Healthful Diets and Risk of Hearing Loss
21. november 2017 opdateret af: Gary C Curhan, Brigham and Women's Hospital
Healthful Dietary Patterns and Risk of Hearing Loss in Women
To prospectively examine the relations between adherence scores for three healthful dietary patterns, the Alternate Mediterranean diet (AMED), the Dietary Approaches to Stop Hypertension (DASH), and the Alternative Healthy Eating Index (AHEI-2010), and risk of hearing loss in the Nurses' Health Study II.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
70966
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
27 år til 66 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The Conservation of Hearing Study (CHEARS) examines risk factors for hearing loss among participants in the Nurses' Health Study II, an ongoing cohort study of 116,430 female registered nurses in the US, aged 25-42 at enrollment in 1989.
Participants have been followed by biennial mailed questionnaires that elicit updated information on diet, lifestyle, and various health outcomes; the follow-up rate over 26 years exceeds 90% of the eligible person-time.
After exclusions, a total of 70,966 women were included in the analyses.
Beskrivelse
Inclusion Criteria:
- The investigators limited the study to women who provided information on their hearing on the 2009 or 2013 questionnaire.
Exclusion Criteria:
- The investigators excluded those who did not provide responses to the hearing questions on either questionnaire, reported a hearing problem that began before baseline for the current analysis (1991) or did not report date of onset, or reported cancer other than non-melanoma skin cancer. The investigators also excluded women who did not complete the baseline diet questionnaire and who had missing diet information for each subsequent time period.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Nurses' Health Study II
Nurses' Health Study II, an ongoing cohort study of 116,430 female registered nurses in the US, aged 25-42 at enrollment in 1989.
Participants have been followed by biennial mailed questionnaires that elicit updated information on diet, lifestyle, and various health outcomes; the follow-up rate over 26 years exceeds 90% of the eligible person-time.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hearing loss
Tidsramme: 1991-2013
|
The primary outcome, self-reported hearing loss that was moderate or worse in severity, was determined based on responses to the 2009 and 2013 questionnaires on which participants were asked about their hearing.
On the 2009 main questionnaire, participants were asked, "Do you have a hearing problem?" (no, mild, moderate, severe), and "At what age did you first notice a change in your hearing?"
On the 2013 main questionnaire, participants were asked, "Which best describes your hearing?" (excellent, good, a little hearing trouble, moderate hearing trouble, deaf), and "Have you noticed a change in your hearing?" and, if the response was "Yes," "At what age did you first notice a change in your hearing?"
|
1991-2013
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
hearing loss in HSSQ
Tidsramme: 1991-2013
|
Detailed hearing-related information was collected electronically in 2012 supplemental questionnaire from a representative subcohort of NHS II participants (n= 33,102) with and without reported hearing problems, including information on previous evaluation for hearing loss, laterality (unilateral or bilateral), and identified causes of hearing loss (e.g.
ototoxic medications, ear trauma, otosclerosis, cholesteatoma, Meniere's disease, chronic ear infection).
Data from the HSSQ were used to conduct sensitivity analyses using more refined case definitions (e.g.
excluding known etiologies and unilateral hearing loss).
|
1991-2013
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gary Curhan, MD, ScD, Brigham and Women's Hospital/Harvard Medical School
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 1991
Primær færdiggørelse (Faktiske)
30. juni 2013
Studieafslutning (Faktiske)
30. juni 2013
Datoer for studieregistrering
Først indsendt
19. november 2017
Først indsendt, der opfyldte QC-kriterier
21. november 2017
Først opslået (Faktiske)
22. november 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. november 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007P000876
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
For investigators who wish to use the investigators' data, the investigators have adopted a data enclave approach to data sharing within the Nurses' Health Study II cohort.
Along with a general description of the cohorts and questionnaires that have been used since 1989 (NHS II), guidelines are available upon request for outside users to access the resources of our studies.
Typically, an outside user prepares a brief proposal that is reviewed by the Channing investigator group to identify a local investigator to assist the outside investigator.
If uncertainty arises as to the merit of a request, the External Advisory Committees makes a final decision.
After approval, the investigators facilitate access to our data either through programming support or orientation to the data.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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