the lifestyle of the obese people. Receives: Behavioral: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
People weight themselves on a domestic scale.
Measured: People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure
Secondary outcomes (7)
Evolution of the weight.
People weight themselves on a domestic scale.
Measured: 0 ; 3 weeks ; 6 months ; 12 months ; 18 months
Quality of life
Assessed with the Short SF-36 questionnaire.
Measured: 0 ; 3 weeks ; 6 months ; 12 months
Physical activity
Assessed with the Ricci-Gagnon questionnaire.
Measured: 0 ; 3 weeks ; 6 months ; 12 months
Individual's readiness to change
Assessed with the Prochaska questionnaire.
Measured: 0 ; 3 weeks ; 6 months ; 12 months
Visual and analogical scale for general and psychological well-being and body discomfort.
Participants mark down on a 10cm scale how they feel.
Measured: 0 ; 3 weeks ; 6 months ; 12 months
Felling about the body
Questionnaire on how the participants feel about their body.
Measured: 0 ; 3 weeks ; 6 months ; 12 months
Dietary habits
Questionnaire about the dietary habits of the participants.
Measured: 0 ; 3 weeks ; 6 months ; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale, Société des Etablissements Thermaux de Brides-les-Bains et Salins-les-Bains, Centre d'Investigation Clinique 9301 INSERM-CHRU de Lille
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284776
- Sponsor's protocol ID
- 2013-A00226-43
- Acronym
- Educatherm
- Status last verified
- Dec 2015
- First submitted
- 30 Oct 2013
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure at the Thermal Baths of Brides-les-Bains
- ClinicalTrials.gov ID
- NCT02284776
- Acronym / sponsor ID
- Educatherm / 2013-A00226-43
- Conditions
- Obesity
- Keywords
- Therapeutic education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale, Société des Etablissements Thermaux de Brides-les-Bains et Salins-les-Bains, Centre d'Investigation Clinique 9301 INSERM-CHRU de Lille
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 6 Nov 2014 (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.
The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients.
The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group.
Detailed description
The participants are people that come to the thermal baths in order to follow an hydrotherapeutic cure (of about 3 weeks). For the Action group, they also follow a course of therapeutic education where they are given advices on how they should eat and have a regular physical activity.
This therapeutic education in addition of the hydrotherapeutic cure should help them lose weight and not gain in again.
The participants are followed for 18 months (17 months after leaving the thermal baths).
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Témoin | No intervention | –No treatment. |
| Action | Experimental | Behavioral: Therapeutic educationPeople in hydrotherapeutic cure are following a program of Therapeutic Education. This program includes dietary advice, physical activities, behavior advice in order to change the lifestyle of the obese people. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body Mass Index (BMI) over 27 kg/m² (or equal)
- Has a valid email address, has access to the internet and to a telephone line
- Has a domestic scale compatible with its weight
- Signed the consent form
- Susceptible to accept the obligations generated by the study
Key exclusion criteria (11 listed)
- Has a progressive illness at the time of the study (cancer, neurodegenerative disease...)
- Is pregnant
- Follows the hydro-therapeutic cure in order to cure rheumatism
- Trying to lose weight prior to a surgery
- Has a diagnosed 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 |
|---|---|---|
| Therapeutic educationPeople in hydrotherapeutic cure are following a program of Therapeutic Education. This program includes dietary advice, physical activities, behavior advice in order to change the lifestyle of the obese people. | Behavioural | Action |
Primary outcome
Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
Time frame: People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure
People weight themselves on a domestic scale.
7 secondary outcomes
Evolution of the weight.
Time frame: 0 ; 3 weeks ; 6 months ; 12 months ; 18 months
Quality of life
Time frame: 0 ; 3 weeks ; 6 months ; 12 months
Physical activity
Time frame: 0 ; 3 weeks ; 6 months ; 12 months
Individual's readiness to change
Time frame: 0 ; 3 weeks ; 6 months ; 12 months
Visual and analogical scale for general and psychological well-being and body discomfort.
Time frame: 0 ; 3 weeks ; 6 months ; 12 months
Felling about the body
Time frame: 0 ; 3 weeks ; 6 months ; 12 months
Dietary habits
Time frame: 0 ; 3 weeks ; 6 months ; 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education in people with Obesity, run by Institut Pasteur de Lille 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Dec 2015. 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?
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 the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure (time frame: People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure). 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 16 Dec 2015.