Quality of Life and Autonomy in Health of Overweight or Obese People Receiving Reinforced Support

Obesity Clinical Trial

— Eval-Xailes  

Official title:

Implementation and Effectiveness of a Reinforced Support Program for People Who Are Overweight or Obese to Improve Their Autonomy in Health and Quality of Life

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04217395
• Other study ID #: Eval-Xailes_2019
• Status: Active, not recruiting
• Start date: May 27, 2020
• Est. completion date: May 27, 2024

Study information

• Verified date: August 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This mixed-methods prospective cohort study aims to evaluate a recently implemented reinforced support program named "X-ailes program".

The X-Ailes program is a face-to-face or telephone-based support program by health-system navigators/case-managers, funded by the French Ministry of Health (program for empowerment of care users). X-Ales is developed by an patients and public association to support overweight or obese care users facing difficulty to access to care or resources regarding the management of their health situation.

The subjects of the present study are the overweight or obese care-users followed-up by the X-Ailes program.

The aim of the study Eval-X-ailes is to assess the effect of the support program X-Ailes on quality of life, autonomy and literacy of overweight or obese care users at 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: May 27, 2024
• Est. primary completion date: May 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• People aged 18 or more, male or female

• Body mass index equal or over 25

• Resident Living in one of the 2 territories covered by the X-ailes program (Lyon Metropolitan Area or Puy-de-Dôme County)

• Starting Included in the X-ailes program support (1st phone contact to initiate follow-up)

• Not objecting to participating in the evaluation of the X-ailes program

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator)
The X-Ailes program is a face-to-face or telephone-based support program by health-system navigators and developed by a patients and public association to support overweight or obese care users. The main objective of the study is to evaluate the efficacy of the X-ailes program on quality of life of overweight and obese people involved in the program. Secondary objectives are to assess their overall health status, their health literacy level and their empowerment. The implementation study is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance; Glasgow, Vogt, & Boles, 1999) theoretical framework to determine whether the intervention objectives are being met and to understand the mechanisms of action of the device.

Locations

Country	Name	City	State
France	metropolitan area of Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life at 12 months, measured by the specific questionnaire Quality of life, Obesity and Dietetics (QOLOD, Ziegler et al. 2005)	The QOLOD questionnaire is adapted to socio-cultural factors of obesity and dietary weight management in France, and it is validated with satisfactory reliability and reproducibility. It contains 36 items grouped into 5 dimensions: physical impact, psycho-social impact, sex-life impact, comfort with food and diet experience. Answers for each question are expressed on a scale from 1 to 5, where 1 =enormously/all the time (true) and 5 = never/not at all (true). Score vary from 0 to 100. Global and dimension scores evolution will measure during the follow-up.	month 12