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Early Childhood Dietary Assessment Study

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07227272
Acronym
ECDAS
Enrollment
40
Registered
2025-11-12
Start date
2025-07-15
Completion date
2026-07-31
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Assessment

Keywords

Dietary Assessment, Assessment, Nutrition, Children

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. 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.

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.

Interventions

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.

Sponsors

The University of Tennessee, Knoxville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Randomized crossover trial

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Dietary Misreporting - Traditional 24HR ConditionUpon completion of the 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.
Acceptability - Traditional 24HR Proxy Reporting ProtocolUpon completion of the traditional 24HR conditionAcceptability 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.
Dietary Misreporting - EMA+24HR ConditionUpon completion of the EMA+24HR conditionFrequency 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.
Usability - Traditional 24HR Proxy-Reporting ProtocolUpon completion of the traditional 24HR conditionUsability 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.
Usability - EMA+24HR Proxy-Reporting ProtocolUpon completion of the EMA+24HR conditionUsability 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.
Acceptability - EMA+24HR Proxy-Reporting ProtocolUpon completion of the EMA+24HR conditionAcceptability 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.
Usability of EMA Online PlatformUpon completion of the EMA+24HR conditionUsability 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.
Usability - Interface of EMA PlatformUpon completion of the EMA+24HR conditionThe 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.
Acceptability - Online EMA PlatformUpon completion of the EMA+24HR conditionFour 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.

Secondary

MeasureTime frameDescription
Accuracy of Energy Intake Estimation - Traditional ConditionUpon completion of the Traditional 24HR conditionThe 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).
Accuracy of Energy Intake Estimation - EMA+24HR ConditionUpon completion of EMA+24HR ConditionThe 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).

Countries

United States

Contacts

Primary ContactEmilie Holloway, MS, RDN
ehollow5@vols.utk.edu865-974-5894
Backup ContactHollie Raynor, PhD, RD, LDN
hraynor@utk.edu865-974-9126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026