NCT07227272 Early Childhood Dietary Assessment Study
| NCT ID | NCT07227272 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Tennessee, Knoxville |
| Condition | Dietary Assessment |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-15 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07227272 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 5 Years, studying Dietary Assessment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07227272 currently recruiting?
Yes, NCT07227272 is actively recruiting participants. Contact the research team at ehollow5@vols.utk.edu for enrollment information.
Where is the NCT07227272 trial being conducted?
This trial is being conducted at Knoxville, United States.
Who is sponsoring the NCT07227272 clinical trial?
NCT07227272 is sponsored by The University of Tennessee, Knoxville. The trial plans to enroll 40 participants.