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Maâthermes: Spa Treatment for Overweight and Obesity (MAATHERMES)

This study has been completed.
Sponsor:
Collaborators:
Université Joseph Fourier
Université Victor Segalen Bordeaux 2
HAT Consultant
AXONAL S.A.
Information provided by:
Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:
NCT01258114
First received: December 8, 2010
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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).


Condition Intervention Phase
Overweight
Obesity
Other: SPA treatment (ST)
Other: Non SPA treatment (NST)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Maâthermes a Randomised Controlled Trial of Spa Treatment of Overweight and Obesity

Resource links provided by NLM:


Further study details as provided by Association Francaise pour la Recherche Thermale:

Primary Outcome Measures:
  • 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 [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    spa treatment during 18 days soon after randomization Weight loss assessed in kg and kg/m2 at 14 months


Secondary Outcome Measures:
  • Patients achieving a weight loss of 5% [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Quality of life : assessed by SF12 [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
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).
Other Name: SPA treatment (ST)
Sham Comparator: 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)
Other: 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)
Other Name: Non SPA treatment (NST)

Detailed 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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258114

Locations
France
Cabinet Médical
Brides les bains, France, 73000
Cabinet Medical
Capvern les bains, France, 65000
Cabinet Medical
Vals les bains, France, 07000
Cabinet Medical
Vichy, France, 03000
Cabinet Medical
Vittel, France, 88000
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Université Joseph Fourier
Université Victor Segalen Bordeaux 2
HAT Consultant
AXONAL S.A.
Investigators
Principal Investigator: Patrick SEROG, MD Hospital PARIS
Study Director: Thierry HANH, MD PARIS HAT Consultant
  More Information

Publications:
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. Marcellin P, Cadranel JF, Fontanges T, Poynard T, Pol S, Trepo C, Blin P, Bregman B, Schmidely N, Roudot-Thoraval F, Zarski JP. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1290-6
Effectiveness of antibiotics for acute sinusitis in real-life medical practice. 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. Br J Clin Pharmacol. 2010 Sep;70(3):418-28
Survey of the therapeutic management of rheumatoid arthritis in France: the OPALE study. Saraux A, Combe B, Blin P, Bregman B, Chartier M, Durieux-Mehlman S, Guillemin F. Clin Exp Rheumatol. 2010 May-Jun;28(3):325-32. Epub 2010 Jun 23
Study protocol: determinants of participation and quality of life of adolescents with cerebral palsy: a longitudinal study (SPARCLE2). Colver AF, Dickinson HO; SPARCLE group. BMC Public Health. 2010 May 26;10:280

Responsible Party: Docteur Renée-Claire MANCRET, Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT01258114     History of Changes
Other Study ID Numbers: MAATHERMES
Study First Received: December 8, 2010
Last Updated: December 9, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by Association Francaise pour la Recherche Thermale:
Overweight
Obesity
Balneotherapy
Spa Therapy
balneology
hydrotherapy
SF 12
Nutritional counselling
Zelen double consent
Lifestyle modification program
IMC

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014