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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
6 weeks
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)
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feedback on recall methods
Time Frame: 2 or 6 weeks
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.
2 or 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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