NCT04610918

Comparing Body Composition Assessment Methods

Completed Last updated 2 March 2023

What this trial tests

trial in Body Composition in 70 participants. Completed in 31 December 2022.

Timeline

20 October 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	The Hospital for Sick Children
Status	Completed
Study type	OBSERVATIONAL
Enrollment	70
Start date	20 October 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Canada

Conditions studied

• Body Composition — all drugs for Body Composition →
• Gastrointestinal Failure — all drugs for Gastrointestinal Failure →
• Pediatric ALL — all drugs for Pediatric ALL →

Sponsor

The Hospital for Sick Children

Who can join

Adults 1 to 18, any sex, with Body Composition or Gastrointestinal Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Improvement in clinical care has resulted in longer life expectancy of children with intestinal failure (IF). However, recent data indicate that their body composition (BC) is abnormal with a relatively high fat mass (FM) and low fat free mass (FFM). Abnormal BC is linked to poor prognosis and increased length of hospital stay; yet BC is not assessed in pediatric clinical practice. Instead, growth charts which lack sensitivity to detect changes in BC are used. Physical activity (PA) is the most important predictor of FFM and increased PA contributes to decreased FM. Decreased PA in childhood is associated with increased FM and decreased FFM which are linked to diabetes and cardiovascular disease in adulthood. Dual-energy X-ray Absorptiometry (DXA) is considered the reference method for measuring BC in the clinical setting but it is expensive and not suitable for routine use. Bioelectrical Impedance Analysis (BIA) on the other hand is relatively inexpensive and non-invasive but needs to be validated for use in patients with IF. Objectives: 1) validate BIA against DXA as a clinical tool for monitoring changes in BC in children with IF, 2) quantify PA levels using activity counts from accelerometers and 3) assess strength. Design: 1-18 years, with IF followed by the intestinal rehabilitation program at SickKids. All subjects receiving a DXA for routine clinical monitoring are eligible. BIA and muscle strength will be measured in clinic. Demographic data and IF related factors including height, weight, PN prescription, age, diagnosis, bowel length and length of time off PN for those who have achieved enteral autonomy will be obtained. DXA measurement will be done by Diagnostic Imaging at SickKids. Patients will be fitted with an accelerometer to be worn for 7 days. Statistics: Differences between sexes will be assessed by t test. Relationship between PA and BC, and BC and muscular strength will be assessed by linear regression analysis. Agreement between DXA and BIA will be assessed using a Bland-Altman test. Significance will be set at p\<0.05. Significance: This study has the potential to establish BIA as a convenient clinical tool to assess BC and provide a more accurate basis for nutritional and PA prescriptions to optimize long-term outcomes and quality of life in IF patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reduced strength is associated with abnormal body composition in children with a history of intestinal failure.
   Yanchis D, So S, Patterson C, Belza C, et al · · 2026 · PMID 41363022 · DOI 10.1002/jpn3.70307