ObesityObesiStressNCT03578757
Stress Management in Obesity During a Thermal Spa Residential Program
A study testing 21-day residential program in people with Obesity and Stress, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- 21-day residential program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 1 Apr 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Participant refusal to participate
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Frederic DUTHEIL
About this study
Official title: Stress Management in Obesity During a Thermal Spa Residential Program: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- 21-day residential program
- Keywords
- stress, prevention, obesity, spa, psychology, biomarkers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21-day residential programBehavioural
Both groups will benefit of a 21-day residential program at the thermal spa resort combining corrections of eating disorders (and a negative energy balance of 500 kcal/day), physical activity (2h30 per day, minimum), thermal spa treatment (2h per day, minimum), and health education (1h30 per day, minimum: cooking, nutrition and physical activity classes…). Physical activity will be diverse (endurance, strength, circuit training) and personalized to the target of each participant.
The intervention group will benefit from psychological interventions based on validated approaches of stress (3 x 1h30 per week). Participants will attend psychological sessions by group of less than 10 individuals. Individual meeting with the psychologist will occur at least twice: at the beginning of the residential program and at the end.
After the spa residential program, participants will undergo a one-year at-home follow-up.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | stress management program and the same usual practice (restrictive diet, physical activity and thermal spa treatment) Receives: Behavioral: 21-day residential program |
| usual practice group | Active comparator | Both groups will benefit of a 21-day residential program at the thermal spa resort combining corrections of eating disorders Receives: Behavioral: 21-day residential program |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability (biomarker of both stress and morbidity/mortality)
To assess the ability of a short spa residential program of management of work-related stress in increasing heart rate variability, a biomarker of both stress and morbidity/mortality.
Heart rate variability will be measured by zephyr during 26h recording time
Measured: 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 (33)
skin conductance
skin conductance will be measured using Wirst band electrodes
Measured: 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.
blood flow velocity
blood flow velocity will be measured using laser speckle contrast imaging
Measured: 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
myocardial longitudinal strain
myocardial longitudinal strain will be measured using speckle tracking echocardiography
Measured: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at six months
Genetic polymorphisms related to stress
Genetic polymorphisms related to stress will be measured using blood cells (angiotensin converting enzyme and serotonin)
Measured: 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
Demographics information
Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events
Measured: 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.
Anthropometry
Anthropometry parameters will be obtained according to the ISAK recommendations
Measured: 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
Body composition
Body composition (muscle and fat) will be measured using Impedancemeter
Measured: 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
Body composition
Body composition (muscle and fat) will be measured using dual x-ray absorption
Measured: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year
bone microarchitecture
bone microarchitecture will be measured using peripheral quantitative computed tomography
Measured: 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.
bone mass
bone mass will be measured using dual x-ray absorption
Measured: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year.
bone mass
bone mass will be measured using quantitative ultrasounds
Measured: 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.
General Health
General Health will be measured using the General Health Questionnaire, (there is no score, just informative health information)
Measured: 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.
Physical Activity
Physical Activity will be measured using the Recent Physical Activity Questionnaire (All activities are categorised depending on intensity: sedentary (<1.5 MET); light (1.5 to <3 MET), moderate-to-vigorous (>3MET))Questionnaire
Measured: 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.
Depression and anxiety
Depression and anxiety will be measured using the Hospital anxiety and depression scale (scale range from 0 to 3, with a total score between 0 to 21. Threshold score is 8
Measured: 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
Burn-out
Burn-out will be measured using the Maslach Burn Out Inventory (scale range from 0 to 6, with 0 = never and 6 = almost always)
Measured: 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.
Job content
Job content will be measured using the Karasek questionnaire (scale range from 1 to 4, with 1= not agreed and 4 = totally agreed)
Measured: 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
anxiety
anxiety will be measured using the state and trait anxiety inventory scale (scale range from 1 to 4, with a total score between 20 to 80. If <35 poor level of anxiety, if > 66 very high level of anxiety)
Measured: 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
mindfulness
mindfulness will be measured using the Freiburg mindfulness inventory scale (scale range from 1 to 4, with 1 = almost never, 4 = almost always)
Measured: 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.
self-efficacy
self-efficacy will be measured using the perceived self-efficacy scale (scale range from 1 to 4, with 1= wrong and 4 = true)
Measured: 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
Alexithymia
Alexithymia will be measured using the Toronto Alexithymia scale (scale range from 1 to 5, with 1 = not agreed, 5 = totally agreed)
Measured: 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
coping responses
coping responses will be measured using the brief COPE questionnaire (scale range from 1 to 4, with 1 = not agreed, 4 = totally agreed)
Measured: 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
emotion regulation
emotion regulation will be measured using the emotion regulation questionnaire (scale range from 1 to 7, with 1 = not agreed, 7 = totally agreed)
Measured: 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.
metacognition
metacognition will be measured using the metacognition questionnaire MQC-30 (scale range from 1 to 4, with 1 = not agreed, 4 = totally agreed)
Measured: 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
illness perception
illness perception will be measured using the brief illness perception questionnaire (B-IPQ 9 items, scale range from 0 to 10)
Measured: 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
lifestyle behaviours
lifestyle behaviours will be measured using the lifestyle questionnaire
Measured: 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
workplace stress
workplace stress will be measured using the Inner Correspondence/Peaceful Harmony with practices - ICPH (17 items, a 5-point scale from disagreement to agreement, scores >50% indicate higher agreement while scores <50 indicate disagreement).
Measured: : 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.
Basic biology
HbA1c (mmol/mol) will be measured using endocrine assays
Measured: 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.
appetite markers
Leptin (ng/mL) will be measured using endocrine assays
Measured: 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.
Pro-inflammatory cytokine
IL-1β will be measured using endocrine assays
Measured: 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
Telomeres length
Telomeres length will be measured using endocrine assays
Measured: 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
stress markers
Cortisol (nmol/l) will be measured using endocrine assays
Measured: 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.
adrenal function
adrenal function will be measured using endocrine assays (Dehydroepiandrosterone - DHEAS)
Measured: 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.
neurotrophic factors
neurotrophic factors will be measured using endocrine assays (Brain-Derived Neurotrophic Factor -BDNF)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Council of Auvergne-Rhône-Alpes, European Regional Development Fund, Spa resort of Vichy, Compagnie de Vichy, 1 et 3 avenue Eisenhower, 03200 Vichy, France, Hospital of Vichy, Boulevard Denière, 03200 Vichy, France, Université d'Auvergne, LaPEC laboratory (EA 4278), Avignon University, Avignon, France, Innovatherm, Center of Auvergne for Obesity and its health-related risks (CALORIS), Auvergne, France
- Responsible party
- Sponsor
- Investigators
- Frederic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578757
- Sponsor's protocol ID
- CHU-385
- Other IDs
- 2016 A01774 47
- Acronym
- ObesiStress
- Status last verified
- Nov 2018
- First submitted
- 26 Mar 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31874865
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management in Obesity During a Thermal Spa Residential Program: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03578757
- Acronym / sponsor ID
- ObesiStress / CHU-385
- Keywords
- stress, prevention, obesity, spa, psychology, biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Regional Council of Auvergne-Rhône-Alpes, European Regional Development Fund, Spa resort of Vichy, Compagnie de Vichy, 1 et 3 avenue Eisenhower, 03200 Vichy, France, Hospital of Vichy, Boulevard Denière, 03200 Vichy, France, Université d'Auvergne, LaPEC laboratory (EA 4278), Avignon University, Avignon, France, Innovatherm, Center of Auvergne for Obesity and its health-related risks (CALORIS), Auvergne, France
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: 21-day residential programstress management program and the same usual practice (restrictive diet, physical activity and thermal spa treatment) |
| usual practice group | Active comparator | Behavioral: 21-day residential programBoth groups will benefit of a 21-day residential program at the thermal spa resort combining corrections of eating disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Participant refusal to participate
- Pregnant and breastfeeding women
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 |
|---|---|---|
| 21-day residential programBoth groups will benefit of a 21-day residential program at the thermal spa resort combining corrections of eating disorders (and a negative energy balance of 500 kcal/day), physical activity (2h30 per day, minimum), thermal spa treatment (2h per day, minimum), and health education (1h30 per day, minimum: cooking, nutrition and physical activity classes…). Physical activity will be diverse (endurance, strength, circuit training) and personalized to the target of each participant. The intervention group will benefit from psychological interventions based on validated approaches of stress (3 x 1h30 per week). Participants will attend psychological sessions by group of less than 10 individuals. Individual meeting with the psychologist will occur at least twice: at the beginning of the residential program and at the end. After the spa residential program, participants will undergo a one-year at-home follow-up. | Behavioural | intervention group, usual practice group |
Primary outcome
heart rate variability (biomarker of both stress and morbidity/mortality)
Time frame: 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.
To assess the ability of a short spa residential program of management of work-related stress in increasing heart rate variability, a biomarker of both stress and morbidity/mortality. Heart rate variability will be measured by zephyr during 26h recording time
33 secondary outcomes
skin conductance
Time frame: 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.
blood flow velocity
Time frame: 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
myocardial longitudinal strain
Time frame: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at six months
Genetic polymorphisms related to stress
Time frame: 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
Demographics information
Time frame: 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.
Anthropometry
Time frame: 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
Body composition
Time frame: 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
Body composition
Time frame: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year
bone microarchitecture
Time frame: 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.
bone mass
Time frame: Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year.
bone mass
Time frame: 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.
General Health
Time frame: 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.
Physical Activity
Time frame: 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.
Depression and anxiety
Time frame: 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
Burn-out
Time frame: 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.
Job content
Time frame: 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
anxiety
Time frame: 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
mindfulness
Time frame: 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.
self-efficacy
Time frame: 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
Alexithymia
Time frame: 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
coping responses
Time frame: 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
emotion regulation
Time frame: 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.
metacognition
Time frame: 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
illness perception
Time frame: 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
lifestyle behaviours
Time frame: 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
workplace stress
Time frame: : 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.
Basic biology
Time frame: 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.
appetite markers
Time frame: 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.
Pro-inflammatory cytokine
Time frame: 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
Telomeres length
Time frame: 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
stress markers
Time frame: 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.
adrenal function
Time frame: 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.
neurotrophic factors
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Derived from this study: PubMed 31874865Dutheil 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.
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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.
Frederic DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 21-day residential program in people with Obesity and Stress, run by University Hospital, Clermont-Ferrand at 1 site 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (biomarker of both stress and morbidity/mortality) (time frame: 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.). 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 NCT03578757, which also lists 1 linked publication.
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 7 Nov 2018.