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Validation of a Digital Diet Method for Use With Preschoolers

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ClinicalTrials.gov Identifier: NCT01725347
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : July 12, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Theresa A Nicklas, Baylor College of Medicine

Tracking Information
First Submitted Date October 31, 2012
First Posted Date November 12, 2012
Last Update Posted Date July 12, 2017
Actual Study Start Date February 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2012)
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 ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 8, 2012)
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 ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a Digital Diet Method for Use With Preschoolers
Official Title Validation of a Digital Diet Method for Use With Preschoolers
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine samples are to be collected.
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).
Condition Feeding Behaviors
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2012)
94
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01725347
Other Study ID Numbers H-29112
R01CA142919-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Theresa A Nicklas, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Theresa A Nicklas, DrPH Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date July 2017