Feeding BehaviorsNCT01725347
Validation of a Digital Diet Method for Use With Preschoolers
An observational study of Feeding Behaviors, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behaviors
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 3-5 years old
- Attends Head Start
- African-American
- Hispanic American
- Can physically complete the tasks required in the proposed research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA/ARS Children's Nutrition Research Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Feeding Behaviors
- Keywords
- nutrition assessment, children, preschool, eating behavior, Head Start, digital technology
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Theresa A Nicklas, Baylor College of Medicine
- Investigators
- Theresa A Nicklas, DrPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725347
- Sponsor's protocol ID
- H-29112
- Other IDs
- R01CA142919-01A1
- Status last verified
- Jul 2017
- First submitted
- 31 Oct 2012
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22727939Nicklas 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.
PubMed 28758370Nicklas 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.
PubMed 28637631
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Digital Diet Method for Use With Preschoolers
- ClinicalTrials.gov ID
- NCT01725347
- Acronym / sponsor ID
- H-29112
- Conditions
- Feeding Behaviors
- Keywords
- nutrition assessment, children, preschool, eating behavior, Head Start, digital technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Feb 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (5 listed)
- 3-5 years old
- Attends Head Start
- African-American
- Hispanic American
- Can physically complete the tasks required in the proposed research
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Results publication: PubMed 22727939Nicklas 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.
- Derived from this study: PubMed 28758370Nicklas 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.
- Derived from this study: PubMed 28637631Nicklas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa A Nicklas, DrPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Behaviors, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01725347, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.