A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial.

BACKGROUND: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. OBJECTIVE: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA1c) and in improving secondary clinical, physiological, and behavioral outcomes. METHODS: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA1c levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. RESULTS: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA1c levels compared to the control group (β=-0.05, 95% CI -0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=-0.04, 95% CI -0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention's dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. CONCLUSIONS: While PREDIABETEXT did not significantly improve HbA1c levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3390/ijerph192214706.