OverweightPhase 3MAATHERMESNCT01258114
Maâthermes: Spa Treatment for Overweight and Obesity
A Phase 3 study testing SPA treatment (ST) and Non SPA treatment (NST) in people with Overweight and Obesity, run by Association Francaise pour la Recherche Thermale at 5 sites in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- SPA treatment (ST) and Non SPA treatment (NST)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2007to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cabinet Médical
Brides-les-Bains, 73000
Cabinet Medical
Capvern-les-Bains, 65000
Cabinet Medical
Vals-les-Bains, 07000
Cabinet Medical
Vichy, 03000
Cabinet Medical
Vittel, 88000
About this study
Official title: 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).
Read the 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
- Conditions
- Overweight, Obesity
- Being tested
- SPA treatment (ST), Non SPA treatment (NST)
- Keywords
- Overweight, Obesity, Balneotherapy, Spa Therapy, balneology, hydrotherapy, SF 12, Nutritional counselling, Zelen double consent, Lifestyle modification program, IMC
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| SPA treatment (ST) | Active comparator | 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). Receives: Other: SPA treatment (ST) |
| Non SPA treatment (NST) | Sham comparator | 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) Receives: Other: Non SPA treatment (NST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
spa treatment during 18 days soon after randomization Weight loss assessed in kg and kg/m2 at 14 months
Measured: 14 months
Secondary outcomes (2)
Patients achieving a weight loss of 5%
Measured: 14 months
Quality of life : assessed by SF12
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startMar 2007
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- Université Joseph Fourier, Université Victor Segalen Bordeaux 2, HAT Consultant, AXONAL S.A.
- Investigators
- Patrick SEROG, MD, Principal investigator, Hospital PARISThierry HANH, MD, Study director, PARIS HAT Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258114
- Sponsor's protocol ID
- MAATHERMES
- Acronym
- MAATHERMES
- Status last verified
- Dec 2010
- First submitted
- 8 Dec 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Peneau S, Thibault H, Meless D, Soulie D, Carbonel P, Roinsol D, Longueville E, Serog P, Deheeger M, Bellisle F, Maurice-Tison S, Rolland-Cachera MF. Anthropometric and behavioral patterns associated with weight maintenance after an obesity treatment in adolescents. J Pediatr. 2008 May;152(5):678-84. doi: 10.1016/j.jpeds.2007.09.053. Epub 2007 Nov 26.
PubMed 18410773Rolland-Cachera MF, Thibault H, Souberbielle JC, Soulie D, Carbonel P, Deheeger M, Roinsol D, Longueville E, Bellisle F, Serog P. Massive obesity in adolescents: dietary interventions and behaviours associated with weight regain at 2 y follow-up. Int J Obes Relat Metab Disord. 2004 Apr;28(4):514-9. doi: 10.1038/sj.ijo.0802605.
PubMed 14968129Marcellin P, Cadranel JF, Fontanges T, Poynard T, Pol S, Trepo C, Blin P, Bregman B, Schmidely N, Roudot-Thoraval F, Zarski JP. High rate of adefovir-lamivudine combination therapy in nucleoside-naive patients with chronic hepatitis B in France: results of a national survey in 1730 patients. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1290-6. doi: 10.1097/meg.0b013e32832fba4f.
PubMed 20964259Fourrier-Reglat A, Lacoin L, Pariente A, Lassalle R, Robinson P, Droz-Perroteau C, Begaud B, Blin P, Moore ND. When patients report diseases that prescribers seem unaware of: discordance between patient and physician reporting of risk-related previous history in NSAID users from the CADEUS study. Clin Pharmacol Ther. 2010 Nov;88(5):668-75. doi: 10.1038/clpt.2010.166. Epub 2010 Sep 22.
PubMed 20861835Blin P, Blazejewski S, Lignot S, Lassalle R, Bernard MA, Jayles D, Theophile H, Benichou J, Demeaux JL, Ebbo D, Franck J, Moride Y, Peyramond D, Rouveix B, Sturkenboom M, Gehanno P, Droz C, Moore N. Effectiveness of antibiotics for acute sinusitis in real-life medical practice. Br J Clin Pharmacol. 2010 Sep;70(3):418-28. doi: 10.1111/j.1365-2125.2010.03710.x.
PubMed 20716243Saraux A, Combe B, Blin P, Bregman B, Chartier M, Durieux-Mehlman S, Guillemin F. Survey of the therapeutic management of rheumatoid arthritis in France: the OPALE study. Clin Exp Rheumatol. 2010 May-Jun;28(3):325-32. Epub 2010 Jun 23.
PubMed 20460034Fourrier-Reglat A, Cuong HM, Lassalle R, Depont F, Robinson P, Droz-Perroteau C, Pariente A, Begaud B, Blin P, Moore N. Concordance between prescriber- and patient-reported previous medical history and NSAID indication in the CADEUS cohort. Pharmacoepidemiol Drug Saf. 2010 May;19(5):474-81. doi: 10.1002/pds.1951.
PubMed 20437457Colver AF, Dickinson HO; SPARCLE group. Study protocol: determinants of participation and quality of life of adolescents with cerebral palsy: a longitudinal study (SPARCLE2). BMC Public Health. 2010 May 26;10:280. doi: 10.1186/1471-2458-10-280.
PubMed 20504349Colver AF, Dickinson HO, Parkinson K, Arnaud C, Beckung E, Fauconnier J, Marcelli M, McManus V, Michelsen SI, Parkes J, Thyen U. Access of children with cerebral palsy to the physical, social and attitudinal environment they need: a cross-sectional European study. Disabil Rehabil. 2011;33(1):28-35. doi: 10.3109/09638288.2010.485669. Epub 2010 May 6.
PubMed 20446803Fauconnier J, Pasquie JL, Bideaux P, Lacampagne A, Richard S. Cardiomyocytes hypertrophic status after myocardial infarction determines distinct types of arrhythmia: role of the ryanodine receptor. Prog Biophys Mol Biol. 2010 Sep;103(1):71-80. doi: 10.1016/j.pbiomolbio.2010.01.002. Epub 2010 Jan 28.
PubMed 20109482Fauconnier J, Thireau J, Reiken S, Cassan C, Richard S, Matecki S, Marks AR, Lacampagne A. Leaky RyR2 trigger ventricular arrhythmias in Duchenne muscular dystrophy. Proc Natl Acad Sci U S A. 2010 Jan 26;107(4):1559-64. doi: 10.1073/pnas.0908540107. Epub 2010 Jan 4.
PubMed 20080623Casez P, Labarere J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, Francois P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.
PubMed 19959332Mansen A, Tiselius C, Sand P, Fauconnier J, Westerblad H, Rydqvist B, Vennstrom B. Thyroid hormone receptor alpha can control action potential duration in mouse ventricular myocytes through the KCNE1 ion channel subunit. Acta Physiol (Oxf). 2010 Feb;198(2):133-42. doi: 10.1111/j.1748-1716.2009.02052.x. Epub 2009 Oct 14.
PubMed 19832729Messing B, Man F, Therond P, Hanh T, Thuillier F, Rambaud JC. Selenium status prior to and during one month total parenteral nutrition in gastroenterological patients: A randomised study of two dosages of Se supplementation. Clin Nutr. 1990 Oct;9(5):281-8. doi: 10.1016/0261-5614(90)90037-s.
PubMed 16837371
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maâthermes a Randomised Controlled Trial of Spa Treatment of Overweight and Obesity
- ClinicalTrials.gov ID
- NCT01258114
- Acronym / sponsor ID
- MAATHERMES / MAATHERMES
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Balneotherapy, Spa Therapy, balneology, hydrotherapy, SF 12, Nutritional counselling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- Université Joseph Fourier, Université Victor Segalen Bordeaux 2, HAT Consultant, AXONAL S.A.
- Study start
- Mar 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPA treatment (ST) | Active comparator | Other: 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). |
| Non SPA treatment (NST) | Sham comparator | 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) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Previous spa therapy for weight problems
- Pregnancy
- Major eating disorders (compulsive over eating)
- Poor french proficiency
- Involvement in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | SPA treatment (ST) |
| 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) |
Primary outcome
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
2 secondary outcomes
Patients achieving a weight loss of 5%
Time frame: 14 months
Quality of life : assessed by SF12
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
- Background: PubMed 18410773Peneau S, Thibault H, Meless D, Soulie D, Carbonel P, Roinsol D, Longueville E, Serog P, Deheeger M, Bellisle F, Maurice-Tison S, Rolland-Cachera MF. Anthropometric and behavioral patterns associated with weight maintenance after an obesity treatment in adolescents. J Pediatr. 2008 May;152(5):678-84. doi: 10.1016/j.jpeds.2007.09.053. Epub 2007 Nov 26.
- Background: PubMed 14968129Rolland-Cachera MF, Thibault H, Souberbielle JC, Soulie D, Carbonel P, Deheeger M, Roinsol D, Longueville E, Bellisle F, Serog P. Massive obesity in adolescents: dietary interventions and behaviours associated with weight regain at 2 y follow-up. Int J Obes Relat Metab Disord. 2004 Apr;28(4):514-9. doi: 10.1038/sj.ijo.0802605.
- Background: PubMed 20964259Marcellin P, Cadranel JF, Fontanges T, Poynard T, Pol S, Trepo C, Blin P, Bregman B, Schmidely N, Roudot-Thoraval F, Zarski JP. High rate of adefovir-lamivudine combination therapy in nucleoside-naive patients with chronic hepatitis B in France: results of a national survey in 1730 patients. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1290-6. doi: 10.1097/meg.0b013e32832fba4f.
- Background: PubMed 20861835Fourrier-Reglat A, Lacoin L, Pariente A, Lassalle R, Robinson P, Droz-Perroteau C, Begaud B, Blin P, Moore ND. When patients report diseases that prescribers seem unaware of: discordance between patient and physician reporting of risk-related previous history in NSAID users from the CADEUS study. Clin Pharmacol Ther. 2010 Nov;88(5):668-75. doi: 10.1038/clpt.2010.166. Epub 2010 Sep 22.
- Background: PubMed 20716243Blin P, Blazejewski S, Lignot S, Lassalle R, Bernard MA, Jayles D, Theophile H, Benichou J, Demeaux JL, Ebbo D, Franck J, Moride Y, Peyramond D, Rouveix B, Sturkenboom M, Gehanno P, Droz C, Moore N. Effectiveness of antibiotics for acute sinusitis in real-life medical practice. Br J Clin Pharmacol. 2010 Sep;70(3):418-28. doi: 10.1111/j.1365-2125.2010.03710.x.
- Background: PubMed 20460034Saraux A, Combe B, Blin P, Bregman B, Chartier M, Durieux-Mehlman S, Guillemin F. Survey of the therapeutic management of rheumatoid arthritis in France: the OPALE study. Clin Exp Rheumatol. 2010 May-Jun;28(3):325-32. Epub 2010 Jun 23.
- Background: PubMed 20437457Fourrier-Reglat A, Cuong HM, Lassalle R, Depont F, Robinson P, Droz-Perroteau C, Pariente A, Begaud B, Blin P, Moore N. Concordance between prescriber- and patient-reported previous medical history and NSAID indication in the CADEUS cohort. Pharmacoepidemiol Drug Saf. 2010 May;19(5):474-81. doi: 10.1002/pds.1951.
- Background: PubMed 20504349Colver AF, Dickinson HO; SPARCLE group. Study protocol: determinants of participation and quality of life of adolescents with cerebral palsy: a longitudinal study (SPARCLE2). BMC Public Health. 2010 May 26;10:280. doi: 10.1186/1471-2458-10-280.
- Background: PubMed 20446803Colver AF, Dickinson HO, Parkinson K, Arnaud C, Beckung E, Fauconnier J, Marcelli M, McManus V, Michelsen SI, Parkes J, Thyen U. Access of children with cerebral palsy to the physical, social and attitudinal environment they need: a cross-sectional European study. Disabil Rehabil. 2011;33(1):28-35. doi: 10.3109/09638288.2010.485669. Epub 2010 May 6.
- Background: PubMed 20109482Fauconnier J, Pasquie JL, Bideaux P, Lacampagne A, Richard S. Cardiomyocytes hypertrophic status after myocardial infarction determines distinct types of arrhythmia: role of the ryanodine receptor. Prog Biophys Mol Biol. 2010 Sep;103(1):71-80. doi: 10.1016/j.pbiomolbio.2010.01.002. Epub 2010 Jan 28.
- Background: PubMed 20080623Fauconnier J, Thireau J, Reiken S, Cassan C, Richard S, Matecki S, Marks AR, Lacampagne A. Leaky RyR2 trigger ventricular arrhythmias in Duchenne muscular dystrophy. Proc Natl Acad Sci U S A. 2010 Jan 26;107(4):1559-64. doi: 10.1073/pnas.0908540107. Epub 2010 Jan 4.
- Background: PubMed 19959332Casez P, Labarere J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, Francois P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick SEROG, MD principal investigator
Hospital PARIS
Thierry HANH, MD study director
PARIS HAT Consultant
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPA treatment (ST) and Non SPA treatment (NST) in people with Overweight and Obesity, run by Association Francaise pour la Recherche Thermale at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258114, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.