Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact 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

Narges Malih ^1* Sofía Mira-Martínez ² Rocío Zamanillo-Campos ² Maria A. Fiol-deRoque ² Escarlata Angullo ² Rafael Jiménez ^1,2 Maria J Serrano-Ripoll ² Alfonso Leiva ^2,3 José Iván Oña ⁴ Aina M Galmes-Panades ^1,2 Miquel Bennasar-Veny ¹ Aina Maria Yañez ¹ Rocío Gómez-Juanes ² Jadwiga Konieczna ² Jerónima Miralles ² Dora Romaguera ² M Clara Vidal-Thomàs ² Joan Llobera-Canaves ² Mauro Garcia-Toro ² Elena Gervilla ² Catalina Vicens ² Oana Bulilete ² Juan José Montaño ² Margalida Gili ² Miquel Roca ² Ignacio Ricci-Cabello ²

• ¹ University of the Balearic Islands, Palma de Mallorca, Spain
• ² Balearic Islands Health Research Institute (IdISBa), Palma de Mallorca, Balearic Islands, Spain
• ³ Research Network on Chronicity, Primary Care and Health Promotion (RICAPPS), Barcelona, Balearic Islands, Spain
• ⁴ Balearic Public Health Service, Palma, Spain

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.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, behavioural and clinical) and healthcare professionals (sociodemographic and professional experience).The intervention consisted in delivering personalized short text messages supporting lifestyle behaviour 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 centres. 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.The PREDIABETEX trial successfully recruited a representative sample of patients at risk of type 2 diabetes and their healthcare providers.