- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383844
Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases (Feels-Mici)
January 26, 2026 updated by: Fondation Lenval
This study aims to identify perceived barriers and facilitators to regular physical activity among children and adolescents with inflammatory bowel disease (IBD) followed in pediatric gastroenterology.
Approximately 60 participants aged 10-17 years will complete two self-administered questionnaires (CAPAS-Q for physical activity/sedentary behavior and IMPACT-III for health-related quality of life) and take part in a single semi-structured interview exploring experiences, obstacles, and levers to support sustainable physical activity.
Relevant clinical data (disease characteristics, treatment and selected routine clinical parameters) will be extracted from the medical record.
Participation is limited to one visit (about 45-60 minutes) during a routine hospital appointment, with no additional intervention or follow-up required.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ALINE JOULIE
- Phone Number: +33 0492030520
- Email: joulie.a@chu-nice.fr
Study Contact Backup
- Name: Olivier Courbette
- Phone Number: +33 +33.4.92.03.05.65
- Email: olivier.courbette@hpu.lenval.com
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
-
Contact:
- Aline JOULIE
- Phone Number: +33.4.92.03.05.20
- Email: joulie.a@chu-nice.fr
-
Contact:
- olivier Courbette
- Phone Number: +33 4 92 03 05 65
- Email: olivier.courbette@hpu.lenval.com
-
Principal Investigator:
- olivier Courbette, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Aged 10 to 17 years at inclusion.
- Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis) confirmed and diagnosed for at least 6 months.
- Followed in the pediatric gastroenterology department at Hôpital Lenval (CHU de Nice).
- Sufficient cognitive and language abilities to understand questionnaires and participate in an individual interview.
Description
Inclusion Criteria:
- Aged 10 to 17 years at inclusion.
- Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis) confirmed and diagnosed for at least 6 months.
- Followed in the pediatric gastroenterology department at Hôpital Lenval (CHU de Nice).
- Sufficient cognitive and language abilities to understand questionnaires and participate in an individual interview.
- Affiliated to, or beneficiary of, a social security scheme.
- no parental objection to participation (non-opposition).
Exclusion Criteria:
- Younger than 10 years or older than 17 years.
- No IBD diagnosis, or IBD diagnosed less than 6 months ago.
- Associated chronic condition (neurological, metabolic, psychiatric, or other) likely to interfere with questionnaire completion or interview participation.
- Major language or cognitive impairment preventing adequate understanding or interview participation.
- Not affiliated to, or not beneficiary of, a social security scheme.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric IBD participants (questionnaires + interview)
This study does not involve any therapeutic or behavioral intervention.
The "intervention" corresponds to data collection during a single visit: participants complete two self-administered questionnaires (CAPAS-Q and IMPACT-III) and participate in a semi-structured interview about perceived barriers and facilitators to physical activity.
No counseling, training, or treatment is provided.
|
Participants complete the self-administered questionnaires IMPACT-III)
Participants complete the self-administered questionnaires CAPAS-Q.
participate in a semi-structured interview about perceived barriers and facilitators to physical activity.
No counseling, training, or treatment is provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived barriers and facilitators to regular physical activity
Time Frame: at the inclusion
|
Assessed through a single semi-structured interview.
Qualitative thematic analysis will be used to identify and categorize perceived barriers and facilitators to regular physical activity in pediatric IBD.
|
at the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity level and sedentary behavior (CAPAS-Q)
Time Frame: at the inclusion
|
Measured using the CAPAS-Q self-administered questionnaire to describe participants' physical activity and sedentary behavior.
|
at the inclusion
|
|
Health-related quality of life (IMPACT-III)
Time Frame: at the inclusion
|
Measured using the IMPACT-III self-administered questionnaire to assess health-related quality of life in pediatric IBD.
|
at the inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
January 26, 2026
First Submitted That Met QC Criteria
January 26, 2026
First Posted (Actual)
February 3, 2026
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-HPNCL-08 Feels-MICI
- 2025-A02019-40 (Other Identifier: id-rcb)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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