Diet Intake AssessmentDIETTNCT02818933
Diet Intake Estimation of Tweens and Teens: The DIETT Study
An observational study of Diet Intake Assessment, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Intake Assessment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2015
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy male and female adolescents, ages 12-17 years.
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Intake Assessment
- Keywords
- 24-hour diet recall, Adolescents, Web-based diet recall
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 |
|---|---|---|
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reporting decay
Change (decline) in self-reported energy intake and number of foods consumed over the six-week study duration (Aim 2)
Measured: 6 weeks
Method preference
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)
Measured: 2 weeks
Secondary outcomes (1)
Feedback on recall methods
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.
Measured: 2 or 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet Intake AssessmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Kalkwarf, PhD, Study director, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818933
- Sponsor's protocol ID
- CIN_"HughesDIETT"_001
- Acronym
- DIETT
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not at this time.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Automated Self-Administered 24-hour Recall Compared to an Interviewer-administered 24-hour Diet Recall in Adolescents
- ClinicalTrials.gov ID
- NCT02818933
- Acronym / sponsor ID
- DIETT / CIN_"HughesDIETT"_001
- Conditions
- Diet Intake Assessment
- Keywords
- 24-hour diet recall, Adolescents, Web-based diet recall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2016 (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 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.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy male and female adolescents, ages 12-17 years.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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
Reporting decay
Time frame: 6 weeks
Change (decline) in self-reported energy intake and number of foods consumed over the six-week study duration (Aim 2)
Method preference
Time frame: 2 weeks
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)
1 secondary outcome
Feedback on recall methods
Time frame: 2 or 6 weeks
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 30 Jun 2016.
- Individual participant dataSharing planned: No. Not at this time.
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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.
Heidi Kalkwarf, PhD study director
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Intake Assessment, run by Children's Hospital Medical Center, Cincinnati.
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 1 inclusion and 6 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Reporting decay (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2016.