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.
- heart rate variability
- spa bath
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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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