NCT07227272 · The University of Tennessee, Knoxville
Early Childhood Dietary Assessment Study
(ECDAS)
What this study is about
The goal of this crossover randomly assigned 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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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 measures
Usability - EMA+24HR Proxy-Reporting Protocol
Time frame: Upon completion of the EMA+24HR condition
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.
Acceptability - EMA+24HR Proxy-Reporting Protocol
Time frame: Upon completion of the EMA+24HR condition
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.
Usability of EMA Online Platform
Time frame: Upon completion of the EMA+24HR condition
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.
Usability - Interface of EMA Platform
Time frame: Upon completion of the EMA+24HR condition
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.
Acceptability - Online EMA Platform
Time frame: Upon completion of the EMA+24HR condition
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.
Usability - Traditional 24HR Proxy-Reporting Protocol
Time frame: Upon completion of the traditional 24HR condition
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.
Acceptability - Traditional 24HR Proxy Reporting Protocol
Time frame: Upon completion of the traditional 24HR condition
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.
Dietary Misreporting - EMA+24HR Condition
Time frame: Upon completion of the 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.
Dietary Misreporting - Traditional 24HR Condition
Time frame: Upon 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Knoxville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations