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Stress Management in Obesity During a Thermal Spa Residential Program (ObesiStress)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578757
Recruitment Status : Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : November 7, 2018
Sponsor:
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
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Obesity Stress Behavioral: 21-day residential program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Prevention
Official Title: Stress Management in Obesity During a Thermal Spa Residential Program: a Randomized Controlled Trial
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: intervention group
stress management program and the same usual practice (restrictive diet, physical activity and thermal spa treatment)
Behavioral: 21-day residential program

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.


Active Comparator: usual practice group
Both groups will benefit of a 21-day residential program at the thermal spa resort combining corrections of eating disorders
Behavioral: 21-day residential program

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.





Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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. ]
    skin conductance will be measured using Wirst band electrodes

  2. 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 ]
    blood flow velocity will be measured using laser speckle contrast imaging

  3. 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 ]
    myocardial longitudinal strain will be measured using speckle tracking echocardiography

  4. 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 ]
    Genetic polymorphisms related to stress will be measured using blood cells (angiotensin converting enzyme and serotonin)

  5. 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. ]
    Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events

  6. 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 ]
    Anthropometry parameters will be obtained according to the ISAK recommendations

  7. 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 (muscle and fat) will be measured using Impedancemeter

  8. 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 ]
    Body composition (muscle and fat) will be measured using dual x-ray absorption

  9. 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 microarchitecture will be measured using peripheral quantitative computed tomography

  10. 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 will be measured using dual x-ray absorption

  11. 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. ]
    bone mass will be measured using quantitative ultrasounds

  12. 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. ]
    General Health will be measured using the General Health Questionnaire, (there is no score, just informative health information)

  13. 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. ]
    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

  14. 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 ]
    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

  15. 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. ]
    Burn-out will be measured using the Maslach Burn Out Inventory (scale range from 0 to 6, with 0 = never and 6 = almost always)

  16. 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 ]
    Job content will be measured using the Karasek questionnaire (scale range from 1 to 4, with 1= not agreed and 4 = totally agreed)

  17. 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 ]
    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)

  18. 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. ]
    mindfulness will be measured using the Freiburg mindfulness inventory scale (scale range from 1 to 4, with 1 = almost never, 4 = almost always)

  19. 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 ]
    self-efficacy will be measured using the perceived self-efficacy scale (scale range from 1 to 4, with 1= wrong and 4 = true)

  20. 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 ]
    Alexithymia will be measured using the Toronto Alexithymia scale (scale range from 1 to 5, with 1 = not agreed, 5 = totally agreed)

  21. 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 ]
    coping responses will be measured using the brief COPE questionnaire (scale range from 1 to 4, with 1 = not agreed, 4 = totally agreed)

  22. 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. ]
    emotion regulation will be measured using the emotion regulation questionnaire (scale range from 1 to 7, with 1 = not agreed, 7 = totally agreed)

  23. 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 ]
    metacognition will be measured using the metacognition questionnaire MQC-30 (scale range from 1 to 4, with 1 = not agreed, 4 = totally agreed)

  24. 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 ]
    illness perception will be measured using the brief illness perception questionnaire (B-IPQ 9 items, scale range from 0 to 10)

  25. 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 ]
    lifestyle behaviours will be measured using the lifestyle questionnaire

  26. 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. ]
    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).

  27. 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. ]
    HbA1c (mmol/mol) will be measured using endocrine assays

  28. 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. ]
    Leptin (ng/mL) will be measured using endocrine assays

  29. 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 ]
    IL-1β will be measured using endocrine assays

  30. 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 ]
    Telomeres length will be measured using endocrine assays

  31. 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. ]
    Cortisol (nmol/l) will be measured using endocrine assays

  32. 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. ]
    adrenal function will be measured using endocrine assays (Dehydroepiandrosterone - DHEAS)

  33. 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. ]
    neurotrophic factors will be measured using endocrine assays (Brain-Derived Neurotrophic Factor -BDNF)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578757


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Frederic DUTHEIL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
Investigators
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Principal Investigator: Frederic DUTHEIL University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03578757    
Other Study ID Numbers: CHU-385
2016 A01774 47 ( Other Identifier: 2016 A01774 47 )
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
stress
prevention
obesity
spa
psychology
biomarkers
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight