Adolescent suicide is a major public health concern and the third leading cause of death among young people worldwide. Schools are widely recognized as effective settings for universal mental health promotion and suicide prevention. This study aims to evaluate the effectiveness of SOM-RIU, a multifaceted school-based intervention involving pupils and gatekeepers (teachers and parents) in preventing suicidal behaviour and promoting adolescent mental health. We will conduct a six-month, two-arm, cluster-randomised controlled trial. We will recruit 2,280 pupils from 114 classrooms in 38 secondary schools across the Balearic Islands (Spain). Eligible pupils will be aged 12–16 and enrolled in the 2nd and 3rd years of compulsory secondary education. Schools will be randomly assigned (1:1) to either the intervention or control group. Schools in the intervention group will implement the SOM-RIU programme, which includes four weekly psychoeducational sessions for pupils, delivered by trained educational psychologists. These sessions focus on mental health literacy, emotional regulation, suicide risk detection and management, and help-seeking strategies. In parallel, gatekeepers (teachers and parents) will receive a digital educational co-intervention consisting in four multimedia modules to strengthen their role in suicide prevention. Schools in the control group will receive a minimal intervention consisting of educational posters on mental health and suicide prevention displayed within school premises. The primary outcome will be suicidal ideation (Paykel Suicide Scale). Secondary outcomes will include suicide attempts, depression symptoms, well-being, self-harm, substance use, internet addiction, bullying, and cognitive disconnection. Teachers and parents will report on suicide-related knowledge, self-efficacy, and student referrals. Data will be collected at baseline and six-month follow-up. Analyses will be conducted using generalized linear mixed models to account for clustering, and multiple imputation will be used for missing data. A qualitative process evaluation will explore implementation, acceptability, and perceived impact of the intervention, while also examining contextual factors and potential mechanisms of action that may have influenced the outcomes. This trial will generate evidence on the effectiveness of multifaceted, school-based suicide prevention interventions for adolescents. If effective, the SOM-RIU programme could serve as a practical model for enhancing mental health support within educational settings in Spain. NCT06996054 (clinicaltrials.gov). Registration date: 2025-05-30.
Background/Objectives: Mobile health (mHealth) interventions can enhance chronic disease management, but their integration into public healthcare systems remains complex. DiabeText is the first SMS-based intervention in Spain delivering personalized diabetes self-management support using electronic health record data. This study explored perceived barriers and facilitators to the implementation of DiabeText in the Spanish public health context from the perspective of key stakeholders. Methods: A qualitative study was conducted using semi-structured interviews with 14 purposively selected stakeholders involved in digital health, diabetes care, data protection, and healthcare management across several Spanish regions. Interviews were thematically analyzed using Braun and Clarke’s approach and guided by the Implementation Research Logic Model. Results: Participants reported several barriers, including concerns regarding data protection, uncertainty about long-term sustainability, insufficient training and engagement of healthcare professionals and low digital literacy among certain patient groups. Facilitators included favorable institutional momentum for digital innovation, funding availability, perceived clinical utility and scalability of DiabeText, and growing patient familiarity with digital tools. Recommended strategies included integration into existing healthcare systems and workflows, professional training and use of familiar communication platforms. Conclusions: Effective implementation of DiabeText requires addressing regulatory, organizational, and equity-related barriers while leveraging institutional support and readiness for innovation. Early involvement of healthcare professionals, robust data governance, and investment in digital literacy are essential to ensure sustainable and equitable adoption. These findings provide actionable insights to support the integration of mHealth tools into chronic disease care in Spain and similar settings.
Polypharmacy is highly prevalent among older adults and is associated with adverse outcomes. While comprehensive medication review is widely promoted to address potentially inappropriate prescribing, it is resource intensive. Focused deprescribing-defined as the targeted withdrawal or dose reduction of specific drug classes-has emerged as a potentially more scalable strategy. This umbrella review synthesised evidence on the effectiveness and safety of drug class-specific focused deprescribing interventions in older adults. We conducted an umbrella review of systematic reviews evaluating focused deprescribing interventions targeting specific pharmacological classes. MEDLINE, Embase, the Cochrane Library and Web of Science were searched from inception to March 2025. Study selection, data extraction and methodological quality assessment (AMSTAR-2) were performed independently by two reviewers. Findings were synthesised narratively by drug class and outcome domain, and overlap was assessed using the Corrected Covered Area. Twenty-seven systematic reviews were included. Most focused on psychotropics, particularly benzodiazepines, and anticholinergics, with fewer assessing antidiabetics or fall-risk increasing drugs. Reductions in medication use were most consistent for benzodiazepines and other psychotropics, especially when interventions included psychotherapy or multifaceted components. Evidence for antidiabetics suggested feasibility and safety, whereas effects on anticholinergics and fall-risk increasing drugs were limited. Clinical outcomes, including mortality, falls and cognition, were inconsistently reported and rarely improved. Most reviews were rated as critically low quality, and certainty of evidence was generally low or very low. Focused deprescribing appears feasible and generally safe for reducing selected potentially inappropriate medications in older adults; however, its clinical benefits are drug class-dependent and remain uncertain.
BACKGROUND AND AIM:Current clinical care may not address behavioural and psychosocial elements which can influence quality of life (QoL) and recurrence risk of people living with and beyond cancer (PLWBC). There is a lack of validated tools to assess diet, lifestyle and mental health in PLWBC. We have developed a screener to identify individuals who may need further support beyond cancer recurrence. The aim is two-fold: 1) validate the screener in PLWBC; and 2) carry out a pilot feasibility study (PFS) to explore the impact of a lifestyle complex intervention (diet, physical activity and mental health components) on the QoL of PLWBC. METHODS:The study will be carried out at the University Hospital Son Espases (Spain) in PLWBC. A face validity study (n = 15) will assess construct interpretation, completion time, and acquiescence of the screener. For construct validity and reproducibility analysis (n = 100), participants will answer the screener together with validated diet, lifestyle, and mental health questionnaires for comparison. Body composition, physical activity, strength and cortisol levels will be assessed using validated instruments. All participants will answer the screener 7-10 days later for reproducibility analysis. Participants will then be randomized (1:1) to the Low Intervention (LI) or the High Intervention (HI) for the PFS study. LI will receive general advice regarding diet, lifestyle and mental health, and HI will receive individual and group sessions with specialised health professionals. Participants will be followed for three months. Primary outcomes include: 1) validity and reproducibility of the screener; and 2) feasibility of a complex intervention to improve QoL of PLWBC. Secondary outcomes include changes in screener answers and body composition. DISCUSSION:A validated screener which detects PLWBC's needs could be used in follow-up care plans. The PFS will inform on the recruitment of participants and identify potential shortfalls of the design and efficacy. TRIAL REGISTRATION:ClinicalTrials.gov NCT06582498.
BACKGROUND:Engaging patients and families has been promoted as a key strategy for improving patient safety of health systems. However, evidence remains scarce on the effectiveness of this approach in primary care. AIM:To assess the combined effectiveness of primary care interventions in randomised controlled trials (RCTs) promoting patient and family engagement in patient safety. DESIGN AND SETTING:A systematic review and meta-analysis. METHOD:The review followed PRISMA and Cochrane guidelines. Five electronic databases (Medline, CINAHL, Embase, Web of Science, CENTRAL) were searched from inception to 18 September 2024 with keywords in four blocks (patient and family engagement; patient safety; primary care; randomised controlled trial). Patient and family engagement levels were appraised. Where appropriate, results were combined into meta-analyses. RESULTS:Of the 19 included records, 12 reported on completed RCTs. Only one intervention integrated patients/families into overall care safety (high engagement); six aimed at enhancing skills and tools (intermediate), and 12 informed patients/families how to engage and prompted them to do it (low). RCTs primarily targeted medication safety, with meta-analyses showing no significant effects on reducing adverse drug events (odds ratio [OR] 0.86, 95% confidence interval [CI] = 0.70 to 1.08) or improving medication appropriateness measured categorically (OR 0.92, 95% CI = 0.76 to 1.13) or continuously (mean difference 0.71, 95% CI = -0.10 to 1.52). Overall risk of bias was low and certainty of evidence very low to moderate. CONCLUSION:Existing randomised controlled evidence on patient and family engagement in primary care remains inconclusive and limited in scope. Future interventions should include higher levels of engagement and address more diverse patient safety outcomes relevant for primary care.
BACKGROUND:Complications arising from uncontrolled type 2 diabetes mellitus (T2DM) pose a significant burden on individuals' wellbeing and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition. AIM:To assess the impact of DiabeText, a new theory-based, patient-centred, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management. DESIGN AND SETTING:A pragmatic, phase-three, 12-month, two-arm randomised clinical trial involving primary care patients with T2DM in the Balearic Islands, Spain, including in urban and rural areas. METHOD:In total, 742 participants with suboptimal glycaemic control (glycated haemoglobin [HbA1c] level >7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. In addition to usual care, the DiabeText group received 167 messages focused on healthy lifestyle and medication adherence. The primary outcome was HbA1c level. Secondary outcomes were: medication possession ratio; health-related quality of life (measured using the EQ-5D-5L questionnaire); diabetes self-efficacy (measured using the Diabetes Self-Efficacy Scale [DSES]); and self-reported adherence to medication, Mediterranean diet (measured using the 14-Item Mediterranean Diet Adherence Screener [MEDAS-14]), and physical activity (measured using the International Physical Activity Questionnaire [IPAQ]). RESULTS:Over the 12-month period, no statistically significant differences in HbA1c were observed between the intervention and the control groups (β = -0.025 [95% confidence interval {CI} = -0.198 to 0.147; P = 0.772]). In comparison with the control group, the DiabeText group showed significant (P<0.05) improvements in self-reported medication adherence (odds ratio = 1.4; 95% CI = 1.0 to 1.9), DSES (Cohen's d = 0.35), and EQ-5D-5L (Cohen's d = 0.18) scores, but not for the rest of the secondary outcomes. CONCLUSION:DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.
Digital lifestyle interventions to prevent type 2 diabetes mellitus (T2DM) have become more common in the past decade, particularly in the United States. However, how their effectiveness compares with interventions delivered in-person remains unclear, partly due to variability in study design, including format and content of the intervention. Understanding the relative impact of these two modalities is critical for informing evidence-based implementation of lifestyle interventions to prevent T2DM in diverse healthcare settings. To compare the effectiveness of digital versus in-person interventions for preventing T2DM. Following Cochrane methodology, a systematic literature review was conducted to identify and synthesize evidence from randomized controlled trials (RCTs). Searches were conducted in EMBASE, MEDLINE, and Cochrane CENTRAL from inception to December 2024. Completed and ongoing RCTs were eligible. There were no language restrictions to the searches, but to be included studies had to be published in English or Spanish. Studies comparing digital and in-person interventions were eligible. Outcomes for inclusion were selected based on a stakeholder consultation, and were classified as critical (such as body mass index and quality of life) or important (namely physical activity level, incidence of T2DM, and cost-effectiveness). Meta-analyses were performed where appropriate, and narrative syntheses were provided for the remaining outcomes. The GRADE approach was used to assess the certainty of evidence. Eight RCTs met the inclusion criteria, including six completed trials with published results and two ongoing trials. The completed trials encompassed a total of 2,450 participants across various healthcare settings. There was considerable methodological variation across trials, which included the format and content of the interventions, the setting where they were delivered and the outcomes definition. At 12 months, digital interventions were associated with significantly greater weight loss than in-person interventions (n= 1459 participants, mean difference: –1.38 kg, 95% confidence interval [CI] –2.34 to –0.43), with moderate certainty of evidence. At shorter (3 and 6 months) and longer (15-18 months) time points, no relevant differences were observed for weight, body mass index, or glycosylated hemoglobin levels between the modalities, with the certainty of evidence rated as very low to low. Evidence about cost-effectiveness was scarce. No trials evaluated key outcomes such as quality of life or incidence of T2DM. For adverse events, no significant differences were found between modalities (incidence risk ratio: 1.06, 95% CI: 0.45 to 2.50). This systematic literature review highlights that while digital and in-person interventions can both be effective for T2DM prevention, their relative benefits are still unclear. The limited certainty of evidence and the dearth of critical outcomes, such as T2DM incidence, underscore the need for further well-designed RCTs. Future research should prioritize equivalence in intervention intensity, longer follow-up durations, and standardized reporting of outcomes to better inform public health decision-making.
Introductioni) 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.MethodsWe 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).ResultsThe 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.ConclusionsThe PREDIABETEX trial successfully recruited a representative sample of patients at risk of type 2 diabetes and their healthcare providers.
BACKGROUND:Type 2 diabetes (T2D) is a global health concern affecting 10.5% of the adult population and is projected to rise significantly in the coming decades. Lifestyle modification programs, such as the Diabetes Prevention Program (DPP), can effectively reduce T2D risk among individuals with prediabetes. However, their implementation in real-world healthcare settings remains poor, particularly in Spain, where T2D prevalence is the highest in Europe. The ALADIM study aims to evaluate the effectiveness and implementation of an adapted DPP in Spanish Primary Care Centers (PCCs). The primary effectiveness outcome is weight, the co-primary implementation outcome is implementation fidelity. We will also assess the effect of DPP implementation on overall prediabetes management within the PCCs (spillover) by measuring the percentage of people with prediabetes receiving lifestyle advice. METHODS:The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled trial involving 10 PCCs of Mallorca (Balearic Islands, Spain). PCCs will be randomized to the intervention (5 PCCs) or control (5 PCCs) group in a 1:1 ratio. The intervention group will receive training and materials to implement and deliver the adapted DPP over 12 months. The control group will continue providing usual care. The DPP will be culturally adapted using the Intervention Mapping-ADAPT (IM-ADAPT) approach. The implementation strategy will be designed using Implementation Mapping. Measures of effectiveness will be assessed at the participant level at baseline, 6 and 12 months during the intervention period, and 18 months after baseline. Implementation outcomes will be assessed at the PCC level at multiple time-points throughout the study period. Spillover will be assessed at PCC level at months -1, 6 and 18. An intention-to-treat analysis will assess effectiveness and spillover effect using generalized estimating equations. Implementation outcomes will be evaluated using a mixed-methods approach. DISCUSSION:The ALADIM study has the potential to address the gap between research and practice by employing implementation science for evaluation, adaptation and implementation of an evidence-based diabetes intervention. The findings will contribute to the development of a sustainable and scalable implementation strategy for T2D prevention, with potential implications for policy and practice at regional and national levels. TRIAL REGISTRATION:ClinicalTrials.gov, NCT06871059. Registered 10 March 2025, https://clinicaltrials.gov/study/NCT06871059.
Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6–6.4%, and/or fasting plasma glucose 110–125 mg/dL). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted at professionals and delivered as an online training course, and behavioral intervention targeted at individuals at risk of T2DM and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed, and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Individuals at risk of T2DM, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and people at risk of T2DM that will inform the user-centered design of the PREDIABETEXT intervention.
[This corrects the article DOI: 10.3389/fendo.2025.1524336.].
BackgroundThe 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. ObjectiveThis 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. MethodsWe 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. ResultsIn 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. ConclusionsWhile 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 RegistrationClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625 International Registered Report Identifier (IRRID)RR2-10.3390/ijerph192214706
Patient safety, defined by the WHO as the absence of preventable harm, is a critical component of healthcare quality and poses a significant challenge globally. This study aimed to evaluate the effectiveness of SinergiAPS, a patient-centred audit and feedback intervention, in improving patient safety in primary healthcare (PHC) centres. We conducted a 12-month cluster randomized controlled, multicentre trial. Fifty-nine PHC centres (1053 PHC professionals) in Spain were recruited and randomly allocated (1:1) to usual care or SinergiAPS intervention. The SinergiAPS intervention comprised: a bespoke feedback report with results from audits of patient safety based on the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire, administered to 75 patients/centre; a set of educational materials, and a structured template to record safety improvement plans. The primary outcome (at the PHC professional level) was patient safety culture (Medical Office Survey on Patient Safety Culture (MOSPSC) questionnaire). Secondary outcomes (at the centre level) were patient-reported safety (six PREOS-PC scales), and rate of avoidable hospital admissions. After a 12-month follow-up, we conducted 15 semi-structured interviews with PHC professionals to explore their perceptions of the intervention. During the 12-month follow-up, 10 of the 30 centres in the intervention group held action plan team meetings and eight registered 57 safety improvement action plans. The plans aimed to improve patient activation, address treatment-related incidents, enhance communication between patients and providers, and strengthen patient safety culture. At 12 months, no significant differences were observed in MOSPSC mean score (intervention: 3.60 [95
OBJECTIVES:There are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument. DESIGN:A scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged. SETTING:Four countries (Spain, UK, USA and Portugal). PARTICIPANTS:Experts working in a cancer-related health profession or cancer-related research were recruited. MAIN OUTCOME MEASURES:Items were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting. RESULTS:A total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress. CONCLUSIONS:We identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.
Background: Digital and in–person lifestyle interventions to prevent type 2 diabetes (T2DM) are being increasingly implemented in some countries, particularly in the United States. However, their comparative effectiveness remains unclear, partly due to variability in intervention designs and limited robust evidence from randomized controlled trials (RCTs). Understanding their relative impacts is critical for informing evidence-based implementation in diverse healthcare settings. Aim: To compare the effectiveness of digital versus in–person interventions for preventing T2DM. Methods: We conducted a systematic literature review, following Cochrane methodology to identify and synthesize evidence from RCTs. Searches were conducted in EMBASE, MEDLINE, and Cochrane CENTRAL from inception to December 2024, including completed and ongoing trials published in English or Spanish. Studies comparing purely digital and in–person interventions were eligible. Meta–analyses were performed where appropriate, and narrative syntheses were provided for remaining outcomes. The GRADE approach was used to assess the certainty of evidence. Results: Eight RCTs met the inclusion criteria, including six completed trials with published results and two ongoing trials. The completed trials encompassed a total of 2,450 participants across various healthcare settings. At 12 months, digital interventions were associated with significantly greater weight loss than in-person interventions (mean difference: –1.38 kg [95% CI: –2.34 to –0.43]), with moderate certainty of evidence. At shorter (3 and 6 months) and longer (>12 months) time points, no relevant differences were observed for weight, body mass index, or glycosylated haemoglobin levels between the modalities, with the certainty of evidence rated as low to very low. Evidence about cost–effectiveness was scarce. No trials evaluated key outcomes such as incidence of T2DM or health-related quality. For adverse events, no significant differences were found between modalities (RR: 1.06 [95% CI: 0.45 to 2.50]). Conclusions: This systematic review highlights that while digital and in–person interventions can both be effective for T2DM prevention, their relative benefits depend on follow–up duration and contextual factors. The limited certainty of evidence and the absence of trials addressing critical outcomes, such as T2DM incidence, underscore the need for further well–designed RCTs. Future research should prioritize equivalence in intervention intensity, longer follow–up durations, and standardized reporting of outcomes to better inform public health decision–making. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement IRC is funded by Instituto de Salud Carlos III, grant number CP17/00017. RZC was funded by Instituto de Investigacion Sanitaria de las Islas Baleares, grant number FOLIUM–2023 (founded by ITS2023/057). The rest of the authors are not funded by any grant or award to develop this work. The funders had no role in study design nor preparation of the protocol. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study used openly available human data that were originally located at: 1. Abusamaan, M.S., et al., Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial. Trials, 2024. 25(1): p. 325. 2. Almeida, F.A., et al., Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol. Contemporary clinical trials, 2020. 88: p. 105877. 3. Almeida, F.A., et al., Design and methods of "diaBEAT-it!": a hybrid preference/randomized control trial design using the RE-AIM framework. Contemporary clinical trials, 2014. 38(2): p. 383-96. 4. Almeida, F.A., et al., A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study. Frontiers in public health, 2023. 11: p. 1000162. 5. Beasley, J.M., et al., Study protocol: BRInging the Diabetes prevention program to GEriatric Populations. Frontiers in medicine, 2023. 10: p. 1144156. 6. Ferrara, A., et al., Comparative Effectiveness of 2 Diabetes Prevention Lifestyle Programs in the Workplace: The City and County of San Francisco Diabetes Prevention Trial. Preventing chronic disease, 2020. 17: p. E38. 7. Katula, J.A., et al., Effects of a Digital Diabetes Prevention Program: An RCT. American journal of preventive medicine, 2022. 62(4): p. 567-577. 8. Ma, J., et al., Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA internal medicine, 2013. 173(2): p. 113-21. 9. Michaud, T.L., et al., Effects of a digital diabetes prevention program on cardiovascular risk among individuals with prediabetes. Primary care diabetes, 2023. 17(2): p. 148-154. 10. Michaud, T.L., et al., Cost and cost-effectiveness analysis of a digital diabetes prevention program: results from the PREDICTS trial. Translational behavioral medicine, 2023. 13(7): p. 501-510. 11. Moravcova, K., et al., Comparing the Efficacy of Digital and In-Person Weight Loss Interventions for Patients with Obesity and Glycemic Disorders: Evidence from a Randomized Non-Inferiority Trial. Nutrients, 2024. 16(10). 12. Nct, Preventing Diabetes With Digital Health and Coaching. https://clinicaltrials.gov/show/[NCT03312764][1], 2017. 13. Nct, Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs. https://clinicaltrials.gov/ct2/show/[NCT05056376][2], 2021. 14. Padilla, H.M., et al., Reach, Uptake, and Satisfaction of Three Delivery Modes of FUEL Your Life. Health promotion practice, 2021. 22(3): p. 415-422. 15. Park, S., et al., Cost-effectiveness analysis of a digital Diabetes Prevention Program (dDPP) in prediabetic patients. Journal of telemedicine and telecare, 2023: p. 1357633X231174262. 16. Wilson, M.G., et al., Effect of Intensity and Program Delivery on the Translation of Diabetes Prevention Program to Worksites: A Randomized Controlled Trial of Fuel Your Life. Journal of occupational and environmental medicine, 2016. 58(11): p. 1113-1120. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data that support the findings of this study are available from the corresponding author, IRC, upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03312764&atom=%2Fmedrxiv%2Fearly%2F2025%2F01%2F25%2F2025.01.23.25321002.atom [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05056376&atom=%2Fmedrxiv%2Fearly%2F2025%2F01%2F25%2F2025.01.23.25321002.atom
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. 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. 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. 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. 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. ClinicalTrials.gov. NCT05110625 RR2-doi: 10.3390/ijerph192214706
Antibiotic overprescription is a complex global problem that contributes to antibacterial resistance. Enhancing professionals’ communication skills is one of the most promising interventions for optimising antibiotic prescription in respiratory tract infections in children. We developed a communication skills course for primary care paediatricians, paediatric nurses and community pharmacists. We conducted: 1) A scoping review, 2) brainstorming and selection of themes, 3) design of content, 4) user testing, through a survey and semi-structured interviews. A multidisciplinary advisory group gave feedback throughout the design and development process. We conducted a descriptive analysis of the survey results, and we used a predefined analytical framework for qualitative content. The course comprised four modules with nineteen themes, which included communication theoretical content, clinical cases, complementary reading, videos, and a glossary. It also included a forum and webinars, after each module. Sixteen users completed several themes and a survey, and eight were interviewed. They rated a mean of 4 or higher (5-point scale), across most of the domains evaluated. The videos received the highest rating (4.81; SD = 0.39). Suggestions for improvement included incorporating a workshop, and featuring more representation of other professionals. The majority of professionals (93
Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6%-6.4%, and/or fasting plasma glucose 110-125 mg/dl). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted to professionals and delivered as an online training course, and; behavioral intervention targeted to patients and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Patients, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and patients that will inform the user-centered design of the PREDIABETEXT intervention.
To inform the clinical practice guidelines' recommendations developed by the European Academy of Allergy and Clinical Immunology systematic reviews (SR) assessed using GRADE on the impact of environmental tobacco smoke (ETS) and active smoking on the risk of new-onset asthma/recurrent wheezing (RW)/low lung function (LF), and on asthma-related outcomes. Only longitudinal studies were included, almost all on combustion cigarettes, only one assessing e-cigarettes and LF. According to the first SR (67 studies), prenatal ETS increases the risk of RW (moderate certainty evidence) and may increase the risk of new-onset asthma and of low LF (low certainty evidence). Postnatal ETS increases the risk of new-onset asthma and of RW (moderate certainty evidence) and may impact LF (low certainty evidence). Combined in utero and postnatal ETS may increase the risk of new-onset asthma (low certainty evidence) and increases the risk of RW (moderate certainty evidence). According to the second SR (24 studies), ETS increases the risk of severe asthma exacerbations and impairs asthma control and LF (moderate certainty evidence). According to the third SR (25 studies), active smoking increases the risk of severe asthma exacerbations and of suboptimal asthma control (moderate certainty evidence) and may impact asthma-related quality-of-life and LF (low certainty evidence).