Maâthermes: Spa Treatment for Overweight and Obesity

Obesity Clinical Trial

— MAATHERMES  

Official title:

Maâthermes a Randomised Controlled Trial of Spa Treatment of Overweight and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258114
• Other study ID #: MAATHERMES
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2010
• Last updated: December 9, 2010
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

Public health campaigns and industry-supported changes in our food supply have obviously failed to control the epidemic to date. However, customized life style modification programs (LSMP) comprising diet, physical activity and behavioral therapy (a set of principles designed to help patients achieve their goals) induce weight loss of 10% of baseline body weight after 16 to 26 weeks of intervention . Long-term weight control is then facilitated by an appropriate weight-loss maintenance strategy such as continued patient-therapist contact (whether provided in person or by telephone or e-mail). This strategy allows patients to stabilize at an average of 5% and 3% loss of baseline body weight after 1 and 2 years, respectively. Numerous reports have concluded that this modest weight loss contributes to important health benefits.

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).

Description:

Spa therapy, or mineral spring water therapy, is a 3-week LSMP that has been shown to be sufficiently effective to control overweight and obesity to be approved and subsidized by French national health insurance. However, good quality scientific evidence is still required to support the benefit of spa therapy. An unpublished pilot study conducted in 2004, in several French spa resorts, showed that an additional 25% decrease in BMI was obtained for overweight and obese individuals enrolled in spa therapy as compared to individuals receiving classic weight management (-1.4 kg/m² and -1.05 kg/m2 respectively). However, no scientific conclusions can be drawn in the absence of relevant methodological and clinical information. This multicenter, controlled trial was designed to obtain sufficient statistical power to assess the benefits of spa therapy based on an evidence- based medicine approach.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Both sexes, more than 20 years and less than 70 years old patients with overweight (BMI>27) or obesity (BMI<35). Available for a spa treatment during 18 days, and a follow-up period of 14 months

• Voluntary to participate to the study,informed consent form signed after appropriate information

• Affiliation to the social security system or equivalent

Exclusion Criteria:

• Previous spa therapy for weight problems

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	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

Sponsors (5)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale	AXONAL S.A., HAT Consultant, Université Joseph Fourier, Université Victor Segalen Bordeaux 2

Country where clinical trial is conducted

France, 

References & Publications (14)

Blin P, Blazejewski S, Lignot S, Lassalle R, Bernard MA, Jayles D, Théophile H, Bénichou 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. — View Citation

Casez P, Labarère J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, François 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. — View Citation

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. — View Citation

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. — View Citation

Fauconnier J, Pasquié 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. Review. — View Citation

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. — View Citation

Fourrier-Réglat A, Cuong HM, Lassalle R, Depont F, Robinson P, Droz-Perroteau C, Pariente A, Bégaud 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. — View Citation

Fourrier-Réglat A, Lacoin L, Pariente A, Lassalle R, Robinson P, Droz-Perroteau C, Bégaud 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. — View Citation

Mansén A, Tiselius C, Sand P, Fauconnier J, Westerblad H, Rydqvist B, Vennström 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. — View Citation

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-naïve 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. — View Citation

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. — View Citation

Péneau S, Thibault H, Meless D, Soulié D, Carbonel P, Roinsol D, Longueville E, Sérog 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. — View Citation

Rolland-Cachera MF, Thibault H, Souberbielle JC, Soulié 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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPA treatment (ST) : Active comparator spa treatment during 18 days soon after randomization. The Weight loss will be measured in kg and kg/m2 at 14 months	spa treatment during 18 days soon after randomization Weight loss assessed in kg and kg/m2 at 14 months	14 months	No
Secondary	Patients achieving a weight loss of 5%		14 months	No
Secondary	Quality of life : assessed by SF12		14 months	No