DeathNCT00340015
A Prospective Study of Diet and Cancer in Members of the American Association of Retired Persons
An observational study of Death and Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). Read more about this study
- Who is it for?
- Ages 50 to 71 years
- How many people
- 566,401 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 1995to 25 Feb 2015
- 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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996.
Who may be able to join
- Patients participating will be selected from the American Association of Retired Persons age 50-69 living in one of the following state and metropolitan areas: California (minus Los Angeles county), Florida, Pennsylvania, New Jersey, Louisiana, North Carolina, Detroit, and Atlanta.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: NCI-AARP Diet and Health Study
This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.
In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.
Read the detailed description
This is a prospective cohort study to investigate relations among diet, lifestyle and cancer. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-96 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument. In 2004-2006 we mailed a follow-up questionnaire to all living participants to assess non-cancer endpoints and lifestyle factors.
- Keywords
- Cancer, Mortality, Lifestyle Factors, Nutrition, Prospective Cohort, Natural History
- Medical subject headings
- Death, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AARP | Members of the AARP, aged 50-71 years, and who resided in one of six states |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Cancer
All cancers
Measured: 12/31/2030
All cause and disease specific mortality
All cause and disease specific mortality
Measured: 12/31/2030
Chronic diseases
Chronic diseases
Measured: 12/31/2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start24 Oct 1995
- Primary completion25 Feb 2015
- Study completion25 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DeathStudies 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
- 566,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rashmi Sinha, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340015
- Sponsor's protocol ID
- 999995025
- Other IDs
- OH95-C-N025
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2006
- Last updated
- 5 Jan 2022
- Results posted
- No
Publications
Zhuang P, Wu F, Mao L, Zhu F, Zhang Y, Chen X, Jiao J, Zhang Y. Egg and cholesterol consumption and mortality from cardiovascular and different causes in the United States: A population-based cohort study. PLoS Med. 2021 Feb 9;18(2):e1003508. doi: 10.1371/journal.pmed.1003508. eCollection 2021 Feb.
PubMed 33561122Willis EA, Huang WY, Saint-Maurice PF, Leitzmann MF, Salerno EA, Matthews CE, Berndt SI. Increased frequency of intentional weight loss associated with reduced mortality: a prospective cohort analysis. BMC Med. 2020 Sep 17;18(1):248. doi: 10.1186/s12916-020-01716-5.
PubMed 32938465Zhuang P, Zhang Y, He W, Chen X, Chen J, He L, Mao L, Wu F, Jiao J. Dietary Fats in Relation to Total and Cause-Specific Mortality in a Prospective Cohort of 521 120 Individuals With 16 Years of Follow-Up. Circ Res. 2019 Mar;124(5):757-768. doi: 10.1161/CIRCRESAHA.118.314038.
PubMed 30636521Hashemian M, Murphy G, Etemadi A, Dawsey SM, Liao LM, Abnet CC. Nut and peanut butter consumption and the risk of esophageal and gastric cancer subtypes. Am J Clin Nutr. 2017 Sep;106(3):858-864. doi: 10.3945/ajcn.117.159467. Epub 2017 Aug 2.
PubMed 28768652Keadle SK, Arem H, Moore SC, Sampson JN, Matthews CE. Impact of changes in television viewing time and physical activity on longevity: a prospective cohort study. Int J Behav Nutr Phys Act. 2015 Dec 18;12:156. doi: 10.1186/s12966-015-0315-0.
PubMed 26678502Xu M, Huang T, Lee AW, Qi L, Cho S. Ready-to-Eat Cereal Consumption with Total and Cause-Specific Mortality: Prospective Analysis of 367,442 Individuals. J Am Coll Nutr. 2016;35(3):217-23. doi: 10.1080/07315724.2014.971193. Epub 2015 Nov 23.
PubMed 26595440Keadle SK, Moore SC, Sampson JN, Xiao Q, Albanes D, Matthews CE. Causes of Death Associated With Prolonged TV Viewing: NIH-AARP Diet and Health Study. Am J Prev Med. 2015 Dec;49(6):811-21. doi: 10.1016/j.amepre.2015.05.023. Epub 2015 Jul 26.
PubMed 26215832Kabat GC, Matthews CE, Kamensky V, Hollenbeck AR, Rohan TE. Adherence to cancer prevention guidelines and cancer incidence, cancer mortality, and total mortality: a prospective cohort study. Am J Clin Nutr. 2015 Mar;101(3):558-69. doi: 10.3945/ajcn.114.094854. Epub 2015 Jan 7.
PubMed 25733641Matthews CE, Moore SC, Sampson J, Blair A, Xiao Q, Keadle SK, Hollenbeck A, Park Y. Mortality Benefits for Replacing Sitting Time with Different Physical Activities. Med Sci Sports Exerc. 2015 Sep;47(9):1833-40. doi: 10.1249/MSS.0000000000000621.
PubMed 25628179Jiao L, Stolzenberg-Solomon R, Zimmerman TP, Duan Z, Chen L, Kahle L, Risch A, Subar AF, Cross AJ, Hollenbeck A, Vlassara H, Striker G, Sinha R. Dietary consumption of advanced glycation end products and pancreatic cancer in the prospective NIH-AARP Diet and Health Study. Am J Clin Nutr. 2015 Jan;101(1):126-34. doi: 10.3945/ajcn.114.098061. Epub 2014 Nov 19.
PubMed 25527756Tasevska N, Park Y, Jiao L, Hollenbeck A, Subar AF, Potischman N. Sugars and risk of mortality in the NIH-AARP Diet and Health Study. Am J Clin Nutr. 2014 May;99(5):1077-88. doi: 10.3945/ajcn.113.069369. Epub 2014 Feb 19.
PubMed 24552754Li WQ, Park Y, Wu JW, Goldstein AM, Taylor PR, Hollenbeck AR, Freedman ND, Abnet CC. Index-based dietary patterns and risk of head and neck cancer in a large prospective study. Am J Clin Nutr. 2014 Mar;99(3):559-66. doi: 10.3945/ajcn.113.073163. Epub 2014 Jan 8.
PubMed 24401718Daniel CR, Park Y, Chow WH, Graubard BI, Hollenbeck AR, Sinha R. Intake of fiber and fiber-rich plant foods is associated with a lower risk of renal cell carcinoma in a large US cohort. Am J Clin Nutr. 2013 May;97(5):1036-43. doi: 10.3945/ajcn.112.045351. Epub 2013 Mar 20.
PubMed 23515007Sinha R, Cross AJ, Daniel CR, Graubard BI, Wu JW, Hollenbeck AR, Gunter MJ, Park Y, Freedman ND. Caffeinated and decaffeinated coffee and tea intakes and risk of colorectal cancer in a large prospective study. Am J Clin Nutr. 2012 Aug;96(2):374-81. doi: 10.3945/ajcn.111.031328. Epub 2012 Jun 13.
PubMed 22695871Daniel CR, Sinha R, Park Y, Graubard BI, Hollenbeck AR, Morton LM, Cross AJ. Meat intake is not associated with risk of non-Hodgkin lymphoma in a large prospective cohort of U.S. men and women. J Nutr. 2012 Jun;142(6):1074-80. doi: 10.3945/jn.112.158113. Epub 2012 Apr 25.
PubMed 22535761
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCI-AARP Diet and Health Study
- ClinicalTrials.gov ID
- NCT00340015
- Acronym / sponsor ID
- 999995025
- Keywords
- Cancer, Mortality, Lifestyle Factors, Nutrition, Prospective Cohort, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 566,401 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Oct 1995 (actual)
- Primary completion
- 25 Feb 2015 (actual)
- Study completion
- 25 Feb 2015 (actual)
- First posted
- 21 Jun 2006 (estimated)
- 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 is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.
In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.
Detailed description
This is a prospective cohort study to investigate relations among diet, lifestyle and cancer. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-96 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument. In 2004-2006 we mailed a follow-up questionnaire to all living participants to assess non-cancer endpoints and lifestyle factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AARP | – | –Members of the AARP, aged 50-71 years, and who resided in one of six states |
Who may qualify
- Ages
- 50 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996.
Key inclusion criteria (1 listed)
- Patients participating will be selected from the American Association of Retired Persons age 50-69 living in one of the following state and metropolitan areas: California (minus Los Angeles county), Florida, Pennsylvania, New Jersey, Louisiana, North Carolina, Detroit, and Atlanta.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Cancer
Time frame: 12/31/2030
All cancers
All cause and disease specific mortality
Time frame: 12/31/2030
All cause and disease specific mortality
Chronic diseases
Time frame: 12/31/2030
Chronic diseases
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 5 Jan 2022.
- Derived from this study: PubMed 33561122Zhuang P, Wu F, Mao L, Zhu F, Zhang Y, Chen X, Jiao J, Zhang Y. Egg and cholesterol consumption and mortality from cardiovascular and different causes in the United States: A population-based cohort study. PLoS Med. 2021 Feb 9;18(2):e1003508. doi: 10.1371/journal.pmed.1003508. eCollection 2021 Feb.
- Derived from this study: PubMed 32938465Willis EA, Huang WY, Saint-Maurice PF, Leitzmann MF, Salerno EA, Matthews CE, Berndt SI. Increased frequency of intentional weight loss associated with reduced mortality: a prospective cohort analysis. BMC Med. 2020 Sep 17;18(1):248. doi: 10.1186/s12916-020-01716-5.
- Derived from this study: PubMed 30636521Zhuang P, Zhang Y, He W, Chen X, Chen J, He L, Mao L, Wu F, Jiao J. Dietary Fats in Relation to Total and Cause-Specific Mortality in a Prospective Cohort of 521 120 Individuals With 16 Years of Follow-Up. Circ Res. 2019 Mar;124(5):757-768. doi: 10.1161/CIRCRESAHA.118.314038.
- Derived from this study: PubMed 28768652Hashemian M, Murphy G, Etemadi A, Dawsey SM, Liao LM, Abnet CC. Nut and peanut butter consumption and the risk of esophageal and gastric cancer subtypes. Am J Clin Nutr. 2017 Sep;106(3):858-864. doi: 10.3945/ajcn.117.159467. Epub 2017 Aug 2.
- Derived from this study: PubMed 26678502Keadle SK, Arem H, Moore SC, Sampson JN, Matthews CE. Impact of changes in television viewing time and physical activity on longevity: a prospective cohort study. Int J Behav Nutr Phys Act. 2015 Dec 18;12:156. doi: 10.1186/s12966-015-0315-0.
- Derived from this study: PubMed 26595440Xu M, Huang T, Lee AW, Qi L, Cho S. Ready-to-Eat Cereal Consumption with Total and Cause-Specific Mortality: Prospective Analysis of 367,442 Individuals. J Am Coll Nutr. 2016;35(3):217-23. doi: 10.1080/07315724.2014.971193. Epub 2015 Nov 23.
- Derived from this study: PubMed 26215832Keadle SK, Moore SC, Sampson JN, Xiao Q, Albanes D, Matthews CE. Causes of Death Associated With Prolonged TV Viewing: NIH-AARP Diet and Health Study. Am J Prev Med. 2015 Dec;49(6):811-21. doi: 10.1016/j.amepre.2015.05.023. Epub 2015 Jul 26.
- Derived from this study: PubMed 25733641Kabat GC, Matthews CE, Kamensky V, Hollenbeck AR, Rohan TE. Adherence to cancer prevention guidelines and cancer incidence, cancer mortality, and total mortality: a prospective cohort study. Am J Clin Nutr. 2015 Mar;101(3):558-69. doi: 10.3945/ajcn.114.094854. Epub 2015 Jan 7.
- Derived from this study: PubMed 25628179Matthews CE, Moore SC, Sampson J, Blair A, Xiao Q, Keadle SK, Hollenbeck A, Park Y. Mortality Benefits for Replacing Sitting Time with Different Physical Activities. Med Sci Sports Exerc. 2015 Sep;47(9):1833-40. doi: 10.1249/MSS.0000000000000621.
- Derived from this study: PubMed 25527756Jiao L, Stolzenberg-Solomon R, Zimmerman TP, Duan Z, Chen L, Kahle L, Risch A, Subar AF, Cross AJ, Hollenbeck A, Vlassara H, Striker G, Sinha R. Dietary consumption of advanced glycation end products and pancreatic cancer in the prospective NIH-AARP Diet and Health Study. Am J Clin Nutr. 2015 Jan;101(1):126-34. doi: 10.3945/ajcn.114.098061. Epub 2014 Nov 19.
- Derived from this study: PubMed 24552754Tasevska N, Park Y, Jiao L, Hollenbeck A, Subar AF, Potischman N. Sugars and risk of mortality in the NIH-AARP Diet and Health Study. Am J Clin Nutr. 2014 May;99(5):1077-88. doi: 10.3945/ajcn.113.069369. Epub 2014 Feb 19.
- Derived from this study: PubMed 24401718Li WQ, Park Y, Wu JW, Goldstein AM, Taylor PR, Hollenbeck AR, Freedman ND, Abnet CC. Index-based dietary patterns and risk of head and neck cancer in a large prospective study. Am J Clin Nutr. 2014 Mar;99(3):559-66. doi: 10.3945/ajcn.113.073163. Epub 2014 Jan 8.
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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.
Rashmi Sinha, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Death and Cancer, 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 1 inclusion and 0 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 5 Jan 2022. 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?
Incident Cancer (time frame: 12/31/2030). The study lists 3 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 NCT00340015, which also lists 17 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 5 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.