CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 400 enrolled
Drug / intervention
SPA treatment (ST) +1 moreother
Likely dose
Not stated in record
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Search/NCT01258114
NCT01258114Phase 3Completed

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

Association Francaise pour la Recherche Thermale·interventional·Posted Dec 10, 2010·Updated Dec 10, 2010

In Brief

A Phase 3 clinical trial evaluating SPA treatment (ST) and Non SPA treatment (NST) for Overweight and Obesity. Completed, enrolled 400 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesFrance

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2010
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.6 years ago

Interventions

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)