ILSI Energy Balance Study

A Novel Estimation of Energy Balance Through the Calibration of Consumer Devices in Free-living, Rural US Children

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity

Detailed Description

There are four stages in the proposed project: 1) We will validate EE and ES (hereafter, Fitbit_EE and Fitbit_ES) from a consumer physical activity monitor (Fitbit Alta HR™) and body composition analyzer (Fitbit Aria™) with gold-standard measures of DLW for EE and DXA for ES during a 14-day baseline period; 2) We will estimate EI using the intake-balance method during the 14-day baseline period; 3) We will calibrate daily Fitbit_EE and Fitbit_ES from consumer devices using a Bayesian semi-parametric measurement error modeling approach to estimate energy balance; 4) We will reassess our validation and calibration models of consumer devices during a 14-day post-study assessment period to evaluate changes associated with growth and development with gold-standard measures of DLW for EE and DXA for ES.

Aims of the proposed study are to:

Specific Aim 1. Validate and calibrate consumer devices to estimate energy balance using gold-standard methods and a Bayesian semi-parametric approach. Hypothesis 1: We will be able to jointly model measurement error for both EE and ES to create a calibration model that reduces bias and improves accuracy of consumer devices of EE and ES.

Specific Aim 2. Estimate energy intake using the intake-balance technique using consumer monitors. Hypothesis 2:We will use calibrated EE and ES from consumer monitors to estimate EI using the intake-balance technique, with values being superior to self-reported EI.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will include 24 children or adults, ages 8-90.

Description

Inclusion Criteria:

• Healthy children and adults, aged 8-90.
• Able to be physically active.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure	Energy expenditure will be assessed using the doubly labelled water (DLW) technique over a two week period.	2 weeks
Body composition	Assessment of body composition, including fat mass, fat free mass, and visceral adipose tissue, will be completed using dual energy X-ray absorptiometry (DXA).	8 weeks

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: International Life Sciences Institute
• Investigators: Principal Investigator: Robin Shook, PhD, Children's Mercy Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2018
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Metabolism; Energy Balance
• Other Study ID Numbers: 17030190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No