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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Therapeutic education

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Savoir
    • Brides-les-Bains, Savoir, France, 73570
      • SET Brides-les-Bains

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Témoin; No treatment.
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• 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
• Investigators: Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Therapeutic education
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2013-A00226-43