ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease

Sponsor

University Hospital Southampton NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT05224193

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of physical activity on children with Inflammatory Bowel Disease using questionnaires and wrist watch based activity monitors.

The participants will be recruited from paediatric IBD clinics and will undergo questionnaires to assess their activity level, disease activity and quality of life scores. The participants will then be invited to wear a wrist based accelerometer for a week. The participants will complete a physical activity diary, food diary and stool chart at the same time.

Results will be analysed to see the level of physical activity and assess if the participants are meeting the recommended level of physical activity

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Exercise

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Physical ACTIVity, slEep, Fitness and Quality of Life in Children and Adolescents With Inflammatory Bowel Disease: a 5-year Prospective Observational Cohort Study - The ACTIVE-IBD Study

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Paediatric Patients with Inflammatory Bowel Disease

Outcome Measures

Primary Outcome Measures

Moderate Vigorous Physical Activity measurement [Over 1 Week]
Amount of time spent performing moderate and vigorous physical activity
Sedentary time [1 week]
Amount of time spent sedentary

Secondary Outcome Measures

Disease Activity [At Baseline Clinical Assessment]
Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease
Perceived Physical Activity [At Baseline Clinical Assessment]
Youth Physical Activity Scale - Subjective Assessment of Moderate Vigorous Physical Activity in Hours over a 1 week retrospective period
Amount and Quality of Sleep [At Baseline Clinical Assessment]
Child Sleep Health Questionnaire scored out of 154 total and is parent/ carer subjective sleep assessment. Scored in four separate domains. Higher scores indicate increased duration and quality of sleep
Nutritional Assessment [At Baseline Clinical Assessment]
Mid Upper Arm Circumference
Growth Assessment [At Baseline Clinical Assessment]
Height in meters
Growth Assessment [At Baseline Clinical Assessment]
Weight in kg
Nutrition Assessment [3 day assessment after baseline visit]
3 day self-reported food diary
Amount and Quality of Sleep [1 week period]
Accelerometer measured sleep

Other Outcome Measures

Quality of Life Score [At baseline clinic assessment]
Paediatric Quality of Life Score - PEDSQL scored in psychosocial and physical sections. Both are scored out of 100 and the higher the score the better health related quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children/adolescents from age of 6 to 18 years of age
Confirmed endoscopic/histology based IBD diagnosis
Under the care of the Southampton University Hospitals NHS Foundation Trust paediatric gastroenterology team
Able to provide consent / assent to participate in the study
Able to understand and/or cooperate with the study requirements
Pregnant participants will be included as long as they can complete the physical assessmentsExclusion Criteria: