Physical ActivityNCT04142281
ILSI Energy Balance Study
An observational study of Physical Activity, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2018to 5 Jul 2018
- 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 8 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will include 24 children or adults, ages 8-90.
Who may be able to join
- Healthy children and adults, aged 8-90.
- Able to be physically active.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Keywords
- Energy Balance, Metabolism
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (2)
Energy expenditure
Energy expenditure will be assessed using the doubly labelled water (DLW) technique over a two week period.
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start13 Jan 2018
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- International Life Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Robin Shook, PhD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142281
- Sponsor's protocol ID
- 17030190
- Status last verified
- Oct 2019
- First submitted
- 5 Apr 2018
- Last updated
- 11 Feb 2022
- 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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Estimation of Energy Balance Through the Calibration of Consumer Devices in Free-living, Rural US Children
- ClinicalTrials.gov ID
- NCT04142281
- Acronym / sponsor ID
- 17030190
- Conditions
- Physical Activity
- Keywords
- Energy Balance, Metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- International Life Sciences Institute
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 29 Oct 2019 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will include 24 children or adults, ages 8-90.
Key inclusion criteria (2 listed)
- Healthy children and adults, aged 8-90.
- Able to be physically active.
Key exclusion criteria (2 listed)
- 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).
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
Energy intake
Time frame: 8 weeks
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).
2 secondary outcomes
Energy expenditure
Time frame: 2 weeks
Body composition
Time frame: 8 weeks
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 11 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Robin Shook, PhD principal investigator
Children's Mercy Kansas City
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 Physical Activity, 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 2 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 11 Feb 2022. 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?
Energy intake (time frame: 8 weeks). 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 11 Feb 2022.