Maâthermes: Spa Treatment for Overweight and Obesity (MAATHERMES)

December 9, 2010 updated by: Association Francaise pour la Recherche Thermale

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 An unpublished pilot study conducted in 2004, in several French spa resorts, showed that an additional 25% decrease in BMI was obtained for overweight and obese individuals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

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Cabinet Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
spa treatment during 18 days soon after randomization Weight loss assessed in kg and kg/m2 at 14 months
14 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients achieving a weight loss of 5%
Time Frame: 14 months
14 months
Quality of life : assessed by SF12
Time Frame: 14 months
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Francaise pour la Recherche Thermale

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAATHERMES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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