- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818933
Diet Intake Estimation of Tweens and Teens: The DIETT Study (DIETT)
June 28, 2016 updated by: Children's Hospital Medical Center, Cincinnati
A Randomized Study of the Automated Self-Administered 24-hour Recall Compared to an Interviewer-administered 24-hour Diet Recall in Adolescents
The purpose of this pilot study is to assess the quality of self-report data obtained using the Automated Self Administered 24-Hour Recall (ASA24-Kids-2014) relative to an interviewer administered 24-hour recall in a sample of adolescents ages 12-17 years, to determine their method preference, and to assess issues related to each method.
Study Overview
Status
Completed
Conditions
Detailed Description
Self-reported dietary intake currently provides the best approach to quantify foods and nutrients for many nutrition research studies.
The interviewer administered 24-hour diet recall is generally considered the best available method; however, it is limited by a high degree of participant burden and cost.
A web-based, automated, self-administered 24-hour recall (ASA24-Kids-2014) was recently designed by researchers at the National Cancer Institute (NCI) to mimic the interviewer administered 24-hour recall approach to collecting high quality dietary intake data in children and adolescents while minimizing time and cost.
Although the ASA24-Kids-2014 is a potentially useful and cost-effective tool for collecting dietary data for research studies in children and adolescents, it has not been validated for use in pediatric populations.
A total of 30 adolescents will be recruited to achieve the study aims.
For Aim 1, 10 participants will complete one diet recall using ASA24-Kids-2014 and one interviewer administered 24-hour recall.
Their feedback on both methods and preference will be assessed.
For Aim 2, 20 participants will be randomly assigned to complete six (one per week) web-based or interviewer administered 24-hour recalls.
Data from Aim 2 will be analyzed to determine whether the reporting quality decays over time for each method.
In addition, feedback from participants in both aims will be collected on specific factors related to the recall methods such as ease of use, technical challenges, flexibility, duration, and database completeness.
Results obtained from this pilot study could provide critical information to design a larger method comparison study to rigorously assess the performance of the ASA24-Kids web-based diet recall.
Study Type
Observational
Enrollment (Actual)
30
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy male and female adolescents, ages 12-17 years.
Description
Inclusion Criteria:
- Adolescents at least 12 years old and no greater than 17 years old who have access to a phone and a desktop or laptop computer.
Exclusion Criteria:
- Persons having prior experience completing food recalls, either for a research study, or for personal use
- persons having prior experience with mobile food apps, either for research or for personal use
- persons following a special diet
- persons having a mental, physical, or visual limitation that would hinder their ability to use a computer or recall from memory
- Non-English speakers are excluded because using an interpreter could increase the length of time it takes to complete a dietary food recall thus, possibly skewing the data.
- those with self-reported body mass index (BMI) less than the 5th or greater than the 85th percentile (as determined during telephone screen)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Aim 1
This group follows a crossover design where adolescents 12-17 years old (n=10) complete a diet recall using one of the two methods (interviewer-administered vs web-based), and then does another diet recall using the other method about a week later.
Participants are randomly assigned to the order in which they complete each method of diet recall.
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Aim 2, interviewer-administered recall
This group of adolescents 12-17 years old (n=10) completes an interviewer-administered diet recall once a week for 6 weeks.
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Aim 2, web-based recall
This group of adolescents 12-17 years old (n=10) completes a web-based self-administered diet recall once a week for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reporting decay
Time Frame: 6 weeks
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Change (decline) in self-reported energy intake and number of foods consumed over the six-week study duration (Aim 2)
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6 weeks
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Method preference
Time Frame: 2 weeks
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Participants identify which diet recall method - interviewer-administered or web-based - they prefer overall, and on specific factors, via a qualitative feedback survey at the end of their study involvement (Aim 1)
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feedback on recall methods
Time Frame: 2 or 6 weeks
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Participants in both study aims answer questions about different aspects of using each recall method (Aim 1) or on using their assigned method (Aim 2), such as ease of use, technical challenges, flexibility, duration, and database completeness.
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2 or 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Heidi Kalkwarf, PhD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 28, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 30, 2016
Study Record Updates
Last Update Posted (Estimate)
June 30, 2016
Last Update Submitted That Met QC Criteria
June 28, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CIN_"HughesDIETT"_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Not at this time.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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