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NCT Number: NCT05224193

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

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

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Key information

Conditions

Inflammatory Bowel Diseases Behavior Digestive System Diseases Exercise Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Motor Activity

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location status: Recruiting

Location contact

Christopher Roberts, MBBS

CONTACT

[email protected]

Nadeem Afzal, MD

CONTACT

[email protected]

02381208546

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

Primary outcomes

  1. Moderate Vigorous Physical Activity measurement

    Time frame: Over 1 Week

    Amount of time spent performing moderate and vigorous physical activity

  2. Sedentary time

    Time frame: 1 week

    Amount of time spent sedentary

Secondary outcomes

  1. Disease Activity

    Time frame: At Baseline Clinical Assessment

    Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease

  2. Perceived Physical Activity

    Time frame: At Baseline Clinical Assessment

    Youth Physical Activity Scale - Subjective Assessment of Moderate Vigorous Physical Activity in Hours over a 1 week retrospective period

  3. Amount and Quality of Sleep

    Time frame: 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

  4. Nutritional Assessment

    Time frame: At Baseline Clinical Assessment

    Mid Upper Arm Circumference

  5. Growth Assessment

    Time frame: At Baseline Clinical Assessment

    Height in meters

  6. Growth Assessment

    Time frame: At Baseline Clinical Assessment

    Weight in kg

  7. Nutrition Assessment

    Time frame: 3 day assessment after baseline visit

    3 day self-reported food diary

  8. Amount and Quality of Sleep

    Time frame: 1 week period

    Accelerometer measured sleep

Other outcomes

  1. Quality of Life Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: ACTIVE-IBD

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Feb 4, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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