Type2 DiabetesDietNCT03366532
Dietary Analyses in the Nurses' Health Study, Nurses' Health Study II, and Health Professionals Follow-Up Study
An observational study of Type2 Diabetes and Coronary Artery Disease, run by Harvard School of Public Health (HSPH).
Trial summary
To determine the relationships of a variety of nutrients, foods, and dietary patterns with the subsequent risk of developing type 2 diabetes, cardiovascular disease, and mortality in US men and women. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Coronary Artery Disease, Morality
- What is being tested?
- Dietary assessments
- How many people
- 289,900 participants
- Where
- No sites listed yet
- Study dates
- Aug 1980to Aug 2012
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Nurses' Health Study (NHS) consisted of 121,700 female registered nurses enrolled in 1976. The NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses. The Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals.
Who may be able to join
- Returned baseline food frequency questionnaires (FFQs).
Who cannot join
- Participants who had died or reported a diagnosis of diabetes (including type 1 diabetes, type 2 diabetes, and gestational diabetes for women), cardiovascular disease (CVD) or cancer at and before the baseline for the dietary analyses.
- Participants who left more than 70 of the 131 food items blank on the baseline FFQ, reported unusual total energy intake levels (<3,347 or >17,573 kJ/day for men, and <2,092 or >14,644 kJ/day for women), or had missing baseline dietary information.
- Participants who only completed the baseline questionnaire.
About this study
Official title: Dietary Analyses in the Nurses' Health Studies and Health Professionals Follow-Up Study (Diabetes, Cardiovascular Disease, and Mortality)
To determine the relationships of a variety of nutrients, foods, and dietary patterns with the subsequent risk of developing type 2 diabetes, cardiovascular disease, and mortality in US men and women.
Read the detailed description
The Nurses' Health Study (NHS) consisted of 121,700 female registered nurses aged 30 to 55 years from 11 US states who were enrolled in 1976. The NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses, 24 to 44 years of age, from 14 states. The Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals ranging in age from 40 to 75 years at enrollment from 50 states.
Study investigators sent follow-up questionnaires biennially to participants to update information on past medical history as well as lifestyle factors. Validated food frequency questionnaires (FFQs) were first sent in 1980 for the NHS, 1991 for the NHSII, and 1986 for the HPFS. Dietary assessments have been updated every 2-4 years since baseline. The FFQs collect information on average intake of each food item over the past year. It also specifies a common serving size for each item. Participants could select from one of nine intake frequency choices, ranging from less than once per month to six or more times per day. Participants also provided information on current use and dose of multivitamins and use of other vitamin supplements.
For these three cohorts, investigators repeatedly collected and updated information on several anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee intake, and physical activity level. Information was also collected on several major risk factors.
Study subjects reported new diagnoses biennially. After obtaining permission from participants, their medical and pathological records were acquired. Study physicians blinded to questionnaire information reviewed these records to confirm diagnoses of coronary heart disease and stroke. Self-reported diabetes diagnoses are confirmed using a validated supplementary questionnaire on symptoms, blood glucose levels, and medication use. Deaths are identified through reports from next of kin, postal authorities, or by searching the National Death Index.
All investigations regarding dietary factors in relation to type 2 diabetes, cardiovascular disease, and mortality have been approved by the institutional review boards of both Brigham and Women's Hospital and Harvard T.H Chan School of Public Health.
- Conditions
- Type2 Diabetes, Coronary Artery Disease, Morality, Stroke
- Being tested
- Dietary assessments
- Keywords
- diet, food frequency questionnaire, nutrient
- Medical subject headings
- Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary assessmentsOther
We use food frequency questionnaires to collect and update intake of foods and nutrients in observational studies. No intervention is involved.
| Study group | Role | What they receive |
|---|---|---|
| Nurses' Health Study | The NHS began in 1976 when 121,700 female nurses aged 33-55 years and residing in the United States responded to a baseline questionnaire. Receives: Other: Dietary assessments | |
| Nurses' Health Study II | The NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses, 24 to 44 years of age, from 14 states Receives: Other: Dietary assessments | |
| Health Professionals Follow-Up Study | The Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals ranging in age from 40 to 75 years at enrollment from 50 states Receives: Other: Dietary assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes
Type 2 diabetes
Measured: Since 1976, with active follow-up
Cardiovascular disease
Coronary heart disease and stroke
Measured: Since 1976, with active follow-up
Mortality
Deaths due to various causes
Measured: Since 1976, with active follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startAug 1980
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- 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
- 289,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Qi Sun, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366532
- Sponsor's protocol ID
- 2000-P-002221
- Acronym
- Diet
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Belanger CF, Hennekens CH, Rosner B, Speizer FE. The nurses' health study. Am J Nurs. 1978 Jun;78(6):1039-40. No abstract available.
PubMed 248266Rimm EB, Giovannucci EL, Willett WC, Colditz GA, Ascherio A, Rosner B, Stampfer MJ. Prospective study of alcohol consumption and risk of coronary disease in men. Lancet. 1991 Aug 24;338(8765):464-8. doi: 10.1016/0140-6736(91)90542-w.
PubMed 1678444Ma L, Liu G, Sampson L, Willett WC, Hu FB, Sun Q. Dietary glucosinolates and risk of type 2 diabetes in 3 prospective cohort studies. Am J Clin Nutr. 2018 Apr 1;107(4):617-625. doi: 10.1093/ajcn/nqy003.
PubMed 29635498
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Analyses in the Nurses' Health Studies and Health Professionals Follow-Up Study (Diabetes, Cardiovascular Disease, and Mortality)
- ClinicalTrials.gov ID
- NCT03366532
- Acronym / sponsor ID
- Diet / 2000-P-002221
- Conditions
- Type2 Diabetes, Coronary Artery Disease, Morality, Stroke
- Keywords
- diet, food frequency questionnaire, nutrient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289,900 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- Aug 1980 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Dec 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.
To determine the relationships of a variety of nutrients, foods, and dietary patterns with the subsequent risk of developing type 2 diabetes, cardiovascular disease, and mortality in US men and women.
Detailed description
The Nurses' Health Study (NHS) consisted of 121,700 female registered nurses aged 30 to 55 years from 11 US states who were enrolled in 1976. The NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses, 24 to 44 years of age, from 14 states. The Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals ranging in age from 40 to 75 years at enrollment from 50 states.
Study investigators sent follow-up questionnaires biennially to participants to update information on past medical history as well as lifestyle factors. Validated food frequency questionnaires (FFQs) were first sent in 1980 for the NHS, 1991 for the NHSII, and 1986 for the HPFS. Dietary assessments have been updated every 2-4 years since baseline. The FFQs collect information on average intake of each food item over the past year. It also specifies a common serving size for each item. Participants could select from one of nine intake frequency choices, ranging from less than once per month to six or more times per day. Participants also provided information on current use and dose of multivitamins and use of other vitamin supplements.
For these three cohorts, investigators repeatedly collected and updated information on several anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee intake, and physical activity level. Information was also collected on several major risk factors.
Study subjects reported new diagnoses biennially. After obtaining permission from participants, their medical and pathological records were acquired. Study physicians blinded to questionnaire information reviewed these records to confirm diagnoses of coronary heart disease and stroke. Self-reported diabetes diagnoses are confirmed using a validated supplementary questionnaire on symptoms, blood glucose levels, and medication use. Deaths are identified through reports from next of kin, postal authorities, or by searching the National Death Index.
All investigations regarding dietary factors in relation to type 2 diabetes, cardiovascular disease, and mortality have been approved by the institutional review boards of both Brigham and Women's Hospital and Harvard T.H Chan School of Public Health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurses' Health Study | – | Other: Dietary assessmentsThe NHS began in 1976 when 121,700 female nurses aged 33-55 years and residing in the United States responded to a baseline questionnaire. |
| Nurses' Health Study II | – | Other: Dietary assessmentsThe NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses, 24 to 44 years of age, from 14 states |
| Health Professionals Follow-Up Study | – | Other: Dietary assessmentsThe Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals ranging in age from 40 to 75 years at enrollment from 50 states |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Nurses' Health Study (NHS) consisted of 121,700 female registered nurses enrolled in 1976. The NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses. The Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals.
Key inclusion criteria (1 listed)
- Returned baseline food frequency questionnaires (FFQs).
Key exclusion criteria (3 listed)
- Participants who had died or reported a diagnosis of diabetes (including type 1 diabetes, type 2 diabetes, and gestational diabetes for women), cardiovascular disease (CVD) or cancer at and before the baseline for the dietary analyses.
- Participants who left more than 70 of the 131 food items blank on the baseline FFQ, reported unusual total energy intake levels (<3,347 or >17,573 kJ/day for men, and <2,092 or >14,644 kJ/day for women), or had missing baseline dietary information.
- Participants who only completed the baseline questionnaire.
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 |
|---|---|---|
| Dietary assessmentsWe use food frequency questionnaires to collect and update intake of foods and nutrients in observational studies. No intervention is involved. | Other | Health Professionals Follow-Up Study, Nurses' Health Study, Nurses' Health Study II |
Primary outcome
Type 2 diabetes
Time frame: Since 1976, with active follow-up
Type 2 diabetes
Cardiovascular disease
Time frame: Since 1976, with active follow-up
Coronary heart disease and stroke
Mortality
Time frame: Since 1976, with active follow-up
Deaths due to various causes
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 8 Dec 2017.
- Results publication: PubMed 248266Belanger CF, Hennekens CH, Rosner B, Speizer FE. The nurses' health study. Am J Nurs. 1978 Jun;78(6):1039-40. No abstract available.
- Results publication: PubMed 1678444Rimm EB, Giovannucci EL, Willett WC, Colditz GA, Ascherio A, Rosner B, Stampfer MJ. Prospective study of alcohol consumption and risk of coronary disease in men. Lancet. 1991 Aug 24;338(8765):464-8. doi: 10.1016/0140-6736(91)90542-w.
- Derived from this study: PubMed 29635498Ma L, Liu G, Sampson L, Willett WC, Hu FB, Sun Q. Dietary glucosinolates and risk of type 2 diabetes in 3 prospective cohort studies. Am J Clin Nutr. 2018 Apr 1;107(4):617-625. doi: 10.1093/ajcn/nqy003.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Coronary Artery Disease, run by Harvard School of Public Health (HSPH).
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 3 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Type 2 diabetes (time frame: Since 1976, with active follow-up). 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 NCT03366532, which also lists 3 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 8 Dec 2017.