DietNCT00339677
Recontacting Participants in the Observing Protein and Energy Nutrition (OPEN) Study: Re-OPEN
An observational study of Diet and Diet Surveys, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will evaluate the structure of error in self-reporting instruments on diet, in following up the Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and 2000. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Diet, Diet Surveys
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2003to 24 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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers.
Who may be able to join
- As this is a follow-up to a previous study with NCI SSIRB approval, there will be no recruitment of new participants. In the original OPEN study, we recruited a sample of men and women between 40-69 years of age. This age group represents those most likely to be recruited for large-scale epidemiological studies of diet and cancer. It is in this same group that we seek to assess measurement error problems for other dietary assessment instruments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Recontacting Participants in the Observing Protein and Energy Nutrition Study: ReOPEN
This study will evaluate the structure of error in self-reporting instruments on diet, in following up the Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and 2000. The OPEN study, the largest of its kind, resulted in a wealth of nutritional biomarker data-measurable indicators of changes in organisms at the level of molecules or cells. A biomarker could help in understanding how environment and disease are related and about disease risks. Furthermore, its findings showed that the relative estimates of disease risk may be weakened by a food frequency questionnaire and a 24-hour questionnaire. Scientists have long recognized that self-reported information from questionnaires and interviews contains errors, but there has been uncertainty about the structure of such errors. For the proposed study, a food record and a food checklist-adjusted food frequency questionnaire will be compared with the previously used questionnaires, to determine whether the newer study instruments present less chance of measurement error. The results may provide better tools for a study on nutritional epidemiology, that is, the incidence and other aspects of disease and nutrition. OPEN study participants will be invited for follow-up.
Patients who completed the 1999-2000 study who are not currently pregnant or a liquid weight loss diet may be eligible for this study. The original study recruited men and women 40 to 69 years of age. A letter with summary results from the original OPEN study will be sent to each of the 482 participants.
Read more
Both the Food Record and the food checklist, called the Daily Food List, are instruments to be given. The Food Record asks the participant to record all foods and beverages consumed. The Daily Food List asks respondents to write in to the number of times a limited number of food categories are consumed. In addition, respondents will be asked to complete the National Cancer Institute Diet History Questionnaire (DHQ), identical to the one that they completed in the original OPEN study, regarding the previous 12 months. Participants will randomly be assigned to one of two groups. All will receive four study mailings over a 3-month period: the DHQ, First 4-Day Food Record (4-day FR), Second 4-day FR, and Booklet of 7-Day Food Lists (7-day FL), the latter listing selected foods that the participants will mark if consumed on the reporting day. Study Group A will receive the DHQ, first 4-day FR, second 4-day FR, and 7-day FL. Study Group B will receive the DHQ, 7-day FL, first 4-day FR, and second 4-day FR. Within 10 days after receiving the DHQ, participants will be called to schedule an appointment for a 30- to 45-minute visit. Participants will undergo the following procedures:
- Complete the Physical Activity Questionnaire (by telephone for those who have moved out of the local area or are unable to attend the visit)
- Have weight measured
- Be asked about whether he or she has recently developed certain medical conditions, experienced dramatic changes in diet, or gained special education in nutrition
The completion time for each instrument in dietary assessment is approximately as follows:
- DHQ-60 minutes.
- Each 4-day FR-80 minutes (20 minutes a day).
- 7-day FL-35 to 49 minutes (5 to 7 minutes a day).
Read the detailed description
NCI carries out extensive research and surveillance activities that rely on self-reported dietary information from questionnaires and interviews. Although scientists have long recognized that this information contains error, considerable uncertainty remains about its structure. The interpretation of findings from NCI's nutritional epidemiology and surveillance efforts is critically dependent on the assessment of dietary measurement error. We evaluated such measurement error in the previously conducted Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and 2000. This study, the largest study of its kind, used unbiased biomarkers of dietary intake (doubly labeled water for energy and 24-hour urinary nitrogen for protein) to assess measurement error in dietary assessment methods commonly used in epidemiology and surveillance research around the world. The landmark findings indicate that relative risk estimates in nutritional epidemiology may be severely attenuated by the use of food frequency questionnaires and that the conventional use of 24-hour dietary recalls as reference measurements may lead to severe underestimates of the extent of this attenuation. Key questions remain regarding whether these findings hold in diverse populations, for other dietary-report or physical activity instruments, across varying nutrients and food groups, and how measurement error affects relative risks in existing prospective cohorts. In light of the OPEN study findings, we would like to re-contact participants, for whom we already have a wealth of nutritional biomarker data, in order to assess the structure of measurement error with respect to two other self-reported dietary assessment instruments: the food record and a food checklist-adjusted food frequency questionnaire. Our intent is to evaluate whether these instruments might have more favorable measurement error structure than the food frequency questionnaire, thereby providing better tools for nutritional epidemiology.
- Conditions
- Diet, Diet Surveys
- Keywords
- Measurement Error, Dietary Assessment, Dietary Intake, Energy, Protein
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 |
|---|---|---|
| Volunteers | Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Not an intervention but we will assess biomarker data with self-reportdietary data to assess measurement error.
Measurement error in the reporting of dietary intakes
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start6 Nov 2003
- Primary completion22 Dec 2004
- Study completion24 Feb 2020
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 DietStudies 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
- Prospective
- Enrolment
- 384 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
- NCT00339677
- Sponsor's protocol ID
- 999904043
- Other IDs
- 04-C-N043
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2006
- Last updated
- 25 Feb 2020
- Results posted
- No
Publications
Subar AF, Kipnis V, Troiano RP, Midthune D, Schoeller DA, Bingham S, Sharbaugh CO, Trabulsi J, Runswick S, Ballard-Barbash R, Sunshine J, Schatzkin A. Using intake biomarkers to evaluate the extent of dietary misreporting in a large sample of adults: the OPEN study. Am J Epidemiol. 2003 Jul 1;158(1):1-13. doi: 10.1093/aje/kwg092.
PubMed 12835280Kipnis V, Subar AF, Midthune D, Freedman LS, Ballard-Barbash R, Troiano RP, Bingham S, Schoeller DA, Schatzkin A, Carroll RJ. Structure of dietary measurement error: results of the OPEN biomarker study. Am J Epidemiol. 2003 Jul 1;158(1):14-21; discussion 22-6. doi: 10.1093/aje/kwg091.
PubMed 12835281Freedman LS, Midthune D, Carroll RJ, Krebs-Smith S, Subar AF, Troiano RP, Dodd K, Schatzkin A, Bingham SA, Ferrari P, Kipnis V. Adjustments to improve the estimation of usual dietary intake distributions in the population. J Nutr. 2004 Jul;134(7):1836-43. doi: 10.1093/jn/134.7.1836.
PubMed 15226478
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recontacting Participants in the Observing Protein and Energy Nutrition Study: ReOPEN
- ClinicalTrials.gov ID
- NCT00339677
- Acronym / sponsor ID
- 999904043
- Conditions
- Diet, Diet Surveys
- Keywords
- Measurement Error, Dietary Assessment, Dietary Intake, Energy, Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Nov 2003 (actual)
- Primary completion
- 22 Dec 2004 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 21 Jun 2006 (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.
This study will evaluate the structure of error in self-reporting instruments on diet, in following up the Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and 2000. The OPEN study, the largest of its kind, resulted in a wealth of nutritional biomarker data-measurable indicators of changes in organisms at the level of molecules or cells. A biomarker could help in understanding how environment and disease are related and about disease risks. Furthermore, its findings showed that the relative estimates of disease risk may be weakened by a food frequency questionnaire and a 24-hour questionnaire. Scientists have long recognized that self-reported information from questionnaires and interviews contains errors, but there has been uncertainty about the structure of such errors. For the proposed study, a food record and a food checklist-adjusted food frequency questionnaire will be compared with the previously used questionnaires, to determine whether the newer study instruments present less chance of measurement error. The results may provide better tools for a study on nutritional epidemiology, that is, the incidence and other aspects of disease and nutrition. OPEN study participants will be invited for follow-up.
Patients who completed the 1999-2000 study who are not currently pregnant or a liquid weight loss diet may be eligible for this study. The original study recruited men and women 40 to 69 years of age. A letter with summary results from the original OPEN study will be sent to each of the 482 participants.
Both the Food Record and the food checklist, called the Daily Food List, are instruments to be given. The Food Record asks the participant to record all foods and beverages consumed. The Daily Food List asks respondents to write in to the number of times a limited number of food categories are consumed. In addition, respondents will be asked to complete the National Cancer Institute Diet History Questionnaire (DHQ), identical to the one that they completed in the original OPEN study, regarding the previous 12 months. Participants will randomly be assigned to one of two groups. All will receive four study mailings over a 3-month period: the DHQ, First 4-Day Food Record (4-day FR), Second 4-day FR, and Booklet of 7-Day Food Lists (7-day FL), the latter listing selected foods that the participants will mark if consumed on the reporting day. Study Group A will receive the DHQ, first 4-day FR, second 4-day FR, and 7-day FL. Study Group B will receive the DHQ, 7-day FL, first 4-day FR, and second 4-day FR. Within 10 days after receiving the DHQ, participants will be called to schedule an appointment for a 30- to 45-minute visit. Participants will undergo the following procedures:
- Complete the Physical Activity Questionnaire (by telephone for those who have moved out of the local area or are unable to attend the visit)
- Have weight measured
- Be asked about whether he or she has recently developed certain medical conditions, experienced dramatic changes in diet, or gained special education in nutrition
The completion time for each instrument in dietary assessment is approximately as follows:
- DHQ-60 minutes.
- Each 4-day FR-80 minutes (20 minutes a day).
- 7-day FL-35 to 49 minutes (5 to 7 minutes a day).
Detailed description
NCI carries out extensive research and surveillance activities that rely on self-reported dietary information from questionnaires and interviews. Although scientists have long recognized that this information contains error, considerable uncertainty remains about its structure. The interpretation of findings from NCI's nutritional epidemiology and surveillance efforts is critically dependent on the assessment of dietary measurement error. We evaluated such measurement error in the previously conducted Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and 2000. This study, the largest study of its kind, used unbiased biomarkers of dietary intake (doubly labeled water for energy and 24-hour urinary nitrogen for protein) to assess measurement error in dietary assessment methods commonly used in epidemiology and surveillance research around the world. The landmark findings indicate that relative risk estimates in nutritional epidemiology may be severely attenuated by the use of food frequency questionnaires and that the conventional use of 24-hour dietary recalls as reference measurements may lead to severe underestimates of the extent of this attenuation. Key questions remain regarding whether these findings hold in diverse populations, for other dietary-report or physical activity instruments, across varying nutrients and food groups, and how measurement error affects relative risks in existing prospective cohorts. In light of the OPEN study findings, we would like to re-contact participants, for whom we already have a wealth of nutritional biomarker data, in order to assess the structure of measurement error with respect to two other self-reported dietary assessment instruments: the food record and a food checklist-adjusted food frequency questionnaire. Our intent is to evaluate whether these instruments might have more favorable measurement error structure than the food frequency questionnaire, thereby providing better tools for nutritional epidemiology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | –Volunteers |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers.
Key inclusion criteria (1 listed)
- As this is a follow-up to a previous study with NCI SSIRB approval, there will be no recruitment of new participants. In the original OPEN study, we recruited a sample of men and women between 40-69 years of age. This age group represents those most likely to be recruited for large-scale epidemiological studies of diet and cancer. It is in this same group that we seek to assess measurement error problems for other dietary assessment instruments.
Key exclusion criteria (0 listed)
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
Not an intervention but we will assess biomarker data with self-reportdietary data to assess measurement error.
Time frame: 9 months
Measurement error in the reporting of dietary intakes
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 25 Feb 2020.
- Background: PubMed 12835280Subar AF, Kipnis V, Troiano RP, Midthune D, Schoeller DA, Bingham S, Sharbaugh CO, Trabulsi J, Runswick S, Ballard-Barbash R, Sunshine J, Schatzkin A. Using intake biomarkers to evaluate the extent of dietary misreporting in a large sample of adults: the OPEN study. Am J Epidemiol. 2003 Jul 1;158(1):1-13. doi: 10.1093/aje/kwg092.
- Background: PubMed 12835281Kipnis V, Subar AF, Midthune D, Freedman LS, Ballard-Barbash R, Troiano RP, Bingham S, Schoeller DA, Schatzkin A, Carroll RJ. Structure of dietary measurement error: results of the OPEN biomarker study. Am J Epidemiol. 2003 Jul 1;158(1):14-21; discussion 22-6. doi: 10.1093/aje/kwg091.
- Background: PubMed 15226478Freedman LS, Midthune D, Carroll RJ, Krebs-Smith S, Subar AF, Troiano RP, Dodd K, Schatzkin A, Bingham SA, Ferrari P, Kipnis V. Adjustments to improve the estimation of usual dietary intake distributions in the population. J Nutr. 2004 Jul;134(7):1836-43. doi: 10.1093/jn/134.7.1836.
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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 Diet 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?
The sponsor lists 1 inclusion and 0 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 25 Feb 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?
Not an intervention but we will assess biomarker data with self-reportdietary data to assess measurement error. (time frame: 9 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 NCT00339677, 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 25 Feb 2020.