NCT03578757

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

March 26, 2018

Last Update Submit

November 6, 2018

Conditions

ObesityStress

Keywords

stresspreventionobesityspapsychologybiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (33)

  • skin conductance

    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

    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

    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

    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

    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.

  • +28 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

stress management program and the same usual practice (restrictive diet, physical activity and thermal spa treatment)

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

Behavioral: 21-day residential program

Interventions

21-day residential programBEHAVIORAL

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.

intervention groupusual practice group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Participant refusal to participate
  • Pregnant and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 31874865DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic DUTHEIL

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

July 6, 2018

Study Start

February 1, 2019

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

FR(1)