Stress Management in Obesity During a Thermal Spa Residential Program

Obesity Clinical Trial

— ObesiStress  

Official title:

Stress Management in Obesity During a Thermal Spa Residential Program: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03578757
• Other study ID #: CHU-385
• Secondary ID: 2016 A01774 47
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 49 63
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Stress

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (9)

Lead Sponsor

Collaborator

University Hospital, Clermont-Ferrand

Center of Auvergne for Obesity and its health-related risks (CALORIS), Auvergne, France, European Regional Development Fund, Hospital of Vichy, Boulevard Denière, 03200 Vichy, France, Innovatherm, LaPEC laboratory (EA 4278), Avignon University, Avignon, France, Regional Council of Auvergne-Rhône-Alpes, Spa resort of Vichy, Compagnie de Vichy, 1 et 3 avenue Eisenhower, 03200 Vichy, France, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	skin conductance	skin conductance will be measured using Wirst band electrodes	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	blood flow velocity	blood flow velocity will be measured using laser speckle contrast imaging	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	myocardial longitudinal strain	myocardial longitudinal strain will be measured using speckle tracking echocardiography	Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at six months
Secondary	Genetic polymorphisms related to stress	Genetic polymorphisms related to stress will be measured using blood cells (angiotensin converting enzyme and serotonin)	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	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	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	Anthropometry	Anthropometry parameters will be obtained according to the ISAK recommendations	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	Body composition	Body composition (muscle and fat) will be measured using Impedancemeter	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	Body composition	Body composition (muscle and fat) will be measured using dual x-ray absorption	Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year
Secondary	bone microarchitecture	bone microarchitecture will be measured using peripheral quantitative computed tomography	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	bone mass	bone mass will be measured using dual x-ray absorption	Changes overtime is being assessed. Outcomes will be measured at the beginning of the spa program (day 0) and at one year.
Secondary	bone mass	bone mass will be measured using quantitative ultrasounds	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	General Health	General Health will be measured using the General Health Questionnaire, (there is no score, just informative health information)	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	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	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	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	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	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)	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	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)	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	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)	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	mindfulness	mindfulness will be measured using the Freiburg mindfulness inventory scale (scale range from 1 to 4, with 1 = almost never, 4 = almost always)	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	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)	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	Alexithymia	Alexithymia will be measured using the Toronto Alexithymia scale (scale range from 1 to 5, with 1 = not agreed, 5 = totally agreed)	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	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)	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	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)	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	metacognition	metacognition will be measured using the metacognition questionnaire MQC-30 (scale range from 1 to 4, with 1 = not agreed, 4 = totally agreed)	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	illness perception	illness perception will be measured using the brief illness perception questionnaire (B-IPQ 9 items, scale range from 0 to 10)	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	lifestyle behaviours	lifestyle behaviours will be measured using the lifestyle questionnaire	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	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).	: 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	Basic biology	HbA1c (mmol/mol) will be measured using endocrine assays	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	appetite markers	Leptin (ng/mL) will be measured using endocrine assays	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	Pro-inflammatory cytokine	IL-1ß will be measured using endocrine assays	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	Telomeres length	Telomeres length will be measured using endocrine assays	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	stress markers	Cortisol (nmol/l) will be measured using endocrine assays	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	adrenal function	adrenal function will be measured using endocrine assays (Dehydroepiandrosterone - DHEAS)	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	neurotrophic factors	neurotrophic factors will be measured using endocrine assays (Brain-Derived Neurotrophic Factor -BDNF)	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.