Clinical trial NCT01164254: Feasibility Study of a Web-Based Automated Self-Administered 24-hour Dietary Recall (ASA 24) and a Physical Activity 24-hour Recall
Official title: Feasibility Study of a Web-Based Automated Self-Administered 24-hour Dietary Recall (ASA 24) and a Physical Activity 24-Hour Recall (ACT24)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Exposure Assessment
Web-Based Dietary Assessment
Web-Based Physical Activity Assessment
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2010-07-16
Enrollment: 627
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief 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.

Detailed 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.

Eligibility criteria: * 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.

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Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Charles E Matthews, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: