Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)Feels-MiciNCT07383844
Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), run by Fondation Lenval at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
- What is being tested?
- IMPACT-III questionnaires, Data collection: CAPAS-Q and semi-structured interview
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, 06000
Aline JOULIE, +33.4.92.03.05.20, joulie.a@chu-nice.fr
olivier Courbette, +33 4 92 03 05 65, olivier.courbette@hpu.lenval.com
About this study
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.
- Being tested
- IMPACT-III questionnaires, Data collection: CAPAS-Q, semi-structured interview
- Keywords
- physical activity
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT-III questionnairesOther
Participants complete the self-administered questionnaires IMPACT-III)
Data collection: CAPAS-QOther
Participants complete the self-administered questionnaires CAPAS-Q.
semi-structured interviewOther
participate in a semi-structured interview about perceived barriers and facilitators to physical activity. No counseling, training, or treatment is provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IMPACT-III questionnaires; Other: Data collection: CAPAS-Q; Other: semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived barriers and facilitators to regular physical activity
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.
Measured: at the inclusion
Secondary outcomes (2)
Physical activity level and sedentary behavior (CAPAS-Q)
Measured using the CAPAS-Q self-administered questionnaire to describe participants' physical activity and sedentary behavior.
Measured: at the inclusion
Health-related quality of life (IMPACT-III)
Measured using the IMPACT-III self-administered questionnaire to assess health-related quality of life in pediatric IBD.
Measured: at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start21 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)Studies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383844
- Sponsor's protocol ID
- 25-HPNCL-08 Feels-MICI
- Other IDs
- 2025-A02019-40
- Acronym
- Feels-Mici
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT07383844
- Acronym / sponsor ID
- Feels-Mici / 25-HPNCL-08 Feels-MICI
- Keywords
- physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Feb 2026 (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 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric IBD participants (questionnaires + interview) | – | Other: IMPACT-III questionnaires, Other: Data collection: CAPAS-Q, Other: semi-structured interviewThis 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| IMPACT-III questionnairesParticipants complete the self-administered questionnaires IMPACT-III) | Other | Pediatric IBD participants (questionnaires + interview) |
| Data collection: CAPAS-QParticipants complete the self-administered questionnaires CAPAS-Q. | Other | Pediatric IBD participants (questionnaires + interview) |
| semi-structured interviewparticipate in a semi-structured interview about perceived barriers and facilitators to physical activity. No counseling, training, or treatment is provided. | Other | Pediatric IBD participants (questionnaires + interview) |
Primary outcome
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.
2 secondary outcomes
Physical activity level and sedentary behavior (CAPAS-Q)
Time frame: at the inclusion
Health-related quality of life (IMPACT-III)
Time frame: at the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
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 Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), run by Fondation Lenval 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALINE JOULIE (0492030520 ext. +33, joulie.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived barriers and facilitators to regular physical activity (time frame: at the inclusion). 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 3 Feb 2026.