ILSI Energy Balance Study
A Novel Estimation of Energy Balance Through the Calibration of Consumer Devices in Free-living, Rural US Children
1 other identifier
observational
24
1 country
1
Brief Summary
The purpose of this study is to apply measurement error techniques on consumer devices to assess rate of energy storage \[ES\] and energy expenditure \[EE\], then estimate EI using the intake-balance technique. The goal of this study is to develop calibration models that will be able to be translated to other consumer devices with only minor modifications given common hardware (e.g. triaxial accelerometry), resulting in overall improved ability to assess energy balance and EI at a population level and positive health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
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 Start
First participant enrolled
January 13, 2018
CompletedFirst Submitted
Initial submission to the registry
April 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedFebruary 11, 2022
October 1, 2019
6 months
April 5, 2018
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Energy intake
Energy intake will be assessed subjectively via interviewer-administered dietary recalls. Three dietary recalls will occur on randomly selected non-consecutive days over each one-week treatment condition (including at least one weekend day) to minimize preparation that could bias recall by the participants. All interviews will be conducted over the telephone, will ask about all foods consumed over the previous 24 hours using a multi-pass approach, and energy intake will be calculated using the Nutrient Data System for Research software (NDSR Version 2014).
8 weeks
Secondary Outcomes (2)
Energy expenditure
2 weeks
Body composition
8 weeks
Eligibility Criteria
Participants will include 24 children or adults, ages 8-90.
You may qualify if:
- Healthy children and adults, aged 8-90.
- Able to be physically active.
You may not qualify if:
- History of restrained eating, eating disorders, bariatric surgery, or other significant medical diagnosis that could impact metabolism.
- Participants taking thyroid medications, beta blockers, or other stimulants (medications are known to affect metabolism).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
Biospecimen
Participants will provide a urine samples after which will be analyzed to calculate elimination rates of the doubly-labeled water isotopes from the body.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin Shook, PhD
Children's Mercy Kansas City
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2018
First Posted
October 29, 2019
Study Start
January 13, 2018
Primary Completion
July 5, 2018
Study Completion
July 5, 2018
Last Updated
February 11, 2022
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share