CClinicalTrials.gg
RecruitingNCT07227272ECDASUpdated Jun 8, 2026

Early Childhood Dietary Assessment Study

An interventional study of Ecological Momentary Assessment and Traditional 24-hour dietary recall in Dietary Assessment, sponsored by The University of Tennessee, Knoxville. Recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by The University of Tennessee, Knoxville · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Dietary Assessment

Keywords

  • Dietary Assessment
  • Assessment
  • Nutrition
  • Children
03

In context

Lead sponsor

The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Traditional 24HR

    Caregivers 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.

    Other: Traditional 24-hour dietary recall

  • Experimental
    EMA-Assisted 24HR

    In 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).

    Other: Ecological Momentary Assessment

Interventions

  • OtherEcological Momentary Assessment

    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.

  • OtherTraditional 24-hour dietary recall

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Upon completion of the traditional 24HR condition.

Secondary outcomes

  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).

    Time frame: 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).

    Time frame: Upon completion of the Traditional 24HR condition

07

Study locations

1 of 1 sites recruiting
  • Healthy Eating and Activity Lab, University of Tennessee
    Knoxville, Tennessee 37996, United States
    • Emilie Holloway, MS, RDN · Contact · ehollow5@vols.utk.edu · 865-974-5894
    • Hollie Raynor, PhD, RD, LDN · Contact · hraynor@utk.edu · 865-974-9126
    • Hollie Raynor, PhD, RD, LDN · Principal investigator
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07227272
Lead sponsor
The University of Tennessee, Knoxville
Responsible party
Hollie Raynor (Executive Associate Dean of Research & Operations, The University of Tennessee, Knoxville) — Principal investigator
First posted
Nov 12, 2025
Start date
Jul 15, 2025
Primary completion
Apr 30, 2026
Completion
Dec 2026 (estimated)
Last update
Jun 8, 2026

Study contacts

Emilie Holloway, MS, RDN
Contact
ehollow5@vols.utk.edu
865-974-5894
Hollie Raynor, PhD, RD, LDN
Contact
hraynor@utk.edu
865-974-9126 ext. 1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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