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Cardiovascular medicine
Protocol
Stress management in obesity during a thermal spa residential programme (ObesiStress): protocol for a randomised controlled trial study
  1. Frédéric Dutheil1,
  2. Elodie Chaplais2,3,
  3. Audrey Vilmant1,
  4. Daniel Courteix4,
  5. Pascale Duche5,
  6. Armand Abergel6,
  7. Daniela M Pfabigan7,
  8. Shihui Han7,
  9. Laurie Mobdillon8,
  10. Guillaume T Vallet8,
  11. Martial Mermillod9,10,
  12. Gil Boudet1,
  13. Philippe Obert11,
  14. Omar Izem11,
  15. Magalie Miolanne-Debouit12,
  16. Nicolas Farigon12,
  17. Bruno Pereira3,
  18. Yves Boirie13
  1. 1 Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France
  2. 2 Université de Lorraine, Laboratory “Development, Adaption and Disability” (DevAH - EA 3450), Nancy, France
  3. 3 University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Biostatistics Unit, Clinical research and Innovation Department (DRCI), Biostatistics, Clermont-Ferrand, France
  4. 4 Université Clermont Auvergne, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P - EA 3533), Clermont-Ferrand, France
  5. 5 Université de Toulon, Laboratory of Impact of Physical Activity on Health (IAPS), Toulon, France
  6. 6 Université Clermont Auvergne, CNRS, UMR 6284, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Hepatology Gastroenterology, Clermont-Ferrand, France
  7. 7 School of Psychological and Cognitive Sciences, PKU-IDG/McGovern Institute for Brain Research, Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China
  8. 8 Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, Clermont-Ferrand, France
  9. 9 Université Grenoble Alpes, Université Savoie Mont Blanc, LPNC, CNRS, Grenoble, France
  10. 10 Institut Universitaire de France, Paris, France
  11. 11 Université d’Avignon, Laboratory of Cardiovascular Pharm-ecology (LaPEC EA4278), Avignon, France
  12. 12 University Hospital of Clermont–Ferrand, CHU Clermont–Ferrand, Unit of Human Nutrition, Clermont-Ferrand, France
  13. 13 Université Clermont Auvergne, INRA, CRNH, University Hospital of Clermont–Ferrand, CHU Clermont–Ferrand, Unit of Human Nutrition, Clermont-Ferrand, France
  1. Correspondence to Dr Elodie Chaplais; elodie.chaplais{at}acu.edu.au

Abstract

Introduction Stress and obesity are two public health issues. The relationship between obesity and stress is biological through the actions of stress on the major hormones that regulate appetite (leptin and ghrelin). Many spa resorts in France specialise in the treatment of obesity, but no thermal spa currently proposes a specific programme to manage stress in obesity. The ObesiStress protocol has been designed to offer a new residential stress management programme. This thermal spa treatment of obesity implements stress management strategies as suggested by international recommendations.

Methods and analysis 140 overweight or obese participants with a Body Mass Index of >25 kg/m2 and aged over 18 years will be recruited. Participants will be randomised into two groups: a control group of usual practice (restrictive diet, physical activity and thermal spa treatment) and an intervention group with stress management in addition to the usual practice. In the present protocol, parameters will be measured on five occasions (at inclusion, at the beginning of the spa (day 0), at the end of the spa (day 21), and at 6 and 12 months). The study will assess the participants’ heart rate variability, cardiac remodelling and function, electrodermal activity, blood markers, anthropometric profile, body composition, psychology and quality of life via the use of questionnaires and bone parameters.

Ethics and dissemination The ObesiStress protocol complies with the ethics guidelines for Clinical Research and has been approved by the ethics committee (CPP Sud-Est VI, Clermont-Ferrand - ANSM: 2016-A01774-47). This study aimed to highlight the efficacy of a 21-day thermal spa residential programme of stress management in obesity through objective measurements of well-being and cardiovascular morbidity. Results will be disseminated during several research conferences and articles published in peer-reviewed journals.

Trial registration number NCT03578757.

  • obesity
  • stress
  • prevention
  • heart rate variability
  • spa bath

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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http://dx.doi.org/10.1136/bmjopen-2018-027058

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    Footnotes

    • Contributors FD contributed to the study design. FD was responsible for the submission of the protocol to the ethics committee. FD and AV coordinated the recruitment of patients. DC, EC and PD were responsible for bone measurements. AA was responsible for liver-related factors. DMP and SH were responsible for the psychosocial analysis. LM and MM were responsible for mindfulness, psychological education and cognitive-compartmental therapy analysis. GTV was responsible for the analysis of memory-related data. PO, OI and GB were responsible for cardiovascular measurements. YB, NF and MM-D were responsible for nutritional measurements and analysis. DC, EC and PD were responsible for physical activity analysis. AV was responsible for the collection of psychological factors. BP was responsible for the statistical analysis. EC was responsible for the clinical trial and wrote the first draft of this manuscript. All authors read and contributed to and approved the final manuscript.

    • Funding The study is integrally funded by the Auvergne Rhône-Alpes, the University Hospital of Clermont-Ferrand and by the European Regional Development Fund (Fonds Europeen de Développement Economique et Régional). The funding sources had no role in the design, conduct, or reporting of the study.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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    © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.