NCT03615599

Brief Summary

The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
96,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress90%
Feb 2002Dec 2028

Study Start

First participant enrolled

February 1, 2002

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

11.9 years

First QC Date

June 29, 2018

Last Update Submit

January 28, 2026

Conditions

Keywords

Seventh-day Adventistsvegetarianmortalitycancerdietary patternsoy consumptiondairy consumptionplant-based

Outcome Measures

Primary Outcomes (1)

  • Incident cases of breast cancer among subjects with documented dietary habits.

    Incident cases of breast cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

    Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.

Secondary Outcomes (1)

  • Incident cases of prostate cancer among subjects with documented dietary intakes.

    Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.

Other Outcomes (1)

  • Incident cases of colorectal cancer among subjects with documented dietary habits.

    Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.

Study Arms (1)

Seventh-day Adventists

This is a prospective cohort study of 96,000 members of the Seventh-day Adventists Church in the United States and Canada age 30 and older at the time of enrollment who are proficient in English language.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample includes Seventh-day Adventist church members living in the USA and Canada who are 30 years and older, and who are sufficiently fluent in English to complete the lengthy lifestyle questionnaire. The study population is about 65% female. Approximately 25% of the cohort are Black/African Americans . Other ethnic minorities (e.g. Asian, Hispanic) are at much lower percentages (3-4 %).

You may qualify if:

  • Member of a Seventh-day Adventist church \>30 years of age Ability to read English Live in the US or Canada

You may not qualify if:

  • Less than 30 years of age
  • Church members who did not complete the baseline questionnaire.
  • Incarcerated or institutionalized people
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Related Publications (2)

  • Butler TL, Fraser GE, Beeson WL, Knutsen SF, Herring RP, Chan J, Sabate J, Montgomery S, Haddad E, Preston-Martin S, Bennett H, Jaceldo-Siegl K. Cohort profile: The Adventist Health Study-2 (AHS-2). Int J Epidemiol. 2008 Apr;37(2):260-5. doi: 10.1093/ije/dym165. Epub 2007 Aug 27. No abstract available.

    PMID: 17726038BACKGROUND
  • Fraser GE, Jacobsen BK, Knutsen SF, Mashchak A, Lloren JI. Tomato consumption and intake of lycopene as predictors of the incidence of prostate cancer: the Adventist Health Study-2. Cancer Causes Control. 2020 Apr;31(4):341-351. doi: 10.1007/s10552-020-01279-z. Epub 2020 Feb 25.

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat samples from a sample of the cohort (\~2500) are stored from which DNA material may be extracted when a study requires such data. Other stored bio-specimens from a sample of the cohort include adipose tissue, urine, blood, sputum, stool.

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsProstatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Gary E Fraser, MD,PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 29, 2018

First Posted

August 6, 2018

Study Start

February 1, 2002

Primary Completion

December 31, 2013

Study Completion (Estimated)

December 1, 2028

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Researchers must write a proposal describing how the data will be used and submit it to the Adventist Health Study data sharing committee for approval.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
on-going
Access Criteria
Data access will be given upon approval of proposal by the AHS-2 Review Committee.
More information

Locations