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

Study Overview
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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).

Official Title
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Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure at the Thermal Baths of Brides-les-Bains

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Therapeutic education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Témoin<br>No treatment. | |
| Experimental: Action<br>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. | Behavioral: Therapeutic education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the weight. | People weight themselves on a domestic scale. | 0 ; 3 weeks ; 6 months ; 12 months ; 18 months | 
| Quality of life | Assessed with the Short SF-36 questionnaire. | 0 ; 3 weeks ; 6 months ; 12 months | 
| Physical activity | Assessed with the Ricci-Gagnon questionnaire. | 0 ; 3 weeks ; 6 months ; 12 months | 
| Individual's readiness to change | Assessed with the Prochaska questionnaire. | 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. | 0 ; 3 weeks ; 6 months ; 12 months | 
| Felling about the body | Questionnaire on how the participants feel about their body. | 0 ; 3 weeks ; 6 months ; 12 months | 
| Dietary habits | Questionnaire about the dietary habits of the participants. | 0 ; 3 weeks ; 6 months ; 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic education