Clinical trial NCT03154346: Project Baseline Health Study
Official title: Project Baseline Health Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: All
Keywords: Baseline
Project Baseline
Baseline Study
Project Baseline Study
Health Study
Baseline Health Study
Lead sponsor: Baseline Study LLC
Sponsor class: INDUSTRY
Collaborators: name: Verily Life Sciences LLC
name: Duke University
name: Stanford University
name: Google LLC.
First posted: 2017-05-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: For the duration of the study
measure: Evaluate the use of sensor technologies for the collection of continuous, accurate health information
timeFrame: For the duration of the study
measure: Create a dataset encompassing a wide spectrum of phenotypic measures for future exploratory analysis
timeFrame: For the duration of the study
measure: Measure the phenotypic diversity observed among a participant population, defining a range of expected values for multiple types of data
timeFrame: For the duration of the study
measure: Identify biomarkers of disease-related transitions, including those related to cardiovascular disease and cancer
timeFrame: For the duration of the study
Secondary outcomes:
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Baseline Study
state: California
city: Stanford
country: United States
facility: Stanford Medicine
state: California
city: Westlake Village
country: United States
facility: California Health and Longevity Institute
state: California
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Kannapolis
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.