NCT02284776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
1 year until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

October 30, 2013

Last Update Submit

December 15, 2015

Conditions

Obesity

Keywords

Therapeutic education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Témoin

NO INTERVENTION

No treatment.

Action

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.

Behavioral: Therapeutic education

Interventions

Therapeutic educationBEHAVIORAL

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.

Action

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SET Brides-les-Bains

Brides-les-Bains, Savoir, 73570, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Michel Lecerf, MD

    Institut Pasteur de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor specializing in endocrinology and metabolic diseases

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2014

Study Start

July 1, 2013

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

FR(1)