Early Childhood Dietary Assessment Study

NCT07227272 | Recruiting

• 1 other identifier: UTK IRB-25-08725-XP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Assess the usability and feasibility of each proxy-reporting protocol and dietary assessment methodology.
2. 2.Describe the dietary misreporting captured using each proxy-reporting protocol, and
3. 3.Explore the accuracy of energy intake estimation of the 24HR and EMA+24HR methods, compared to objectively measured food intake.
4. 4.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.
5. 5.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.
6. 6.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.

Conditions

Dietary Assessment

Keywords

Dietary Assessment; Assessment; Nutrition; Children

Outcome Measures

Primary Outcomes (9)

• 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.

  Upon completion of the EMA+24HR condition

• 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.

  Upon completion of the EMA+24HR condition

• 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.

  Upon completion of the EMA+24HR condition

• 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.

  Upon completion of the EMA+24HR condition

• 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.

  Upon completion of the EMA+24HR condition

• 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.

  Upon completion of the traditional 24HR condition

• 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.

  Upon completion of the traditional 24HR condition

• 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.

  Upon completion of the EMA+24HR condition

• 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.

  Upon completion of the traditional 24HR condition.

Secondary Outcomes (2)

• Accuracy of Energy Intake Estimation - EMA+24HR Condition

  Upon completion of EMA+24HR Condition

• Accuracy of Energy Intake Estimation - Traditional Condition

  Upon completion of the Traditional 24HR condition

Study Arms (2)

Traditional 24HR

ACTIVE COMPARATOR

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

EMA-Assisted 24HR

EXPERIMENTAL

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

Ecological Momentary Assessment OTHER

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.

EMA-Assisted 24HR

Traditional 24-hour dietary recall OTHER

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.

Traditional 24HR

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

Healthy Eating and Activity Lab, University of Tennessee

Knoxville, Tennessee, 37996, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 18509902 BACKGROUND

• 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.

  PMID: 11737958 BACKGROUND

• 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.

  PMID: 30060605 BACKGROUND

• 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.

  PMID: 22863030 BACKGROUND

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

  PMID: 10946797 BACKGROUND

• 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/

  PMID: 35041355 BACKGROUND

• 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.

  PMID: 32719809 BACKGROUND

MeSH Terms

Interventions

Ecological Momentary Assessment

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Emilie Holloway, MS, RDN

CONTACT

865-974-5894; ehollow5@vols.utk.edu

Hollie Raynor, PhD, RD, LDN

CONTACT

865-974-9126; hraynor@utk.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Associate Dean of Research & Operations

Model Details: Randomized crossover trial

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: November 12, 2025
• Study Start: July 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)