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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01164254
Other study ID # 999908152
Secondary ID 08-C-N152
Status Completed
Phase
First received
Last updated
Start date May 28, 2008
Est. completion date November 30, 2016

Study information

Verified date November 30, 2016
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In spite of long-standing hypothesis relating diet and physical activity to several cancers, diet and physical activity-cancer associations have been modest at best and often inconsistent in epidemiologic studies. Investigators around the world have become increasingly concerned that error in the measurement of both diet and physical activity is compromising our ability to detect these important but modest associations. Most commonly used diet and physical activity assessment methods have been based on a relatively small set of questions (e.g. 124 food items consumed or 5-10 physical activities in the past 12 months). Recent developments in computer technology provide an opportunity to use internet-based instruments to assess an individual s diet and physical activity more accurately and cost effectively.


Description:

In spite of long-standing hypothesis relating diet and physical activity to several cancers, diet and physical activity-cancer associations have been modest at best and often inconsistent in epidemiologic studies. Investigators around the world have become increasingly concerned that error in the measurement of both diet and physical activity is compromising our ability to detect these important but modest associations. Most commonly used diet and physical activity assessment methods have been based on a relatively small set of questions (e.g. 124 food items consumed or 5-10 physical activities in the past 12 months). Recent developments in computer technology provide an opportunity to use internet-based instruments to assess an individual s diet and physical activity more accurately and cost effectively.

NCI has been developing two web-based instruments, an automated self-administered 24-hour dietary recall (ASA24) and a physical activity 24-hour recall (ACT24), which can be administered several times over a year. Although these two instruments have the potential to qualitatively improve exposure assessment (at relatively low cost), they need to be evaluated for feasibility before being incorporated in cohorts on a large scale. Therefore, we propose to test ASA24 and ACT24 among AARP members aged 50 years and over to evaluate technical problems, determine response rates, and estimate the range of dietary intake and physical activity. In addition, we propose to include in this feasibility study two web-based versions of conventional questionnaires (lifestyle and medical history questionnaire and diet history questionnaire) as well as two software systems needed to conduct a web-based study (the automated Study Management System and Web Survey Management System). We will initially target 15,000 AARP members, expecting that approximately 2,000 individuals will agree to participate in the study and about 1,250 participants will complete ASA24 and ACT24 twice.

These web-based instruments and accompanying system tools represent a novel approach to carrying out diet and lifestyle research. The computerized, web-based study method can be applied to any observational study, large or small, case-control or cohort, as well as randomized controlled trials. This feasibility study will provide an opportunity to assess the feasibility of constructing large web-based cohort studies and characterize potential participants.


Recruitment information / eligibility

Status Completed
Enrollment 627
Est. completion date November 30, 2016
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility - We will recruit 5,000 subjects from the existing NIH-AARP study participants who are currently 62 to 83 years old. To include individuals who are at least 50 years old, we will expand our recruitment effort to 10,000 new AARP members who are at least 50 years old and not currently NIH-AARP study cohort members. We will target individuals residing in one of the following states: Florida; Pennsylvania; New Jersey; Louisiana; North Carolina; California; Detroit; Michigan; and Atlanta, Georgia, Nevada, Arizona, Texas, Illinois, Washington, Wisconsin, Colorado, Connecticut, Kentucky, Utah and Massachusetts (subject to change due to availability of high-quality state cancer registries). The names and addresses of new AARP members will be provided by AARP.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Cancer Institute (NCI), 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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