NCT00339677

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

Completed Last updated 25 February 2020

What this trial tests

trial in Diet in 384 participants. Completed in 24 February 2020.

Timeline

6 November 2003

Primary endpoint
22 December 2004

24 February 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	384
Start date	6 November 2003
Primary completion	22 December 2004
Estimated completion	24 February 2020
Sites	1 location across United States

Conditions studied

• Diet — all drugs for Diet →
• Diet Surveys — all drugs for Diet Surveys →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 19 to 69, any sex, with Diet or Diet Surveys. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.