Maâthermes: Spa Treatment for Overweight and Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 3

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).
    

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 An unpublished pilot study conducted in 2004, in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
    

Intervention name(s): SPA treatment (ST); Non SPA treatment (NST)
Intervention type(s): Other; Other
Intervention description(s): 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).; 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Balneotherapy; Spa Therapy; balneology; hydrotherapy; SF 12; Nutritional counselling; Zelen double consent; Lifestyle modification program; IMC