NCT03268577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,130

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

August 30, 2017

Last Update Submit

June 3, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • Saliva samples

    Will be analyzed for oral microbiomes and to characterize metabolic profiles of individuals.

    Up to 12 months

  • 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

  • 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

  • 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

Study Arms (1)

Prevention (diet and activity tracking)

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.

Other: Internet-Based InterventionDevice: Monitoring DeviceOther: Questionnaire Administration

Interventions

Complete ASA24

Prevention (diet and activity tracking)

Wear accelerometer and inclinometer physical activity monitors

Also known as: Monitor
Prevention (diet and activity tracking)

Ancillary studies

Prevention (diet and activity tracking)

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NCI Division of Cancer Control and Population Sciences

Rockville, Maryland, 20850, United States

Location

Related Publications (5)

  • Chang DC, Dodd KW, Abramowitz MK, Barrett B, Stinson EJ. Validation of Net Endogenous Acid Production from the Automated Self-Administered 24-h Recall, 4-d Food Records, and a Food Frequency Questionnaire Using Urine Markers. J Nutr. 2025 Jun 30:S0022-3166(25)00402-X. doi: 10.1016/j.tjnut.2025.06.017. Online ahead of print.

  • Abar L, Steele EM, Lee SK, Kahle L, Moore SC, Watts E, O'Connell CP, Matthews CE, Herrick KA, Hall KD, O'Connor LE, Freedman ND, Sinha R, Hong HG, Loftfield E. Identification and validation of poly-metabolite scores for diets high in ultra-processed food: An observational study and post-hoc randomized controlled crossover-feeding trial. PLoS Med. 2025 May 20;22(5):e1004560. doi: 10.1371/journal.pmed.1004560. eCollection 2025 May.

  • Chang DC, Stinson EJ, Dodd KW, Bowles HR, Herrick KA, Schoeller DA, Barrett B, Votruba SB, Krakoff J, Kavouras SA. Validation of Total Water Intake from the Automated Self-Administered 24-h Recall, 4-d Food Records, and a Food Frequency Questionnaire Using Doubly Labeled Water. J Nutr. 2023 Oct;153(10):3049-3057. doi: 10.1016/j.tjnut.2023.08.027. Epub 2023 Sep 3.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

saliva, urine, blood

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • heather bowles

    NCI Division of Cancer Control and Population Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

August 31, 2017

Study Start

January 1, 2012

Primary Completion

December 31, 2013

Study Completion

December 31, 2013

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations