Childhood ObesityNCT05296330
Energy Balance Teens: A Measurement Error Approach to Estimating Energy Balance in Free-Living Adolescents
An observational study of Childhood Obesity, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be healthy boys and girls.
Who may be able to join
- 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
Who cannot join
- -BMI percentile <5th or >99th
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
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.
Read the 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.
- Conditions
- Childhood Obesity
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess enrollment rates of the proposed protocol in adolescents and determine critical processes for the success of a future large-scale study
The investigators will assess enrollment rates (number enrolled divided by the number of total volunteers) on the protocol and study experience
Measured: Baseline
Assess participant feedback of the proposed protocol in adolescents and determine critical processes for the success of a future large-scale study
The investigators will assess participant feedback (tolerability using 1-10 Likert scales) on the protocol and study experience
Measured: Baseline
Determine the measurement error structure in an energy balance equation.
The measurement error of energy balance will be evaluated by Bayesian measurement-error models (MEM) as outlined in Ries et al. 2018.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start26 Mar 2022
- Primary completion11 Jan 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Shook, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296330
- Sponsor's protocol ID
- STUDY00002099
- Status last verified
- Dec 2023
- First submitted
- 9 Feb 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Balance Teens: A Measurement Error Approach to Estimating Energy Balance in Free-Living Adolescents
- ClinicalTrials.gov ID
- NCT05296330
- Acronym / sponsor ID
- STUDY00002099
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be healthy boys and girls.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -BMI percentile <5th or >99th
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.