Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes.

Autor: Berube LT; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA. Lauren.Thomas@nyulangone.org.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA. Lauren.Thomas@nyulangone.org., Popp CJ; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Curran M; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Hu L; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Pompeii ML; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Barua S; Division of Precision Medicine, Department of Medicine, New York University Langone Health, New York, NY, USA., Bernstein E; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Salcedo V; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Li H; Division of Biostatistics, Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., St-Jules DE; Department of Nutrition, University of Nevada, Reno, 1664 N. Virginia Street, Reno, NV, 89557, USA., Segal E; Department of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel., Bergman M; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Medicine, New York University Langone Health, New York, NY, USA.; Holman Division of Endocrinology, Diabetes and Metabolism, Manhattan VA Medical Center, 423 East 23rd Street, New York, NY, 10010, USA., Williams NJ; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA., Sevick MA; Center for Healthful Behavior Change, Institute for Excellence in Health Equity, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Population Health, New York University Langone Health, 180 Madison Ave, New York, NY, 10016, USA.; Department of Medicine, New York University Langone Health, New York, NY, USA.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Jul 25; Vol. 25 (1), pp. 506. Date of Electronic Publication: 2024 Jul 25.
DOI: 10.1186/s13063-024-08337-w
Abstrakt: Background: The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE).
Methods: Eligible participants are between 21 and 80 years of age diagnosed with moderately controlled T2D (HbA1c: 6.0 to 8.0%) and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: (1) Personalized, (2) Standardized, or (3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrient targets to meet Mediterranean diet guidelines, in addition to 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same educational content as those in the UCC arm, following the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, in addition to real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app.
Discussion: The DiaTeleMed Study aims to address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level.
Trial Registration: ClinicalTrials.gov NCT05046886. Registered on September 16, 2021.
(© 2024. The Author(s).)
Databáze: MEDLINE
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