Validation of a Digital Diet Method for Use With Preschoolers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Theresa A Nicklas, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01725347
First received: October 31, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition
Feeding Behaviors

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Validation of a Digital Diet Method for Use With Preschoolers

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Urine samples are to be collected.


Estimated Enrollment: 94
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
African American Girls
-25% of sample is African American Girls
African American Boys
-25% of sample is African American Boys
Hispanic American Girls
-25% of sample is Hispanic American Girls
Hispanic American Boys
-25% of sample is Hispanic American Boys

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

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725347

Locations
United States, Texas
USDA/ARS Children's Nutrition Research Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Theresa A Nicklas, DrPH Baylor College of Medicine
  More Information

Publications:
Responsible Party: Theresa A Nicklas, Professor of Pediatric Nutrition, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01725347     History of Changes
Other Study ID Numbers: H-29112, R01CA142919-01A1
Study First Received: October 31, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
nutrition assessment
children
preschool
eating behavior
Head Start
digital technology

ClinicalTrials.gov processed this record on July 22, 2014