Clinical trial NCT03578757: Stress Management in Obesity During a Thermal Spa Residential Program
Official title: Stress Management in Obesity During a Thermal Spa Residential Program: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Stress
Keywords: stress
prevention
obesity
spa
psychology
biomarkers
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Regional Council of Auvergne-Rhône-Alpes
name: European Regional Development Fund
name: Spa resort of Vichy, Compagnie de Vichy, 1 et 3 avenue Eisenhower, 03200 Vichy, France
name: Hospital of Vichy, Boulevard Denière, 03200 Vichy, France
name: Université d'Auvergne
name: LaPEC laboratory (EA 4278), Avignon University, Avignon, France
name: Innovatherm
name: Center of Auvergne for Obesity and its health-related risks (CALORIS), Auvergne, France
First posted: 2018-07-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Stress can lead to obesity via inappropriate eating. In addition, obesity is a major stress factor. Furthermore, stressed people are also those who have the greatest difficulties to lose weight. The relationships between obesity and stress are biological via the action of stress on the major hormones regulating appetite (leptin, ghrelin). International recommendation proposals suggest to implement stress management programs in obesity for a sustainable weight loss. Moreover, stress and obesity are two public health issues. Among the multiple physical and psychological consequences of stress and obesity, increased mortality and cardiovascular morbidity seem the main concern. Many spa resorts are specialized in the treatment of obesity in France but actually no thermal spa proposes a specific program to manage stress in obesity.

The main hypothesis is that a thermal spa residential program (21 days) of stress management in obesity will exhibit its efficacy through objective measures of well-being and cardiovascular morbidity.

Detailed description: The Obesi-Stress protocol was designed to provide a better understanding of the effect of a spa residential program combined with a stress management program on the improvement of heart rate variability in the treatment of obesity.

In the present protocol, parameters are measured on five occasions (inclusion, at the start of the spa, at the end of the spa, at 6 months and at 12 months).

Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p\<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups.

Analysis will be performed using Student t-test or Mann-Whitney tests. Linear regression (with logarithmic transformation if necessary) considering an adjustment on covariates fixed according to univariate results, epidemiological relevance and observance to physical activity will complete the analysis. Comparisons of categorical variables will be performed using Chi-squared or Fischer test. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese participants with Body Mass Index (BMI) \>25 kg.m-2
* Spontaneously candidate to the spa program of Vichy for management of obesity
* Aged over 18 years old
* A stable weight during the last three months
* No hepatic, renal or endocrine diseases uncontrolled
* Ability to give a written informed consent -- Affiliated to French health care system (for France)

Exclusion Criteria:

* Participant refusal to participate
* Pregnant and breastfeeding women

Primary outcomes:
measure: heart rate variability (biomarker of both stress and morbidity/mortality)
timeFrame: HRV changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
Secondary outcomes:
measure: skin conductance
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: blood flow velocity
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: myocardial longitudinal strain
timeFrame: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at six months
measure: Genetic polymorphisms related to stress
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: Demographics information
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: Anthropometry
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: Body composition
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: Body composition
timeFrame: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year
measure: bone microarchitecture
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: bone mass
timeFrame: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year.
measure: bone mass
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: General Health
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: Physical Activity
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: Depression and anxiety
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: Burn-out
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: Job content
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: anxiety
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: mindfulness
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: self-efficacy
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: Alexithymia
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: coping responses
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: emotion regulation
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: metacognition
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: illness perception
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: lifestyle behaviours
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: workplace stress
timeFrame: : Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: Basic biology
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: appetite markers
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: Pro-inflammatory cytokine
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: Telomeres length
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year
measure: stress markers
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: adrenal function
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
measure: neurotrophic factors
timeFrame: Changes overtime is being assessed. Outcomes will be measured at inclusion, at the beginning of the spa program (day 0), day 21, at six months and at one year.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frederic DUTHEIL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dutheil F, Chaplais E, Vilmant A, Courteix D, Duche P, Abergel A, Pfabigan DM, Han S, Mobdillon L, Vallet GT, Mermillod M, Boudet G, Obert P, Izem O, Miolanne-Debouit M, Farigon N, Pereira B, Boirie Y. Stress management in obesity during a thermal spa residential programme (ObesiStress): protocol for a randomised controlled trial study. BMJ Open. 2019 Dec 23;9(12):e027058. doi: 10.1136/bmjopen-2018-027058.