Harris, Alexandra
Jordan, Neil
Carroll, Allison J.
Graham, Andrea K.
Wilson, Charlton
Wilson, Fernando A.
Berkel, Cady
Smith, Justin D. http://orcid.org/0000-0003-3264-8082
Funding for this research was provided by:
National Center for Chronic Disease Prevention and Health Promotion (U18DP006255)
Article History
Received: 16 August 2022
Accepted: 16 April 2023
First Online: 5 June 2023
Declarations
:
: The trial is designed in accordance with the basic ethical principles of autonomy, beneficence, justice, and non-maleficence and will be conducted in accordance with the rules of Good Clinical Practice outlined in the most recent Declaration of Helsinki. Written informed consent of patients will be required. Data confidentiality and anonymity will be ensured, according to the provisions of US law, both during the implementation phase of the study and in any resulting presentations or publications. The study has been favorably evaluated by the Institutional Review Board of Arizona State University on July 14, 2016 (Protocol 00004530) and by the Institutional Review Board of the Phoenix Children’s Hospital on May 30, 2017 (Protocol 17–001). All other institutions participating in this research provided signed reliance agreements ceding to the Institutional Review Board of Arizona State University. The informed consent completed by the participants of this trial is provided as an Additional file InternalRef removed in the trial Protocol Paper (Smith et al., 2018, <i>Implement Sci</i>).
: Not applicable.
: JDS and CB are co-developers of the FCU4Health program.