Clinical trial NCT03268577: Internet-Based and Self-Reports in Assessing Diet and Physical Activity Within AARP
Official title: Interactive Diet and Activity Tracking in AARP (IDATA): Biomarker Based Validation Study of Internet-Based and Conventional Self-Report Instruments for Assessing Diet and Physical Activity Within AARP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subject
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2017-08-31
Enrollment: 1130
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members within the existing NIH-AARP Diet and Health Study members (aged 50-71 in 1995-96) and younger AARP members born after 1945 ('baby boomers') and living in the Pittsburgh area in Pennsylvania

Brief summary: This research trial studies how well internet-based and self-report instruments measure food intake and physical activity levels and their relationship with disease within American Association of Retired Persons (AARP) members. Comparing new internet-based questionnaires developed by the National Cancer Institute that report all the foods consumed and activities performed in an entire day to standardized physical measurements may help to determine if the information collected is accurate.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the measurement error structure of self-reported dietary assessment instruments, including, a food frequency questionnaire (National Cancer Institute \[NCI\]'s Diet History Questionnaire-II \[DHQ-II\]), and 24-hour recalls using the new automated self-administered 24-hour dietary recall (ASA24) instrument with respect to absolute energy intake, absolute protein intake, and protein density-and potentially other nutritional factors such as potassium intake.

II. Investigate the measurement error structure associated with self-reported active and sedentary behaviors, including multiple administrations of a new 24-hour recall (activity completed over time in 24-hours \[ACT24\]) and selected questionnaires using energy expenditure from doubly labeled water (DLW) and physical activities measures of physical activity monitors as reference instruments.

III. Evaluate alternative analytic approaches for combining different types of self-report data on diet and physical activity-related behaviors as well as self-report plus objective data (derived from activity monitors, heart rate monitors e.g.).

IV. Within the context of an AARP-based cohort, explore the adjustment of observed RRs for several key cancer hypotheses related to diet and physical activity based on the measurement error data provided by the new study.

V. Evaluate the potential for 'energy adjustment' that incorporates physical activity and body size.

OUTLINE:

Patients complete the ASA24 about foods, cooking methods, and other aspects of diet every 2 months for up to 6 times, and complete ACT24 about activities and time reporting every 2 months for up to 6 times. Patients also complete DHQ-II questionnaires at the beginning and end of the study about the frequency and portion sizes of foods consumed over the past 12 months, provide a 7-day food checklist twice with the DHQ-II, and provide a 4-day food record twice, once every 6 months. Physical activity monitors are worn to measure movement at different intensity levels and sitting or standing periods, twice during the study with 6 months between each time they are worn.

Eligibility criteria: Exclusion Criteria:

* Non-English speaking or reading
* Weight loss diet (liquid or medications)
* Diabetes
* Body mass index \< 18.5 or \>= 40 (kg/m\^2)
* History of renal failure, congestive heart failure, or other conditions involving disturbances in fluid balance
* Limited mobility
* Use of supplemental oxygen
* Allergy to para-amino benzoic acid (PABA)
* No access to high-speed internet
* No more than one AARP member in the household can participate in the study

Primary outcomes:
measure: Self-reported energy intake from automated self-administered 24-hour dietary recall (ASA24), Diet History Questionnaire (DHQ)-II, and 4-day food record
timeFrame: Up to 12 months
measure: Measurement error structure of self-reported active and sedentary behaviors (e.g. activity completed over time in 24-hours [ACT24], questionnaires)
timeFrame: Up to 12 months
measure: 24-hour urine samples
timeFrame: Up to 12 months
measure: Fasting blood sample analyses
timeFrame: Up to 12 months
measure: Saliva samples
timeFrame: Up to 12 months
measure: Measurement error structure of self-reported dietary assessment instruments
timeFrame: Up to 12 months
measure: Measurement error in self-reported total physical activity (measured in energy expenditure)
timeFrame: Up to 12 months
measure: Reduction in measurement error
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: NCI Division of Cancer Control and Population Sciences
state: Maryland
Study officials:
affiliation: NCI Division of Cancer Control and Population Sciences
name: heather bowles
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shams-White MM, Korycinski RW, Dodd KW, Barrett B, Jacobs S, Subar AF, Park Y, Bowles HR. Examining the association between meal context and diet quality: an observational study of meal context in older adults. Int J Behav Nutr Phys Act. 2021 May 20;18(1):67. doi: 10.1186/s12966-021-01122-x.
citation: Subar AF, Potischman N, Dodd KW, Thompson FE, Baer DJ, Schoeller DA, Midthune D, Kipnis V, Kirkpatrick SI, Mittl B, Zimmerman TP, Douglass D, Bowles HR, Park Y. Performance and Feasibility of Recalls Completed Using the Automated Self-Administered 24-Hour Dietary Assessment Tool in Relation to Other Self-Report Tools and Biomarkers in the Interactive Diet and Activity Tracking in AARP (IDATA) Study. J Acad Nutr Diet. 2020 Nov;120(11):1805-1820. doi: 10.1016/j.jand.2020.06.015. Epub 2020 Aug 17.