Healthy SubjectNCT03268577
Internet-Based and Self-Reports in Assessing Diet and Physical Activity Within AARP
An observational study of Healthy Subject, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Internet-Based Intervention, Monitoring Device and Questionnaire Administration
- Type of treatment
- Medical device
- How many people
- 1,130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 31 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NCI Division of Cancer Control and Population Sciences
Rockville, Maryland, 20850
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Healthy Subject
- Being tested
- Internet-Based Intervention, Monitoring Device, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Complete ASA24
Internet-Based InterventionOther
Complete ACT24 reporting
Monitoring DeviceDevice
Also called Monitor
Wear accelerometer and inclinometer physical activity monitors
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Internet-Based Intervention; Device: Monitoring Device; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Saliva samples
Will be analyzed for oral microbiomes and to characterize metabolic profiles of individuals.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Jan 2012
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- heather bowles, Principal investigator, NCI Division of Cancer Control and Population Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268577
- Sponsor's protocol ID
- NCI-2017-01184
- Other IDs
- NCI-2017-01184, 11CN155, DCP-003
- Status last verified
- Jun 2020
- First submitted
- 30 Aug 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Malcomson FC, Lee SK, O'Connell CP, Shams-White MM, Reedy J, Playdon MC, Tabung FK, Watts EL, Moore SC, Hong HG, Loftfield E. Multi-metabolite Scores of Alignment with the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations in the Interactive Diet and Activity Tracking in AARP Study. J Nutr. 2026 Aug;156(8):101605. doi: 10.1016/j.tjnut.2026.101605. Epub 2026 May 22.
PubMed 42176992Chang 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.
PubMed 40602721Abar 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.
PubMed 40392756Chang 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.
PubMed 37660952Shams-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.
PubMed 34016140Subar 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.
PubMed 32819883
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03268577
- Acronym / sponsor ID
- NCI-2017-01184
- Conditions
- Healthy Subject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (diet and activity tracking) | – | Other: Internet-Based Intervention, Device: Monitoring Device, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionComplete ASA24 | Other | Prevention (diet and activity tracking) |
| Internet-Based InterventionComplete ACT24 reporting | Other | Prevention (diet and activity tracking) |
| Monitoring DeviceAlso: MonitorWear accelerometer and inclinometer physical activity monitors | Device | Prevention (diet and activity tracking) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (diet and activity tracking) |
Primary outcome
Self-reported energy intake from automated self-administered 24-hour dietary recall (ASA24), Diet History Questionnaire (DHQ)-II, and 4-day food record
Time frame: Up to 12 months
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.
Measurement error structure of self-reported active and sedentary behaviors (e.g. activity completed over time in 24-hours [ACT24], questionnaires)
Time frame: Up to 12 months
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.
24-hour urine samples
Time frame: Up to 12 months
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.
Fasting blood sample analyses
Time frame: Up to 12 months
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.
Saliva samples
Time frame: Up to 12 months
Will be analyzed for oral microbiomes and to characterize metabolic profiles of individuals.
Measurement error structure of self-reported dietary assessment instruments
Time frame: Up to 12 months
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.
Measurement error in self-reported total physical activity (measured in energy expenditure)
Time frame: Up to 12 months
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.
Reduction in measurement error
Time frame: Up to 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 42176992Malcomson FC, Lee SK, O'Connell CP, Shams-White MM, Reedy J, Playdon MC, Tabung FK, Watts EL, Moore SC, Hong HG, Loftfield E. Multi-metabolite Scores of Alignment with the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations in the Interactive Diet and Activity Tracking in AARP Study. J Nutr. 2026 Aug;156(8):101605. doi: 10.1016/j.tjnut.2026.101605. Epub 2026 May 22.
- Derived from this study: PubMed 40602721Chang 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.
- Derived from this study: PubMed 40392756Abar 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.
- Derived from this study: PubMed 37660952Chang 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.
- Derived from this study: PubMed 34016140Shams-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.
- Derived from this study: PubMed 32819883Subar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
heather bowles principal investigator
NCI Division of Cancer Control and Population Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subject, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported energy intake from automated self-administered 24-hour dietary recall (ASA24), Diet History Questionnaire (DHQ)-II, and 4-day food record (time frame: Up to 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268577, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.