Internet-Based and Self-Reports in Assessing Diet and Physical Activity Within AARP

Healthy Subject Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268577
• Other study ID #: NCI-2017-01184
• Secondary ID: NCI-2017-0118411
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2013

Study information

• Verified date: June 2020
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1130
• Est. completion date: December 31, 2013
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Other:
• Internet-Based Intervention
Complete ASA24
• Internet-Based Intervention
Complete ACT24 reporting

Device:
• Monitoring Device
Wear accelerometer and inclinometer physical activity monitors

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	NCI Division of Cancer Control and Population Sciences	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported energy intake from automated self-administered 24-hour dietary recall (ASA24), Diet History Questionnaire (DHQ)-II, and 4-day food record	Will be evaluated against energy intake measured by doubly labeled water (DLW). Dietary intake of protein, potassium, and other nutrients will be compared to urinary nitrogen (UN), urinary potassium, and other nutrients measured in urine and blood.	Up to 12 months
Primary	Measurement error structure of self-reported active and sedentary behaviors (e.g. activity completed over time in 24-hours [ACT24], questionnaires)	Will be examined using energy expenditure measured by DLW, physical activity monitor data, and hear rate monitor data. Data will be also used to evaluate alternative statistical methods for combining different types of self-report data on diet and physical activity-related behaviors as well as self-report plus objectively measured data.	Up to 12 months
Primary	24-hour urine samples	Will be analyzed for UN, potassium, para-amino benzoic acid (PABA), and other nutrients that are potential objective markers of intakes. First morning void urine also will be evaluated for its potential to be used as a source of biomarkers replacing 24-hr urine. Urine will be analyzed to characterize metabolic profiles of individuals.	Up to 12 months
Primary	Fasting blood sample analyses	Will be processed to extract plasma and red and white blood cells, and analyzed in the future for vitamin C, folate, vitamin E, vitamin A, carotenoids, lipids, fatty acids and other nutrients.	Up to 12 months
Primary	Saliva samples	Will be analyzed for oral microbiomes and to characterize metabolic profiles of individuals.	Up to 12 months
Primary	Measurement error structure of self-reported dietary assessment instruments	Evaluated using latent-variable (measurement error) models. The models allow self-reported dietary intake to have intake-related and person-specific biases, but assume that reference biomarkers (doubly-labeled water, urinary nitrogen, urinary potassium) provide unbiased estimates of true usual intake at the individual level. Such models allow one to estimate the joint distribution of true and reported intake, and to estimate parameters of interest such as the correlation of true and reported intake and the "attenuation factor", or slope in the regression of true intake on reported intake.	Up to 12 months
Primary	Measurement error in self-reported total physical activity (measured in energy expenditure)	Evaluated using latent-variable (measurement error) models. The models allow total energy expenditure derived from a physical activity monitor to have intake-related and person-specific biases, but assume that reference biomarkers (doubly-labeled water, urinary nitrogen, urinary potassium) provide unbiased estimates of true usual intake at the individual level. Such models to help develop better algorithms for estimating total energy expenditure from the measurements of physical activity monitors. For other physical activity measures of interest, such as minutes of vigorous activity or minutes of sedentary time per day, will use the physical activity monitors to derive approximately unbiased estimates that can be used as reference instruments.	Up to 12 months
Primary	Reduction in measurement error	Will use multivariate measurement error models to estimate the joint distribution of true and reported values (nutrient intake, total energy, physical activity, body size). Then calculate residual reported intake (given reported total energy, physical activity and body size) and residual true intake (given true total energy, physical activity and body size), and assess the measurement error properties of reported residual intake as a measure of true residual intake. Specifically, will calculate the correlation of true and reported residual intake and the attenuation factor for residual reported intake and compare them to the same measures calculated for the simpler model that adjusts only for energy.	Up to 12 months