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Clinical Trials/NCT02284776
NCT02284776
Unknown
N/A

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

Institut Pasteur de Lille1 site in 1 country400 target enrollmentJuly 2013
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Institut Pasteur de Lille
Enrollment
400
Locations
1
Primary Endpoint
Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
April 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Michel Lecerf

medical doctor specializing in endocrinology and metabolic diseases

Institut Pasteur de Lille

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

Outcomes

Primary Outcomes

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

People weight themselves on a domestic scale.

Secondary Outcomes

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

Study Sites (1)

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