Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure

NCT ID: NCT02284776

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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

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Obesity

Keywords

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Therapeutic education

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Témoin

No treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Action

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.

Group Type EXPERIMENTAL

Therapeutic education

Intervention Type BEHAVIORAL

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.

Interventions

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Therapeutic education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role collaborator

Société des Etablissements Thermaux de Brides-les-Bains et Salins-les-Bains

UNKNOWN

Sponsor Role collaborator

Centre d'Investigation Clinique 9301 INSERM-CHRU de Lille

UNKNOWN

Sponsor Role collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel Lecerf

medical doctor specializing in endocrinology and metabolic diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Michel Lecerf, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

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SET Brides-les-Bains

Brides-les-Bains, Savoir, France

Site Status

Countries

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France

Other Identifiers

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2013-A00226-43

Identifier Type: -

Identifier Source: org_study_id