Early Childhood Dietary Assessment Study

Official title

Enhancing the Accuracy of Self-Reported Dietary Intake in Young Children: Development of Two Proxy Reporting Protocols for Self-Reported Dietary Assessment

Overview

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.

Detailed description

This crossover, randomized controlled trial compares two proxy-reported dietary assessment protocols among caregivers with a child between the ages of 2 and 5 years. It also examines the dietary misreporting captured in each protocol and the accuracy of energy intake estimation from each methodology compared to objectively measured food intake. Caregivers with a child between the ages of 2 and 5 years and randomly assigned to one of two starting conditions: 1) traditional 24-hour dietary recall (24HR) or 2) Ecological momentary assessment (EMA)-assisted 24HR (EMA+24HR). Caregivers will complete the first assessment condition, and then, following a two-week washout period, will complete the other condition. In both conditions, caregivers will receive one meal and two snacks to provide to their child on three consecutive days. In addition to providing food, caregivers will identify a second caregiver (i.e., another parent, adult sibling, outside family member, or childcare worker) who will provide at least two eating occasions with study-provided foods over the three days. Including a caregiver outside of the primary proxy reporter will help assess the ability to accurately capture foods consumed away from the primary reporter, which has been identified as a challenge in dietary assessment among young children. The day after the child consumes study-provided foods, the caregiver will complete a 24HR via telephone with a trained research assistant following the United States Department of Agriculture five-step multiple pass method. After completing each dietary assessment condition, caregivers will complete an electronic survey that assesses the usability and acceptability of each proxy reporting protocol and dietary assessment condition.

The primary aims of this study are to:

1. Assess the feasibility, which will include the usability and acceptability, of the proxy reporting protocol for the 24HR and EMA+24HR. 2. Describe the dietary misreporting captured in the 24HR and EMA+24HR assessment strategies.

A secondary aim of the study will be to explore the accuracy, via determining agreement, of the 24 and EMA+24HR methods compared to objectively measured food intake, specifically in regard to energy intake.

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]
• 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.]

Secondary outcome measures (2)

• Accuracy of Energy Intake Estimation - EMA+24HR Condition [Time frame: Upon completion of EMA+24HR Condition]
• Accuracy of Energy Intake Estimation - Traditional Condition [Time frame: Upon completion of the Traditional 24HR condition]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Healthy Eating and Activity Lab, University of Tennessee — Knoxville

Publications

• Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415. PMID 18509902
• Reilly JJ, Montgomery C, Jackson D, MacRitchie J, Armstrong J. Energy intake by multiple pass 24 h recall and total energy expenditure: a comparison in a representative sample of 3-4-year-olds. Br J Nutr. 2001 Nov;86(5):601-5. doi: 10.1079/bjn2001449. PMID 11737958
• Wallace A, Kirkpatrick SI, Darlington G, Haines J. Accuracy of Parental Reporting of Preschoolers' Dietary Intake Using an Online Self-Administered 24-h Recall. Nutrients. 2018 Jul 29;10(8):987. doi: 10.3390/nu10080987. PMID 30060605
• Bornhorst C, Huybrechts I, Ahrens W, Eiben G, Michels N, Pala V, Molnar D, Russo P, Barba G, Bel-Serrat S, Moreno LA, Papoutsou S, Veidebaum T, Loit HM, Lissner L, Pigeot I; IDEFICS consortium. Prevalence and determinants of misreporting among European children in proxy-reported 24 h dietary recalls. Br J Nutr. 2013 Apr 14;109(7):1257-65. doi: 10.1017/S0007114512003194. Epub 2012 Aug 6. PMID 22863030
• Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318. PMID 10946797
• National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Callahan EA, editor. Approaches to Assessing Intake of Food and Dietary Supplements in Pregnant Women and Children 2 to 11 Years of Age: Proceedings of a Workshop Series. Washington (DC): National Academies Press (US); 2022 Jan 12. Available from http://www.ncbi.nlm.nih.gov/books/NBK5 PMID 35041355
• Ravelli MN, Schoeller DA. Traditional Self-Reported Dietary Instruments Are Prone to Inaccuracies and New Approaches Are Needed. Front Nutr. 2020 Jul 3;7:90. doi: 10.3389/fnut.2020.00090. eCollection 2020. PMID 32719809

Identifiers

NCT: NCT07227272 · UTK IRB-25-08725-XP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗