Recontacting Participants in the Observing Protein and Energy Nutrition (OPEN) Study: Re-OPEN

NCT00339677 | Completed

• 2 other identifiers: 99990404304-C-N043
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Diet; Diet Surveys

Keywords

Measurement Error; Dietary Assessment; Dietary Intake; Energy; Protein

Outcome Measures

Primary Outcomes (1)

• 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

  9 months

Study Arms (1)

Volunteers

Volunteers

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 12835280 BACKGROUND

• Kipnis 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.

  PMID: 12835281 BACKGROUND

• Freedman 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.

  PMID: 15226478 BACKGROUND

Study Officials

• Nancy A. Potischman, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: November 6, 2003
• Primary Completion: December 22, 2004
• Study Completion: February 24, 2020
• Last Updated: February 25, 2020

Record last verified: 2019-06

Locations

US (1)