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NCT Number: NCT01258114

Maâthermes: Spa Treatment for 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).

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cabinet Médical, Brides-les-Bains, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPA treatment (ST)

Other

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)

Other

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Patients achieving a weight loss of 5%

    Time frame: 14 months

  2. Quality of life : assessed by SF12

    Time frame: 14 months

Sponsors and collaborators

Lead sponsor

Association Francaise pour la Recherche Thermale

Other

Collaborators

  • AXONAL S.A.
  • HAT Consultant
  • Université Joseph Fourier
  • Université Victor Segalen Bordeaux 2

Registry information

Official study title

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

Acronym: MAATHERMES

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2010
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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