Funding for this research was provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (R18DK109518)
Received: 21 March 2019
Accepted: 30 April 2019
First Online: 17 May 2019
Ethics approval and consent to participate
: This trial was conducted with the approval of the Duke University Campus Institutional Review Board (Protocol #2017–0738/D0479) and the Piedmont Health advisory board. In order to enhance the trial’s pragmatic design, which did not include in-person study visits, and to enroll participants located in remote areas in a timely manner after their initial appointments, verbal informed consent was obtained from all participants, instead of written informed consent. In addition, a written copy of the informed consent form was provided to all participants in the mailed materials after enrollment. This informed consent process had been previously approved by the Duke University Campus Institutional Review Board.
: Gary Bennett holds equity in Coeus Health and serves on the scientific advisory board of Nutrisystem. Dori Steinberg is a consultant with Omada Health. These organizations had no role in study design, data collection, data analysis and interpretation of data, in the writing of the report, or in the decision to submit this article for publication. The remaining authors declare that they have no conflicting interests.
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