Fu, Emily S. https://orcid.org/0000-0002-9070-2975
Merle, James L.
Berkel, Cady https://orcid.org/0000-0001-9664-9485
Brown, C. Hendricks
Philbin, Sarah
Fan, Yiqing
McGinnis, Jenna L.
Demauro, Dania
DiGregorio, Ariana
Litchey, Janeth
Smith, Justin D.
Funding for this research was provided by:
NHLBI Division of Intramural Research (F31HL160534)
U.S. Department of Agriculture (2018-68001-27550)
Centers for Disease Control and Prevention (U18DP006255)
Article History
Received: 20 June 2025
Accepted: 16 January 2026
First Online: 30 January 2026
Declarations
:
: This study was designed in accordance with the basic ethical principles of autonomy, beneficence, justice, and non-maleficence and conducted in accordance with the rules of Good Clinical Practice outlined in the most recent Declaration of Helsinki. The study was approved by the Institutional Review Board (IRB) of Northwestern University (STU00215542). The two FCU4Health trials (ethics approval numbers: STUDY00012412; STUDY00009621) and all procedures were reviewed and approved by the Arizona State University IRB. All other participating institutions provided signed reliance agreements ceding to the IRB of Arizona State University.
: Consent and assent were obtained from all participants included in the study.
: Cady Berkel and Justin D. Smith co-developed the Family Check-Up 4 Health program. The other authors have no potential conflicts of interest to declare.
: This is a secondary analysis using data from the following two clinical trial registration numbers: NCT03013309 ClinicalTrials.gov and NCT04469816 ClinicalTrials.gov.