Effectiveness of PREDIABETEXT, a multifaceted digital intervention for the prevention of type 2 diabetes mellitus: findings from a pragmatic cluster randomized controlled trial in the primary care setting in Spain (Preprint)

• DOI: 10.2196/preprints.70981
• Publication Date: 2025-01-08T03:06:09Z
• Authors: Sofía Mira-Martínez; Narges Malih; Escarlata Angullo...; Rocío Zamanillo-C...; Aina M. Yañez; Miquel Bennasar-Veny; Rocío Gómez-Juanes; Jadwiga Konieczna; Rafael Jiménez; Maria Jesús Serra...; Maria Antonia Fio...; Aina M. Galmes-Pa...; Jerónima Miralles; Maria Clara Vidal...; Cristina Gómez-Cobo; Elena Gervilla-Ga...; José Iván Oña; Ignacio Ricci-Cab...

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 is still in its early stages.

OBJECTIVE This study aimed to address this gap by evaluating the impact of PREDIABETEXT, a digital health intervention, on glycated haemoglobin (HbA1c) and other secondary clinical, physiological and behavioral measures.

METHODS We conducted a six-month, three-arm pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA1c between 6.0% and 6.4% in the last three months and/or two 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 3–5 personalized short-text messages per week aimed at supporting lifestyle behavior changes and online training for their primary healthcare professionals. A total of 58 professionals (clusters) from 16 centers participated in the study, and they were randomized (1:1:1) to Intervention A (patient text messaging intervention), Intervention B (patient text messaging + provider online training), or the control group (usual care). Following the six-month follow-up, we conducted individual qualitative interviews with eight patients and seven healthcare professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers.

RESULTS We recruited 365 patients: 119 in the control group, 106 in Intervention A, and 140 in Intervention B. Their mean (SD) age was 59.79 (9.75) years, and 54.5% (199) were female. At six months, Intervention A resulted in a small, non-significant reduction in HbA1c compared to the control group (β = -0.05; 95% CI, -0.21 to 0.10, P = 0.50), while Intervention B showed a similar non-significant reduction (β = -0.04; 95% CI, -0.12 to 0.10, P = 0.56). Among secondary outcomes, Intervention A was associated with a significant reduction in REGICOR-Framingham cardiovascular risk scores (β = -1.53; 95% CI, -2.87 to -0.18; P = 0.02). No significant differences were observed in the rest of secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention's dietary messages, frequency, and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Healthcare professionals valued the online training but highlighted time constraints and suggested shorter or blended formats to improve accessibility.

CONCLUSIONS A low-intensity, multifaceted digital intervention did not significantly improve glycemic control in individuals at risk for type 2 diabetes mellitus but did reduce cardiovascular risk. Future studies should explore the potential benefits of higher-intensity, multicomponent digital interventions.

CLINICALTRIAL ClinicalTrials.gov. NCT05110625

INTERNATIONAL REGISTERED REPORT RR2-doi: 10.3390/ijerph192214706