Energy Balance Teens: A Measurement Error Approach to Estimating Energy Balance in Free-Living Adolescents

December 1, 2023 updated by: Robin Shook, Children's Mercy Hospital Kansas City
There is a critical need to develop an affordable, valid, and reliable techniques to assess free-living energy expenditure (EE), energy storage (ES), and energy intake (EI). The purpose of this project is to develop and evaluate statistical procedures to model, quantify and adjust for the measurement error of and consumer (e.g., Garmin) activity monitors and body composition scales to estimate EE and ES, and use the 'calibrated' values to estimate free-living EI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Dietary intake and physical activity are important lifestyle behaviors that have a profound role in the development of my many chronic diseases, including heart disease, diabetes, kidney disease, certain cancers, and overweight/obesity. It is clear that there are a multitude of physiological, environmental, and behavioral factors that influence obesity risk, but at the most basic level body weight is determined by the energy balance of energy intake (EI) and energy expenditure (EE). Standard assessment techniques of EI in population-based studies rely on individuals to self-report the foods they eat, but these estimates are typically 12-31% below expected values. This has led expert dieticians and nutritional epidemiologists to declare 'EI is inaccurately measured by self-report' and 'wholly unacceptable for scientific research.' Thus, there is a critical need to develop an affordable, valid, and reliable techniques to assess free-living EE, energy storage (ES), and EI. The investigator's long-term goal is to assess the components of energy balance to better inform obesity prevention and treatment. The short-term goal, and the purpose of this application, is to develop and evaluate statistical procedures to model, quantify and adjust for the measurement error of and consumer (e.g., Fitbit) activity monitors and body composition scales to estimate EE and ES, and use the 'calibrated' values to estimate free-living EI. The status quo as it relates to the use of non-gold standard devices is that there exists large variability compared to criterion measures that may produce erroneous estimates, particularly in mean EE, making their use at a population-level ill-advised. In contrast, the investigator's working hypothesis is that the error inherent in consumer devices can be quantified and adjusted for, allowing for the accurate assessment of EE and ES. The purpose of this project is to apply measurement error techniques to a pilot sample (N=24) of free-living adolescents to improve energy balance estimates. The investigators will use a consumer physical activity monitor (Garmin Vivofit 4), and a consumer body composition analyzer (Garmin Smartscale) to estimate daily EE and change in ES over two consecutive 14-day periods, separated by a 14-day washout period. The investigators will develop calibration models using simultaneously collected gold-standard techniques including doubly labeled water for EE and duel-energy x-ray absorptiometry for ES as references. The investigators will use the calibrated EE and ES to calculate EI using the intake-balance technique. Lastly, the investigators will evaluate the feasibility and acceptability of the protocols and methodology. At the completion of the proposed study, it is the investigators expectation that they will have generated important pilot data and assessed project feasibility in adolescents for a large-scale NIH R01 application. A fully powered study will improve the assessment of EE and ES in free-living conditions using research grade and consumer devices, allowing for the estimation of EI with greater accuracy than currently available techniques. This project will make significant advancements on the assessment of energy balance in free-living settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be healthy boys and girls.

Description

Inclusion Criteria:

  • All participants will need to have an in-home Wi-Fi network and access to a smartphone that can operate mobile applications to automatically sync with the Garmin devices
  • BMI percentile between 5th and 99th

Exclusion Criteria:

-BMI percentile <5th or >99th

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess enrollment rates of the proposed protocol in adolescents and determine critical processes for the success of a future large-scale study
Time Frame: Baseline
The investigators will assess enrollment rates (number enrolled divided by the number of total volunteers) on the protocol and study experience
Baseline
Assess participant feedback of the proposed protocol in adolescents and determine critical processes for the success of a future large-scale study
Time Frame: Baseline
The investigators will assess participant feedback (tolerability using 1-10 Likert scales) on the protocol and study experience
Baseline
Determine the measurement error structure in an energy balance equation.
Time Frame: Baseline
The measurement error of energy balance will be evaluated by Bayesian measurement-error models (MEM) as outlined in Ries et al. 2018.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002099

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings