Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2007-03-31
2010-12-31
Brief Summary
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However, the high dropout rate during weight-management strategies presumably means that treatment is mainly effective in highly motivated patients, as the highest success rates are likely to be reported among study completers. Many individuals appear to conclude that the benefits of weight-management strategies are not worth the cost (i.e. time, money, and continued unrewarding efforts). This underlines the critical need to implement new, practical and affordable strategies to induce and maintain weight loss that can be achieved by most patients.
The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the weight (and/or BMI) of overweight or obese patient at 14 months (BMI from 27 to 35).
Detailed Description
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The primary objective of this study was to assess whether a 3- week course of spa therapy is effective to achieve sustained weight loss over a period of 14 months among overweight and obese individuals
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SPA treatment (ST)
Drug : spa treatment during 18 days soon after randomization the most adapted to the concerned pathology and common to all of spa resorts (mineral water drinking, bath with automatic air (bubble bathing), mud body wrapping, manual massages, water exercises) ;
* nutritional counseling (french nutritional recommendations booklet) ;
* caloric restriction and physical training on demand (non mandatory).
SPA treatment (ST)
Drug: spa treatment soon after randomization :
Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts (mineral water drinking, bath with automatic air (bubble bathing), mud body wrapping, manual massages, water exercises ;
* nutritional counseling (french nutritional recommendations booklet) ;
* caloric restriction and physical training on demand (non mandatory).
Non SPA treatment (NST)
Drug: General practitioner (GP) counselling After randomisation Verbal and/or written advice based on the "French national guidelines for a healthy life style" brochure (given to the patient by the GP at baseline)
Non SPA treatment (NST)
Drug: General practitioner (GP) counselling After randomisation Verbal and/or written advice based on the "French national guidelines for a healthy life style" brochure (given to the patient by the GP at baseline)
Interventions
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SPA treatment (ST)
Drug: spa treatment soon after randomization :
Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts (mineral water drinking, bath with automatic air (bubble bathing), mud body wrapping, manual massages, water exercises ;
* nutritional counseling (french nutritional recommendations booklet) ;
* caloric restriction and physical training on demand (non mandatory).
Non SPA treatment (NST)
Drug: General practitioner (GP) counselling After randomisation Verbal and/or written advice based on the "French national guidelines for a healthy life style" brochure (given to the patient by the GP at baseline)
Eligibility Criteria
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Inclusion Criteria
* Voluntary to participate to the study,informed consent form signed after appropriate information
* Affiliation to the social security system or equivalent
Exclusion Criteria
* Pregnancy
* Major eating disorders (compulsive over eating)
* Poor french proficiency
* Involvement in another clinical trial
* Other contra-indications to spa therapy (severe general weakness, inflammatory bowel disease, cirrhosis, severe disability, psychosis and dementia, or Immunodeficiency, cancer in progress).
* Refusal to consent
* Refusal of spa treatment
20 Years
70 Years
ALL
No
Sponsors
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Université Joseph Fourier
OTHER
Université Victor Segalen Bordeaux 2
OTHER
HAT Consultant
UNKNOWN
AXONAL S.A.
UNKNOWN
Association Francaise pour la Recherche Thermale
OTHER
Responsible Party
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Association Francaise pour la Recherche Thermale
Principal Investigators
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Patrick SEROG, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital PARIS
Thierry HANH, MD
Role: STUDY_DIRECTOR
PARIS HAT Consultant
Locations
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Cabinet Médical
Brides-les-Bains, , France
Cabinet Medical
Capvern-les-Bains, , France
Cabinet Medical
Vals-les-Bains, , France
Cabinet Medical
Vichy, , France
Cabinet Medical
Vittel, , France
Countries
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References
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Casez P, Labarere J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, Francois P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.
Mansen A, Tiselius C, Sand P, Fauconnier J, Westerblad H, Rydqvist B, Vennstrom B. Thyroid hormone receptor alpha can control action potential duration in mouse ventricular myocytes through the KCNE1 ion channel subunit. Acta Physiol (Oxf). 2010 Feb;198(2):133-42. doi: 10.1111/j.1748-1716.2009.02052.x. Epub 2009 Oct 14.
Messing B, Man F, Therond P, Hanh T, Thuillier F, Rambaud JC. Selenium status prior to and during one month total parenteral nutrition in gastroenterological patients: A randomised study of two dosages of Se supplementation. Clin Nutr. 1990 Oct;9(5):281-8. doi: 10.1016/0261-5614(90)90037-s.
Peneau S, Thibault H, Meless D, Soulie D, Carbonel P, Roinsol D, Longueville E, Serog P, Deheeger M, Bellisle F, Maurice-Tison S, Rolland-Cachera MF. Anthropometric and behavioral patterns associated with weight maintenance after an obesity treatment in adolescents. J Pediatr. 2008 May;152(5):678-84. doi: 10.1016/j.jpeds.2007.09.053. Epub 2007 Nov 26.
Rolland-Cachera MF, Thibault H, Souberbielle JC, Soulie D, Carbonel P, Deheeger M, Roinsol D, Longueville E, Bellisle F, Serog P. Massive obesity in adolescents: dietary interventions and behaviours associated with weight regain at 2 y follow-up. Int J Obes Relat Metab Disord. 2004 Apr;28(4):514-9. doi: 10.1038/sj.ijo.0802605.
Marcellin P, Cadranel JF, Fontanges T, Poynard T, Pol S, Trepo C, Blin P, Bregman B, Schmidely N, Roudot-Thoraval F, Zarski JP. High rate of adefovir-lamivudine combination therapy in nucleoside-naive patients with chronic hepatitis B in France: results of a national survey in 1730 patients. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1290-6. doi: 10.1097/meg.0b013e32832fba4f.
Fourrier-Reglat A, Lacoin L, Pariente A, Lassalle R, Robinson P, Droz-Perroteau C, Begaud B, Blin P, Moore ND. When patients report diseases that prescribers seem unaware of: discordance between patient and physician reporting of risk-related previous history in NSAID users from the CADEUS study. Clin Pharmacol Ther. 2010 Nov;88(5):668-75. doi: 10.1038/clpt.2010.166. Epub 2010 Sep 22.
Blin P, Blazejewski S, Lignot S, Lassalle R, Bernard MA, Jayles D, Theophile H, Benichou J, Demeaux JL, Ebbo D, Franck J, Moride Y, Peyramond D, Rouveix B, Sturkenboom M, Gehanno P, Droz C, Moore N. Effectiveness of antibiotics for acute sinusitis in real-life medical practice. Br J Clin Pharmacol. 2010 Sep;70(3):418-28. doi: 10.1111/j.1365-2125.2010.03710.x.
Saraux A, Combe B, Blin P, Bregman B, Chartier M, Durieux-Mehlman S, Guillemin F. Survey of the therapeutic management of rheumatoid arthritis in France: the OPALE study. Clin Exp Rheumatol. 2010 May-Jun;28(3):325-32. Epub 2010 Jun 23.
Fourrier-Reglat A, Cuong HM, Lassalle R, Depont F, Robinson P, Droz-Perroteau C, Pariente A, Begaud B, Blin P, Moore N. Concordance between prescriber- and patient-reported previous medical history and NSAID indication in the CADEUS cohort. Pharmacoepidemiol Drug Saf. 2010 May;19(5):474-81. doi: 10.1002/pds.1951.
Colver AF, Dickinson HO; SPARCLE group. Study protocol: determinants of participation and quality of life of adolescents with cerebral palsy: a longitudinal study (SPARCLE2). BMC Public Health. 2010 May 26;10:280. doi: 10.1186/1471-2458-10-280.
Colver AF, Dickinson HO, Parkinson K, Arnaud C, Beckung E, Fauconnier J, Marcelli M, McManus V, Michelsen SI, Parkes J, Thyen U. Access of children with cerebral palsy to the physical, social and attitudinal environment they need: a cross-sectional European study. Disabil Rehabil. 2011;33(1):28-35. doi: 10.3109/09638288.2010.485669. Epub 2010 May 6.
Fauconnier J, Pasquie JL, Bideaux P, Lacampagne A, Richard S. Cardiomyocytes hypertrophic status after myocardial infarction determines distinct types of arrhythmia: role of the ryanodine receptor. Prog Biophys Mol Biol. 2010 Sep;103(1):71-80. doi: 10.1016/j.pbiomolbio.2010.01.002. Epub 2010 Jan 28.
Fauconnier J, Thireau J, Reiken S, Cassan C, Richard S, Matecki S, Marks AR, Lacampagne A. Leaky RyR2 trigger ventricular arrhythmias in Duchenne muscular dystrophy. Proc Natl Acad Sci U S A. 2010 Jan 26;107(4):1559-64. doi: 10.1073/pnas.0908540107. Epub 2010 Jan 4.
Other Identifiers
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MAATHERMES
Identifier Type: -
Identifier Source: org_study_id