Recruiting

Dietary Assessment

Sponsor:

The University of Tennessee, Knoxville

Code:

NCT07227272

Conditions

Dietary Assessment

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

Interventions

Ecological Momentary Assessment

Traditional 24-hour dietary recall

Study Details

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.

Conditions

Dietary Assessment

Study ID

NCT07227272

Start date

Jul 15, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Apr 30, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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).

Interventions

Ecological 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.

Traditional 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.

Primary outcome measure

  • Usability - EMA+24HR Proxy-Reporting Protocol [ Time Frame: Upon completion of the EMA+24HR condition ]
  • Acceptability - EMA+24HR Proxy-Reporting Protocol [ Time Frame: Upon completion of the EMA+24HR condition ]
  • Usability of EMA Online Platform [ Time Frame: Upon completion of the EMA+24HR condition ]
  • Usability - Interface of EMA Platform [ Time Frame: Upon completion of the EMA+24HR condition ]
  • Acceptability - Online EMA Platform [ Time Frame: Upon completion of the EMA+24HR condition ]
  • Usability - Traditional 24HR Proxy-Reporting Protocol [ Time Frame: Upon completion of the traditional 24HR condition ]
  • Acceptability - Traditional 24HR Proxy Reporting Protocol [ Time Frame: Upon completion of the traditional 24HR condition ]
  • Dietary Misreporting - EMA+24HR Condition [ Time Frame: Upon completion of the EMA+24HR condition ]
  • Dietary Misreporting - Traditional 24HR Condition [ Time Frame: Upon completion of the traditional 24HR condition. ]

Central Contacts and Locations

Central contacts

Emilie Holloway, MS, RDN

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

Hollie Raynor, PhD, RD, LDN

865-974-9126hraynor@utk.edu

Locations

Healthy Eating and Activity Lab, University of Tennessee

Recruiting

Knoxville, Tennessee, United States, 37996

Contacts

Emilie Holloway, MS, RDN

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

Hollie Raynor, PhD, RD, LDN

865-974-9126hraynor@utk.edu

Principal Investigator:

Hollie Raynor, PhD, RD, LDN

More Information

Sponsor

The University of Tennessee, Knoxville

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Dietary Assessment
  • Assessment
  • Nutrition
  • Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Tennessee, Knoxville on 2026-06-08.