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

Obesity Clinical Trial

— Educatherm  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02284776
• Other study ID #: 2013-A00226-43
• Status: Active, not recruiting
• Phase: N/A
• First received: October 30, 2013
• Last updated: December 15, 2015
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	SET Brides-les-Bains	Brides-les-Bains	Savoir

Sponsors (4)

Lead Sponsor	Collaborator
Institut Pasteur de Lille	Association Francaise pour la Recherche Thermale, Centre d'Investigation Clinique 9301 INSERM-CHRU de Lille, Société des Etablissements Thermaux de Brides-les-Bains et Salins-les-Bains

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evolution of the weight.	People weight themselves on a domestic scale.	0 ; 3 weeks ; 6 months ; 12 months ; 18 months	No
Secondary	Quality of life	Assessed with the Short SF-36 questionnaire.	0 ; 3 weeks ; 6 months ; 12 months	No
Secondary	Physical activity	Assessed with the Ricci-Gagnon questionnaire.	0 ; 3 weeks ; 6 months ; 12 months	No
Secondary	Individual's readiness to change	Assessed with the Prochaska questionnaire.	0 ; 3 weeks ; 6 months ; 12 months	No
Secondary	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	No
Secondary	Felling about the body	Questionnaire on how the participants feel about their body.	0 ; 3 weeks ; 6 months ; 12 months	No
Secondary	Dietary habits	Questionnaire about the dietary habits of the participants.	0 ; 3 weeks ; 6 months ; 12 months	No