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

NCT04217395 | Unknown

• 1 other identifier: Eval-Xailes_2019
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Obesity; Overweight; Empowerment; Autonomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Reinforced support: X-ailes program users

Behavioral: Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator)

Interventions

Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator) BEHAVIORAL

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.

Reinforced support: X-ailes program users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects are the overweight or obese care health users followed-up byincluded in the X-Ailes program.

You may qualify if:

• 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

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

metropolitan area of Lyon

Lyon, France

Location

MeSH Terms

Conditions

Obesity; Overweight; Empowerment

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 3, 2020
• Study Start: May 27, 2020
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

FR (1)