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Dietary AssessmentECDASNCT07227272

Early Childhood Dietary Assessment Study

A study testing Ecological Momentary Assessment and Traditional 24-hour dietary recall in people with Dietary Assessment, run by The University of Tennessee, Knoxville at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this crossover randomized controlled trial is to develop a proxy reporting protocol for a traditional 24-hour dietary recall (24HR) and an ecological momentary assessment (EMA) assisted 24-HR for use among children between the ages of 2 and 5 years. The main aims are to: 1. Read more about this study

Who is it for?
Ages 2 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Dietary Assessment
What is being tested?
Ecological Momentary Assessment and Traditional 24-hour dietary recall
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Jul 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 2 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Adult caregiver ≥ 18 years old
  • Absence of food allergies or dietary restrictions for medical reasons (for the child)
  • Caregiver reports child likes at least 70% of the study-provided foods from the pre-defined list of food options
  • Caregiver has access to a smartphone device compatible with the EMA platform
  • Caregiver can identify a second adult caregiver with access to a smartphone device compatible with the EMA platform and willing to provide the child with study-provided foods for at least two eating occasions.

Who cannot join

  • Caregiver unwilling to feed study-provided foods to their child
  • Caregiver unwilling to take pre-and-post photos of child's eating occasions
  • Caregiver unwilling or unable to identify a second adult caregiver meeting the eligibility criteria
  • Caregiver and child reside in a separate household for > 2 days per week
  • Family resides >25 miles outside of the Knoxville, Tennessee, metropolitan area.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emilie Holloway, MS, RDN contact

865-974-5894

ehollow5@vols.utk.edu

Hollie Raynor, PhD, RD, LDN contact

865-974-9126 ext. 1

hraynor@utk.edu

United States1 site, 1 recruiting
  • Healthy Eating and Activity Lab, University of Tennessee

    Knoxville, Tennessee, 37996

    Emilie Holloway, MS, RDN, 865-974-5894, ehollow5@vols.utk.edu

    Hollie Raynor, PhD, RD, LDN, 865-974-9126 ext. 1, hraynor@utk.edu

    Recruiting

Other trials in United States

About this study

Official title: Enhancing the Accuracy of Self-Reported Dietary Intake in Young Children: Development of Two Proxy Reporting Protocols for Self-Reported Dietary Assessment

The goal of this crossover randomized controlled trial is to develop a proxy reporting protocol for a traditional 24-hour dietary recall (24HR) and an ecological momentary assessment (EMA) assisted 24-HR for use among children between the ages of 2 and 5 years. The main aims are to:

  1. Assess the usability and feasibility of each proxy-reporting protocol and dietary assessment methodology.
  2. Describe the dietary misreporting captured using each proxy-reporting protocol, and
  3. Explore the accuracy of energy intake estimation of the 24HR and EMA+24HR methods, compared to objectively measured food intake.
Read more

During the research study, participants will:

  1. Be provided with one meal and two snacks each day to provide to their child on three consecutive days. Foods can be offered to their child at times of their choosing, and leftovers will be placed back into reusable food storage containers to be picked up by research study staff. Uneaten foods will be weighed for an objective measure of intake.
  2. The day after study-provided foods are given to the child, the adult caregiver will complete a proxy-reported 24HR phone call with a trained research assistant.
  3. In the EMA+24HR condition, caregivers will be provided access to an online platform where they will upload pre- and post-photographs of all of their child's eating occasions across the three days that study-provided foods are eaten.
Read the detailed description

This crossover, randomized controlled trial compares two proxy-reported dietary assessment protocols among caregivers with a child between the ages of 2 and 5 years. It also examines the dietary misreporting captured in each protocol and the accuracy of energy intake estimation from each methodology compared to objectively measured food intake. Caregivers with a child between the ages of 2 and 5 years and randomly assigned to one of two starting conditions: 1) traditional 24-hour dietary recall (24HR) or 2) Ecological momentary assessment (EMA)-assisted 24HR (EMA+24HR). Caregivers will complete the first assessment condition, and then, following a two-week washout period, will complete the other condition. In both conditions, caregivers will receive one meal and two snacks to provide to their child on three consecutive days. In addition to providing food, caregivers will identify a second caregiver (i.e., another parent, adult sibling, outside family member, or childcare worker) who will provide at least two eating occasions with study-provided foods over the three days. Including a caregiver outside of the primary proxy reporter will help assess the ability to accurately capture foods consumed away from the primary reporter, which has been identified as a challenge in dietary assessment among young children. The day after the child consumes study-provided foods, the caregiver will complete a 24HR via telephone with a trained research assistant following the United States Department of Agriculture five-step multiple pass method. After completing each dietary assessment condition, caregivers will complete an electronic survey that assesses the usability and acceptability of each proxy reporting protocol and dietary assessment condition.

The primary aims of this study are to:

  1. Assess the feasibility, which will include the usability and acceptability, of the proxy reporting protocol for the 24HR and EMA+24HR.
  2. Describe the dietary misreporting captured in the 24HR and EMA+24HR assessment strategies.

A secondary aim of the study will be to explore the accuracy, via determining agreement, of the 24 and EMA+24HR methods compared to objectively measured food intake, specifically in regard to energy intake.

Being tested
Ecological Momentary Assessment, Traditional 24-hour dietary recall
Keywords
Dietary Assessment, Assessment, Nutrition, Children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ecological Momentary AssessmentOther

    The EMA platform will allow for the primary caregiver (or any other adult with whom the child eats foods with) to upload pre- and post-photographs of all eating occasions. The photographs will be time-stamped and will be used by trained research assistants during the 24HR to aid in collection of accurate information about what the child consumed. The research assistant will be trained on how to prompt the caregiver for inaccuracies in reporting as needed.

  • Traditional 24-hour dietary recallOther

    Participants will complete a traditional 24-hour dietary recall via telephone, following the USDA five-step multiple pass method. Participants will receive a standardized food amounts booklet (FAB) to help with quantifying portion sizes consumed.

Study groups in NCT07227272
Study groupRoleWhat they receive
Traditional 24HRActive comparatorCaregivers will be asked to provide study-provided foods to their child and complete a traditional 24-hour dietary recall using the USDA five-step multiple-pass method.
Receives: Other: Traditional 24-hour dietary recall
EMA-Assisted 24HRExperimentalIn the EMA+24HR condition, caregivers will receive study-provided foods for one meal and two snacks for three consecutive days. Caregivers will receive information on accessing an online EMA platform, and will be asked to upload pre- and post-photographs of the foods that their child eats over the three days. Additionally, any caregiver with whom the child consumes food outside of the primary proxy reporter will be trained by the primary caregiver and will be given access to upload photographs to the EMA site. The day following consumption of study-provided food, the caregiver will complete a 24HR using the USDA 5-step multiple-pass method by a trained research assistant. The research assistant will have access to all pre- and post-photographs and will prompt the caregiver for misreporting related to the photographs uploaded (i.e., time misreporting, omissions, intrusions, description, and amount misreporting).
Receives: Other: Ecological Momentary Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability - EMA+24HR Proxy-Reporting Protocol

    Usability of the proxy-reporting protocol for the EMA+24HR condition will be assessed using a self-reported questionnaire. Survey items will focus on adequacy of training and support received, experience communicating with other caregivers regarding what children consumed when they weren't with them, and experience completing the proxy-reported 24HR.

    Measured: Upon completion of the EMA+24HR condition

  2. Acceptability - EMA+24HR Proxy-Reporting Protocol

    Acceptability of the proxy-reporting protocol for the EMA+24HR condition will be assessed using a self-reported questionnaire. Survey items will focus on caregivers' satisfaction with training and support received, their experience communicating with other caregivers regarding what children consumed when they weren't with them, their experience completing the proxy-reported 24HR, and overall satisfaction.

    Measured: Upon completion of the EMA+24HR condition

  3. Usability of EMA Online Platform

    Usability of the online EMA platform will be assessed by comparing the number of pre- and post-photos collected to the self-reported eating occasions captured in the proxy-reported 24HR.

    Measured: Upon completion of the EMA+24HR condition

  4. Usability - Interface of EMA Platform

    The usability of the online EMA interface will be assessed using a self-report questionnaire by using the usefulness and interface quality subscales from the Post-Study System Usability Questionnaire.

    Measured: Upon completion of the EMA+24HR condition

  5. Acceptability - Online EMA Platform

    Four items from the Theoretical Framework of Acceptability (TFA) measure will be used to assess acceptability of the EMA platform, focusing on four constructs 1) affective attitudes, 2) burden, 3) self-efficacy, and 4) general acceptability.

    Measured: Upon completion of the EMA+24HR condition

  6. Usability - Traditional 24HR Proxy-Reporting Protocol

    Usability of proxy-reporting protocols for the traditional 24HR condition will be assessed using a self-reported questionnaire. Survey items will focus on adequacy of training and support received, experience communicating with other caregivers regarding what children consumed when they weren't with them, and experience completing the proxy-reported 24HR.

    Measured: Upon completion of the traditional 24HR condition

  7. Acceptability - Traditional 24HR Proxy Reporting Protocol

    Acceptability of the proxy-reporting protocol for the traditional 24HR condition will be assessed using a self-reported questionnaire. Survey items will focus on caregivers' satisfaction with training and support received, their experience communicating with other caregivers regarding what children consumed when they weren't with them, their experience completing the proxy-reported 24HR, and overall satisfaction.

    Measured: Upon completion of the traditional 24HR condition

  8. Dietary Misreporting - EMA+24HR Condition

    Frequency of dietary misreporting (i.e., time-misreporting, omissions, intrusions, description and amount misreporting) will be assessed in the EMA+24HR by comparison of self-reported dietary assessment to photos uploaded to the EMA platform.

    Measured: Upon completion of the EMA+24HR condition

  9. Dietary Misreporting - Traditional 24HR Condition

    Frequency of omissions will be assessed in the traditional 24HR condition using pre-post food weights to proxy-reported intake from the primary caregiver.

    Measured: Upon completion of the traditional 24HR condition.

Secondary outcomes (2)
  1. Accuracy of Energy Intake Estimation - EMA+24HR Condition

    The accuracy of the EMA+24HR condition will be assessed by comparing self-reported estimation of study-provided foods obtained from proxy-reporters with objectively measured food intake (pre-post food weights).

    Measured: Upon completion of EMA+24HR Condition

  2. Accuracy of Energy Intake Estimation - Traditional Condition

    The accuracy of the traditional condition will be assessed by comparing self-reported estimation of study-provided foods obtained from proxy-reporters with objectively measured food intake (pre-post food weights).

    Measured: Upon completion of the Traditional 24HR condition

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start15 Jul 2025
  3. Primary completion30 Apr 2026
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized crossover trial
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227272
Sponsor's protocol ID
UTK IRB-25-08725-XP
Acronym
ECDAS
Status last verified
Jun 2026
First submitted
30 Jun 2025
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.

    PubMed 18509902
  • Reilly JJ, Montgomery C, Jackson D, MacRitchie J, Armstrong J. Energy intake by multiple pass 24 h recall and total energy expenditure: a comparison in a representative sample of 3-4-year-olds. Br J Nutr. 2001 Nov;86(5):601-5. doi: 10.1079/bjn2001449.

    PubMed 11737958
  • Wallace A, Kirkpatrick SI, Darlington G, Haines J. Accuracy of Parental Reporting of Preschoolers' Dietary Intake Using an Online Self-Administered 24-h Recall. Nutrients. 2018 Jul 29;10(8):987. doi: 10.3390/nu10080987.

    PubMed 30060605
  • Bornhorst C, Huybrechts I, Ahrens W, Eiben G, Michels N, Pala V, Molnar D, Russo P, Barba G, Bel-Serrat S, Moreno LA, Papoutsou S, Veidebaum T, Loit HM, Lissner L, Pigeot I; IDEFICS consortium. Prevalence and determinants of misreporting among European children in proxy-reported 24 h dietary recalls. Br J Nutr. 2013 Apr 14;109(7):1257-65. doi: 10.1017/S0007114512003194. Epub 2012 Aug 6.

    PubMed 22863030
  • Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318.

    PubMed 10946797
  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Callahan EA, editor. Approaches to Assessing Intake of Food and Dietary Supplements in Pregnant Women and Children 2 to 11 Years of Age: Proceedings of a Workshop Series. Washington (DC): National Academies Press (US); 2022 Jan 12. Available from http://www.ncbi.nlm.nih.gov/books/NBK576562/

    PubMed 35041355
  • Ravelli MN, Schoeller DA. Traditional Self-Reported Dietary Instruments Are Prone to Inaccuracies and New Approaches Are Needed. Front Nutr. 2020 Jul 3;7:90. doi: 10.3389/fnut.2020.00090. eCollection 2020.

    PubMed 32719809

Questions about this trial

What is this clinical trial studying?

A study testing Ecological Momentary Assessment and Traditional 24-hour dietary recall in people with Dietary Assessment, run by The University of Tennessee, Knoxville 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie Holloway, MS, RDN (865-974-5894, ehollow5@vols.utk.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability - EMA+24HR Proxy-Reporting Protocol (time frame: Upon completion of the EMA+24HR condition). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07227272, which also lists 7 linked publications.

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 8 Jun 2026.

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