Recontacting Participants in the Observing Protein and Energy Nutrition (OPEN) Study: Re-OPEN
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 19 - 69 |
| Updated: | 3/22/2019 |
| Start Date: | November 6, 2003 |
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.
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).
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).
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.
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.
- INCLUSION CRITERIA:
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.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
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