Overview

This trial is active, not recruiting.

Condition obesity
Treatment therapeutic education
Sponsor Institut Pasteur de Lille
Collaborator Association Francaise pour la Recherche Thermale
Start date July 2013
End date February 2016
Trial size 400 participants
Trial identifier NCT02284776, 2013-A00226-43

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Arm
(No Intervention)
No treatment.
(Experimental)
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.
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.

Primary Outcomes

Measure
Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
time frame: People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure

Secondary Outcomes

Measure
Evolution of the weight.
time frame: 0 ; 3 weeks ; 6 months ; 12 months ; 18 months
Quality of life
time frame: 0 ; 3 weeks ; 6 months ; 12 months
Physical activity
time frame: 0 ; 3 weeks ; 6 months ; 12 months
Individual's readiness to change
time frame: 0 ; 3 weeks ; 6 months ; 12 months
Visual and analogical scale for general and psychological well-being and body discomfort.
time frame: 0 ; 3 weeks ; 6 months ; 12 months
Felling about the body
time frame: 0 ; 3 weeks ; 6 months ; 12 months
Dietary habits
time frame: 0 ; 3 weeks ; 6 months ; 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jean-Michel Lecerf, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Institut Pasteur de Lille.