ObesityEval-XailesNCT04217395
Quality of Life and Autonomy in Health of Overweight or Obese People Receiving Reinforced Support
An observational study of Obesity, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2020to 27 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects are the overweight or obese care health users followed-up byincluded in the X-Ailes program.
Who may be able to join
- 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
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator)
- Keywords
- Obesity, Overweight, Empowerment, Autonomy
- Medical subject headings
- Obesity, Overweight, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reinforced support: X-ailes program users | Not described Receives: Behavioral: Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start27 May 2020
- Primary completion27 May 2024 (estimated)
- Study completion27 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217395
- Sponsor's protocol ID
- Eval-Xailes_2019
- Acronym
- Eval-Xailes
- Status last verified
- Aug 2023
- First submitted
- 20 Dec 2019
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04217395
- Acronym / sponsor ID
- Eval-Xailes / Eval-Xailes_2019
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Empowerment, Autonomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 27 May 2024 (estimated)
- Study completion
- 27 May 2024 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects are the overweight or obese care health users followed-up byincluded in the X-Ailes program.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Reinforced support: X-ailes program users |
Primary outcome
Quality of life at 12 months, measured by the specific questionnaire Quality of life, Obesity and Dietetics (QOLOD, Ziegler et al. 2005)
Time frame: month 12
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life at 12 months, measured by the specific questionnaire Quality of life, Obesity and Dietetics (QOLOD, Ziegler et al. 2005) (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.