Clinical trial NCT01725347: Validation of a Digital Diet Method for Use With Preschoolers
Official title: Validation of a Digital Diet Method for Use With Preschoolers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding Behaviors
Keywords: nutrition assessment
children
preschool
eating behavior
Head Start
digital technology
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2012-11-12
Enrollment: 94
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: With an anticipated attrition rate of 15%, 62 children will be recruited, resulting in a sample size of 54 after attrition (14 HA boys; 14 HA girls; 13 AA boys; 13 AA girls).

Brief summary: The Validation of a Digital Diet Method project is very innovative because it links three methods to address the gap in measuring food intake of HS preschool children. Data collection is based on EMA theory; participant burden is low, and the Food Image App decreases participant and staff burden even further. Data management and analysis are semi-automated and relies on advanced computer algorithms. A strength of this approach is its semi-automation, which allows us to leverage the strengths of human operators and computer automation.

Detailed description: The goal of the proposed research is to modify the Remote Food Photography Method (RFPM) for use with preschoolers. Primary caregivers (the majority will be mothers) and HS assistants will use a Smartphone to capture 24-hour images of HS children's food selection and plate waste. The RFPM, Ecological Momentary Assessment (EMA). and the Food Photography Application© will be used to estimate the energy and nutrient intake of preschoolers. The accuracy of the RFPM will be examined by determining the energy and nutrient intake (collectively referred to as food intake \[FI\]) to established methods: 1) actual gram (g) weights of laboratory-based test meals and 2) doubly labeled water (DLW) in a natural environment.

Eligibility criteria: Inclusion Criteria:

* 3-5 years old
* Attends Head Start
* African-American
* Hispanic American
* Can physically complete the tasks required in the proposed research

Exclusion Criteria:

* Younger than 3 years old
* Older than 5 years old
* Does not attend Head Start
* Race/Ethnicity other than African-American or Hispanic-American
* Cannot physically complete the tasks required in the proposed research

Primary outcomes:
measure: This experiment will compare energy intake (EI) calculated using the test method (Remote Food Photography Method or RFPM) against energy intake calculated using weight measures (actual weighing of all food/beverages consumed).
timeFrame: 12 months
Secondary outcomes:
measure: This experiment will compare energy intake (EI) calculated using the test method (Remote Food Photography Method or RFPM) against energy expenditure using the Doubly Labeled Water method (DLW).
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: USDA/ARS Children's Nutrition Research Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Theresa A Nicklas, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicklas TA, O'Neil CE, Stuff J, Goodell LS, Liu Y, Martin CK. Validity and feasibility of a digital diet estimation method for use with preschool children: a pilot study. J Nutr Educ Behav. 2012 Nov-Dec;44(6):618-23. doi: 10.1016/j.jneb.2011.12.001. Epub 2012 Jun 23.
citation: Nicklas T, Saab R, Islam NG, Wong W, Butte N, Schulin R, Liu Y, Apolzan JW, Myers CA, Martin CK. Validity of the Remote Food Photography Method Against Doubly Labeled Water Among Minority Preschoolers. Obesity (Silver Spring). 2017 Sep;25(9):1633-1638. doi: 10.1002/oby.21931. Epub 2017 Jul 31.
citation: Nicklas T, Islam NG, Saab R, Schulin R, Liu Y, Butte NF, Apolzan JW, Myers CA, Martin CK. Validity of a Digital Diet Estimation Method for Use with Preschool Children. J Acad Nutr Diet. 2018 Feb;118(2):252-260. doi: 10.1016/j.jand.2017.05.005. Epub 2017 Jun 19.