PMID- 36429423 OWN - NLM STAT- MEDLINE DCOM- 20221129 LR - 20230130 IS - 1660-4601 (Electronic) IS - 1661-7827 (Print) IS - 1660-4601 (Linking) VI - 19 IP - 22 DP - 2022 Nov 9 TI - Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial. LID - 10.3390/ijerph192214706 [doi] LID - 14706 AB - BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention. FAU - Galmes-Panades, Aina M AU - Galmes-Panades AM AUID- ORCID: 0000-0001-6977-9874 AD - Global Health and Lifestyle (EVES Group), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma, Spain. AD - Consorcio CIBER, M.P. Fisiopatologia de la Obesidad y Nutricion (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain. AD - Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), 07120 Palma, Spain. FAU - Angullo, Escarlata AU - Angullo E AD - Escola Graduada Primary Health Care Center, Balearic Health Service, 07002 Palma de Mallorca, Spain. AD - Research Group on Community Nutrition & Oxidative Stress, University of Balearic Islands-IUNICS, IDISBA & CIBEROBN (Physiopathology of Obesity and Nutrition), 07120 Palma de Mallorca, Spain. FAU - Mira-Martinez, Sofia AU - Mira-Martinez S AUID- ORCID: 0000-0002-6402-4760 AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. FAU - Bennasar-Veny, Miquel AU - Bennasar-Veny M AUID- ORCID: 0000-0003-1668-2141 AD - Global Health and Lifestyle (EVES Group), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma, Spain. AD - Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), 07120 Palma, Spain. AD - Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain. AD - CIBER de Epidemiologia y Salud Publica (CIBERESP), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Zamanillo-Campos, Rocio AU - Zamanillo-Campos R AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. FAU - Gomez-Juanes, Rocio AU - Gomez-Juanes R AUID- ORCID: 0000-0002-9040-5508 AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain. AD - Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain. FAU - Konieczna, Jadwiga AU - Konieczna J AD - Consorcio CIBER, M.P. Fisiopatologia de la Obesidad y Nutricion (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain. AD - Research Group on Nutritional Epidemiology & Cardiovascular Physiopathology (NUTRECOR), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma de Mallorca, Spain. FAU - Jimenez, Rafael AU - Jimenez R AUID- ORCID: 0000-0002-1181-3221 AD - Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain. AD - Department of Psychology, University of the Balearic Islands (UIB), 07120 Palma, Spain. FAU - Serrano-Ripoll, Maria Jesus AU - Serrano-Ripoll MJ AUID- ORCID: 0000-0002-1869-1132 AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Fiol-deRoque, Maria Antonia AU - Fiol-deRoque MA AUID- ORCID: 0000-0001-8566-0929 AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. FAU - Miralles, Jeronima AU - Miralles J AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. FAU - Yanez, Aina M AU - Yanez AM AUID- ORCID: 0000-0001-8527-3937 AD - Global Health and Lifestyle (EVES Group), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma, Spain. AD - Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), 07120 Palma, Spain. AD - Research Group on Global Health and Human Development, University of the Balearic Islands (UIB), 07120 Palma, Spain. FAU - Romaguera, Dora AU - Romaguera D AUID- ORCID: 0000-0002-5762-8558 AD - Consorcio CIBER, M.P. Fisiopatologia de la Obesidad y Nutricion (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain. AD - Research Group on Nutritional Epidemiology & Cardiovascular Physiopathology (NUTRECOR), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma de Mallorca, Spain. FAU - Vidal-Thomas, Maria Clara AU - Vidal-Thomas MC AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. FAU - Llobera-Canaves, Joan AU - Llobera-Canaves J AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Garcia-Toro, Mauro AU - Garcia-Toro M AUID- ORCID: 0000-0002-2251-1368 AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain. AD - Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Vicens, Catalina AU - Vicens C AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain. AD - Son Serra-La Vileta Primary Health Care Center, Balearic Health Service, 07013 Palma, Spain. FAU - Gervilla-Garcia, Elena AU - Gervilla-Garcia E AUID- ORCID: 0000-0003-3194-5499 AD - Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain. AD - Department of Psychology, University of the Balearic Islands (UIB), 07120 Palma, Spain. FAU - Ona, Jose Ivan AU - Ona JI AD - Dra. Teresa Pique Primary Health Care Center, Balearic Health Service, 07003 Palma, Spain. FAU - Malih, Narges AU - Malih N AUID- ORCID: 0000-0002-5184-0881 AD - Research Group on Global Health and Human Development, University of the Balearic Islands (UIB), 07120 Palma, Spain. FAU - Leiva, Alfonso AU - Leiva A AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Bulilete, Oana AU - Bulilete O AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Montano, Juan Jose AU - Montano JJ AUID- ORCID: 0000-0002-1116-1964 AD - Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain. AD - Department of Psychology, University of the Balearic Islands (UIB), 07120 Palma, Spain. FAU - Gili, Margalida AU - Gili M AD - Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain. AD - Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain. AD - Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Roca, Miquel AU - Roca M AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain. AD - Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain. AD - Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain. FAU - Ricci-Cabello, Ignacio AU - Ricci-Cabello I AD - Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain. AD - Research Group in Primary Care and Promotion-Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain. AD - Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain. AD - CIBER de Epidemiologia y Salud Publica (CIBERESP), Institute of Health Carlos III, 28029 Madrid, Spain. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20221109 PL - Switzerland TA - Int J Environ Res Public Health JT - International journal of environmental research and public health JID - 101238455 SB - IM MH - Humans MH - *Diabetes Mellitus, Type 2/prevention & control MH - *Prediabetic State/therapy MH - Life Style MH - *Text Messaging MH - Primary Health Care MH - Randomized Controlled Trials as Topic MH - Clinical Trials, Phase II as Topic PMC - PMC9690330 OTO - NOTNLM OT - SMS intervention OT - diet advice OT - digital health intervention OT - mHealth OT - nursing OT - physical activity OT - prediabetes OT - prevention OT - type 2 diabetes mellitus COIS- The authors declare no conflict of interest. EDAT- 2022/11/27 06:00 MHDA- 2022/11/30 06:00 PMCR- 2022/11/09 CRDT- 2022/11/26 01:09 PHST- 2022/10/14 00:00 [received] PHST- 2022/11/03 00:00 [revised] PHST- 2022/11/04 00:00 [accepted] PHST- 2022/11/26 01:09 [entrez] PHST- 2022/11/27 06:00 [pubmed] PHST- 2022/11/30 06:00 [medline] PHST- 2022/11/09 00:00 [pmc-release] AID - ijerph192214706 [pii] AID - ijerph-19-14706 [pii] AID - 10.3390/ijerph192214706 [doi] PST - epublish SO - Int J Environ Res Public Health. 2022 Nov 9;19(22):14706. doi: 10.3390/ijerph192214706.