Project Baseline Health Study

This study is the first initiative of Project Baseline, a broader effort designed to develop a well-defined reference, or "baseline," of good health as well as a rich data platform that may be used to better understand the transition from health to disease and identify additional risk factors for disease. Project Baseline endeavors to test and develop new tools and technologies to collect, organize, and activate health information.

Study Overview

• Status: Active, not recruiting
• Conditions: All

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • California
    • South San Francisco, California, United States, 94080
      • Baseline Study
    • Stanford, California, United States, 94305
      • Stanford Medicine
    • Westlake Village, California, United States, 91361
      • California Health and Longevity Institute
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University School of Medicine
    • Kannapolis, North Carolina, United States, 28081
      • Duke University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The Project Baseline study population will be composed of adults across the health spectrum, including exceptionally healthy participants, participants at risk of disease, and participants with current disease.

Description

Inclusion Criteria:

• Age ≥ 18
• U.S. Resident
• Able to speak and read English
• Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

• Individuals working on Project Baseline, including the Baseline Study
• Known severe allergy to nickel or metal jewelry

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

General Population; An unlimited number of participants will be accepted into a Baseline registry. From the Baseline registry, approximately 10,000 participants will be selected for the Baseline Study. Participant enrollment for the Baseline Study will be stratified by age, sex and risk factors and will aim to reflect the race and ethnicity distribution within the U.S.. The population includes a broad range of participants across the health spectrum, including exceptionally healthy participants, participants at risk of disease, and participants with current disease. The study population will be enriched for participants with an elevated risk of primary cardiovascular disease, lung cancer, and/or breast/ovarian cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Develop a set of scalable and standardized tools for acquiring, organizing, and analyzing clinical, molecular, imaging, sensor, self-reported, behavioral, environmental, and other health-related measurements	For the duration of the study
Evaluate the use of sensor technologies for the collection of continuous, accurate health information	For the duration of the study
Create a dataset encompassing a wide spectrum of phenotypic measures for future exploratory analysis	For the duration of the study
Measure the phenotypic diversity observed among a participant population, defining a range of expected values for multiple types of data	For the duration of the study
Identify biomarkers of disease-related transitions, including those related to cardiovascular disease and cancer	For the duration of the study

Collaborators and Investigators

• Sponsor: Baseline Study LLC
• Collaborators: Duke University; Stanford University; Verily Life Sciences LLC; Google LLC.

Publications and helpful links

General Publications

• Haddad F, Cauwenberghs N, Daubert MA, Kobayashi Y, Bloomfield GS, Fleischman D, Koweek L, Maron DJ, Rodriguez F, Liao YJ, Moneghetti K, Amsallem M, Mega J, Hernandez A, Califf R, Mahaffey KW, Shah SH, Kuznetsova T, Douglas PS; Project Baseline Health Study Investigators. Association of left ventricular diastolic function with coronary artery calcium score: A Project Baseline Health Study. J Cardiovasc Comput Tomogr. 2022 Nov-Dec;16(6):498-508. doi: 10.1016/j.jcct.2022.06.003. Epub 2022 Jul 5.
• Chatterjee R, Kwee LC, Pagidipati N, Koweek LH, Mettu PS, Haddad F, Maron DJ, Rodriguez F, Mega JL, Hernandez A, Mahaffey K, Palaniappan L, Shah SH; Project Baseline Health Study. Multi-dimensional characterization of prediabetes in the Project Baseline Health Study. Cardiovasc Diabetol. 2022 Jul 18;21(1):134. doi: 10.1186/s12933-022-01565-x.
• Califf RM, Wong C, Doraiswamy PM, Hong DS, Miller DP, Mega JL; Baseline Study Group. Biological and clinical correlates of the patient health questionnaire-9: exploratory cross-sectional analyses of the baseline health study. BMJ Open. 2022 Jan 4;12(1):e054741. doi: 10.1136/bmjopen-2021-054741.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Health Study; Baseline; Project Baseline; Baseline Study; Project Baseline Study; Baseline Health Study
• Other Study ID Numbers: 2017-BL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is envisioned that the Baseline Study data will be available to qualified researchers for exploratory analysis in the future. Qualified external researchers may apply through applications reviewed by the Proposal Review and Publications Committee and Scientific Executive Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No