Early Childhood Dietary Assessment Study

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
The University of Tennessee, Knoxville
Study ID
NCT07227272
Status
Recruiting
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Conditions

  • Dietary Assessment

Eligibility Criteria

Sex
ALL
Age
2 Years - 5 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.
  • 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).

Primary Outcome Measure

Usability - EMA+24HR Proxy-Reporting Protocol [ Time Frame: Upon completion of the EMA+24HR condition ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Healthy Eating and Activity Lab, University of TennesseeKnoxvilleTennessee37996
Emilie Holloway, MS, RDN
[email protected]
865-974-5894
Hollie Raynor, PhD, RD, LDN
[email protected]
865-974-9126
Hollie Raynor, PhD, RD, LDN (PRINCIPAL_INVESTIGATOR)

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By research site
Healthy Eating and Activity Lab, University of Tennessee· Knoxville, TN

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