Validation StudyNCT00978406
National Cancer Institute Food Study
An observational study of Validation Study and Diet Surveys, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Information about Americans food choices and opinions helps researchers and law makers to develop policies and programs to promote health. For this reason, it is important to be able to collect good quality information about how people think about food. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Validation Study, Diet Surveys, Nutritional Assessment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2009to 26 Feb 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers living in Maryland@@@
- Eligibility Criteria
- Individuals between the ages of 20 and 70, recruited from a database of volunteers who wish to participate in research studies.
- Volunteers must have high-speed Internet access.
- Individuals who have previously been involved in a research study will be excluded.
- Subjects will be accrued from a variety of racial and ethnic groups and of varying educational achievement, though these characteristics will not be used to assess eligibility.
- All subjects will provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Cancer Institute (NCI) Food Study
Information about Americans food choices and opinions helps researchers and law makers to develop policies and programs to promote health. For this reason, it is important to be able to collect good quality information about how people think about food. This project will compare different ways of collecting information about food from adults.
Read the detailed description
Objectives:
-To compare different ways of collecting information about food choices and opinions from adults.
Eligibility:
- Individuals between the ages of 20 and 70, recruited from a database of volunteers who wish to participate in research studies.
- Volunteers must have high-speed Internet access.
- Individuals who have previously been involved in a research study will be excluded.
Design:
-Participants will come to a research study center for three consecutive meals (approximately 45 minutes per meal). On the following day, participants will return to the study center for an interview about their food choices and opinions (approximately 45 minutes).
- Keywords
- Dietary Assessment Methods, Measurement of Diet, 24-Hour Diet Recall, Validation, Feeding Study
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 |
|---|---|---|
| Healthy volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of truth and reported dietary intake
Measured exact intake of foods will be compared to reported intake by the participant. Two different reporting systems will be compared with truth.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study start26 Aug 2009
- Primary completion31 Jul 2013
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Validation StudyStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy A. Potischman, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978406
- Sponsor's protocol ID
- 999909209
- Other IDs
- 09-C-N209
- Status last verified
- Mar 2020
- First submitted
- 15 Sep 2009
- Last updated
- 3 Mar 2020
- Results posted
- No
Publications
Kirkpatrick SI, Potischman N, Dodd KW, Douglass D, Zimmerman TP, Kahle LL, Thompson FE, George SM, Subar AF. The Use of Digital Images in 24-Hour Recalls May Lead to Less Misestimation of Portion Size Compared with Traditional Interviewer-Administered Recalls. J Nutr. 2016 Dec;146(12):2567-2573. doi: 10.3945/jn.116.237271. Epub 2016 Nov 2.
PubMed 27807039Kirkpatrick SI, Subar AF, Douglass D, Zimmerman TP, Thompson FE, Kahle LL, George SM, Dodd KW, Potischman N. Performance of the Automated Self-Administered 24-hour Recall relative to a measure of true intakes and to an interviewer-administered 24-h recall. Am J Clin Nutr. 2014 Jul;100(1):233-40. doi: 10.3945/ajcn.114.083238. Epub 2014 Apr 30.
PubMed 24787491
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cancer Institute (NCI) Food Study
- ClinicalTrials.gov ID
- NCT00978406
- Acronym / sponsor ID
- 999909209
- Keywords
- Dietary Assessment Methods, Measurement of Diet, 24-Hour Diet Recall, Validation, Feeding Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Aug 2009 (actual)
- Primary completion
- 31 Jul 2013 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 16 Sep 2009 (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.
Information about Americans food choices and opinions helps researchers and law makers to develop policies and programs to promote health. For this reason, it is important to be able to collect good quality information about how people think about food. This project will compare different ways of collecting information about food from adults.
Detailed description
Objectives:
-To compare different ways of collecting information about food choices and opinions from adults.
Eligibility:
- Individuals between the ages of 20 and 70, recruited from a database of volunteers who wish to participate in research studies.
- Volunteers must have high-speed Internet access.
- Individuals who have previously been involved in a research study will be excluded.
Design:
-Participants will come to a research study center for three consecutive meals (approximately 45 minutes per meal). On the following day, participants will return to the study center for an interview about their food choices and opinions (approximately 45 minutes).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers living in Maryland@@@
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
Agreement of truth and reported dietary intake
Time frame: 2 days
Measured exact intake of foods will be compared to reported intake by the participant. Two different reporting systems will be compared with truth.
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 3 Mar 2020.
- Derived from this study: PubMed 27807039Kirkpatrick SI, Potischman N, Dodd KW, Douglass D, Zimmerman TP, Kahle LL, Thompson FE, George SM, Subar AF. The Use of Digital Images in 24-Hour Recalls May Lead to Less Misestimation of Portion Size Compared with Traditional Interviewer-Administered Recalls. J Nutr. 2016 Dec;146(12):2567-2573. doi: 10.3945/jn.116.237271. Epub 2016 Nov 2.
- Derived from this study: PubMed 24787491Kirkpatrick SI, Subar AF, Douglass D, Zimmerman TP, Thompson FE, Kahle LL, George SM, Dodd KW, Potischman N. Performance of the Automated Self-Administered 24-hour Recall relative to a measure of true intakes and to an interviewer-administered 24-h recall. Am J Clin Nutr. 2014 Jul;100(1):233-40. doi: 10.3945/ajcn.114.083238. Epub 2014 Apr 30.
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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.
Nancy A. Potischman, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Validation Study and Diet Surveys, run by National Cancer Institute (NCI) 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?
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 3 Mar 2020. 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?
Agreement of truth and reported dietary intake (time frame: 2 days). 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 NCT00978406, which also lists 2 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 3 Mar 2020.