Validation of a Digital Diet Method for Use With Preschoolers

Feeding Behaviors Clinical Trial

Official title:

Validation of a Digital Diet Method for Use With Preschoolers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725347
• Other study ID #: H-29112
• Secondary ID: R01CA142919-01A1
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: July 11, 2017
• Start date: February 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behaviors

Locations

Country	Name	City	State
United States	USDA/ARS Children's Nutrition Research Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The Bland-Altman method was used to measure the agreement between digital photography estimated weight and actual weight. This method uses a two step process that evaluates the accuracy (validity) of a "new" measurement technique compared to and existing "gold standard", which was the actual weights of foods.	12 months
Secondary	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).	The Same statistical analysis methods used for the Primary Outcome Measure will be applied. Additionally, the Bland-Altman technique will be used to assess the degree of agreement between the two methods.	12 months