Actively Recruiting
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
Led by University Hospital Southampton NHS Foundation Trust · Updated on 2022-03-10
50
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying physical activity levels and sleep patterns in children and adolescents aged 6 to 18 years who have Inflammatory Bowel Disease (IBD). The study aims to understand how active these young patients are and whether they meet recommended physical activity guidelines. This observational study is conducted by the University Hospital Southampton NHS Foundation Trust and focuses on quality of life and disease impact in pediatric IBD patients. Participants will complete questionnaires about their physical activity, disease activity, and quality of life. They will also wear a wrist-based accelerometer for one week to monitor activity and sleep. During this period, they will keep a physical activity diary, food diary, and stool chart to provide detailed information about their daily habits and health. Throughout the study, researchers will assess moderate to vigorous physical activity and sedentary time over one week. Additional evaluations at baseline include disease activity, perceived physical activity, sleep quality, nutritional status, and growth measurements. Nutritional assessments will be repeated over a three-day period after the baseline visit. The total involvement includes wearing the device and completing diaries, with ongoing analysis of data to understand activity and health in pediatric IBD patients.
CONDITIONS
Brief Title
ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 6 to 18 years
- Confirmed diagnosis of Inflammatory Bowel Disease based on endoscopy or histology
- Under care of Southampton University Hospitals NHS Foundation Trust paediatric gastroenterology team
- Able to provide consent or assent to participate
- Able to understand and cooperate with study requirements
- Pregnant participants may be included if able to complete physical assessments
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week
Participants undergo baseline clinical assessments including disease activity, physical activity, sleep quality, nutritional and growth assessments.
1 baseline visit (in-person) and 3-day nutritional assessment
Duration - Up to 5 years
Participants are observed over a period of up to 5 years to monitor physical activity, sleep patterns, fitness, and quality of life.
Physical activity and sedentary time measured over 1 week, sleep assessed over 1 week
Trial Site Locations
Total: 1 location
1
Univeristy Hospital Southampton
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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