NCT07383844

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 21, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

physical activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    at the inclusion

Secondary Outcomes (2)

  • Physical activity level and sedentary behavior (CAPAS-Q)

    at the inclusion

  • Health-related quality of life (IMPACT-III)

    at the inclusion

Study Arms (1)

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.

Other: IMPACT-III questionnairesOther: Data collection: CAPAS-QOther: semi-structured interview

Interventions

Participants complete the self-administered questionnaires IMPACT-III)

Pediatric IBD participants (questionnaires + interview)

Participants complete the self-administered questionnaires CAPAS-Q.

Pediatric IBD participants (questionnaires + interview)

participate in a semi-structured interview about perceived barriers and facilitators to physical activity. No counseling, training, or treatment is provided.

Pediatric IBD participants (questionnaires + interview)

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, UlcerativeMotor Activity

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesBehavior

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

January 21, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations