Clinical trial NCT02284776: Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Therapeutic education
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
Collaborators: name: Association Francaise pour la Recherche Thermale
name: Société des Etablissements Thermaux de Brides-les-Bains et Salins-les-Bains
name: Centre d'Investigation Clinique 9301 INSERM-CHRU de Lille
First posted: 2014-11-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
timeFrame: People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure
Secondary outcomes:
measure: Evolution of the weight.
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months ; 18 months
measure: Quality of life
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months
measure: Physical activity
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months
measure: Individual's readiness to change
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months
measure: Visual and analogical scale for general and psychological well-being and body discomfort.
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months
measure: Felling about the body
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months
measure: Dietary habits
timeFrame: 0 ; 3 weeks ; 6 months ; 12 months
Other outcomes:
Locations:
city: Brides-les-Bains
country: France
facility: SET Brides-les-Bains
state: Savoir
Study officials:
affiliation: Institut Pasteur de Lille
name: Jean-Michel Lecerf, MD
role: PRINCIPAL_INVESTIGATOR
References: