Early Childhood Dietary Assessment Study
ConditionDietary Assessment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorThe University of Tennessee, Knoxville
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Ecological Momentary Assessment
Other interventionThe 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 interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Traditional 24HRActive comparator 1 intervention
Group B: EMA-Assisted 24HRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Usability - EMA+24HR Proxy-Reporting Protocol
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.
Time frame
Upon completion of the EMA+24HR condition2
Acceptability - EMA+24HR Proxy-Reporting Protocol
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.
Time frame
Upon completion of the EMA+24HR condition3
Usability of EMA Online Platform
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.
Time frame
Upon completion of the EMA+24HR condition4
Usability - Interface of EMA Platform
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.
Time frame
Upon completion of the EMA+24HR conditionSecondary outcomes
1
Accuracy of Energy Intake Estimation - EMA+24HR Condition
The 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).
Time frame
Upon completion of EMA+24HR Condition2
Accuracy of Energy Intake Estimation - Traditional Condition
The 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).
Time frame
Upon completion of the Traditional 24HR conditionSponsors and contacts
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Source ClinicalTrials.gov