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. 2025 Mar 31:16:1524336.
doi: 10.3389/fendo.2025.1524336. eCollection 2025.

Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants' baseline characteristics of the PREDIABETEXT trial

Sofía Mira-Martínez  1   2   3 , Rocío Zamanillo-Campos  1   2   3 , Narges Malih  1   2   3 , Maria Antonia Fiol-deRoque  1   2   3   4 , Escarlata Angullo-Martínez  3 , Rafael Jimenez  5   6 , Maria Jesús Serrano-Ripoll  1   2   3   4 , Alfonso Leiva  1   2   3   4 , José Iván Oña  7 , Aina M Galmes-Panades  8   9   10 , Miquel Bennasar-Veny  1   11   12 , Aina Maria Yañez  1   11 , Rocío Gómez-Juanes  1   4   13   14 , Jadwiga Konieczna  10   15 , Jerónima Miralles  1   3 , Dora Romaguera  12   15 , María Clara Vidal-Thomasa  1   2   3 , Joan Llobera-Canaves  1   2   3   4 , Mauro García-Toro  1   4   13   14 , Elena Gervilla-García  5   6 , Catalina Vicens  1   14   16 , Oana Bulilete  1   2   3   4 , Juan José Montaño  5   6 , Margalida Gili  1   4   13   14 , Miquel Roca  1   13   14 , Antoni Colom  15   17 , Ignacio Ricci-Cabello  1   2   3   12
Affiliations

Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants' baseline characteristics of the PREDIABETEXT trial

Sofía Mira-Martínez et al. Front Endocrinol (Lausanne). .

Erratum in

Abstract

Introduction: i) to describe PREDIABETEXT, a novel digital intervention for the prevention of type 2 diabetes; ii) to examine the performance of a strategy for virtual recruitment of participants in a trial to assess its impact, and; iii) to determine the baseline characteristics of the enrolled participants.

Methods: We developed PREDIABETEXT in a multistage process involving systematic literature reviews and qualitative research with end users (primary care patients and professionals). We combined multiple virtual strategies (SMS, phone calls, promotional videos) to recruit healthcare professionals and their patients. We collected baseline data from patients (sociodemographic, behavioral and clinical) and healthcare professionals (sociodemographic and professional experience).

Results: The intervention consisted in delivering personalized short text messages supporting lifestyle behavior changes to people at risk of type 2 diabetes; and online training to their primary healthcare professionals. We recruited 58/133 (43.6%) professionals (30 doctors; 28 nurses) from 16 centers. Most professionals (83%) were women [mean (SD) age 49.69 (10.15)]. We recruited 365/976 (37.4%) patients (54.5% women, 59.82 (9.77) years old. Around half (55.3%) presented obesity (BMI ≥25), 65% hypertension, 43.3% hypercholesterolemia, and 14.8% hypertriglyceridemia.

Conclusions: The PREDIABETEX trial successfully recruited a representative sample of patients at risk of type 2 diabetes and their healthcare providers.

Keywords: clinical trial; patient recruitment; prediabetic state; preventive health services; primary health care.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Participant flow diagram from enrolment to randomization.
See this image and copyright information in PMC

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