NCT01725347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

3.2 years

First QC Date

October 31, 2012

Last Update Submit

July 11, 2017

Conditions

Keywords

nutrition assessmentchildrenpreschooleating behaviorHead Startdigital technology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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).

    12 months

Study Arms (4)

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

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA/ARS Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples are to be collected.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Theresa A Nicklas, DrPH

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatric Nutrition

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 12, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2015

Study Completion

December 1, 2016

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations