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

Aina M. Galmes-Panades, Escarlata Angullo, Sofía Mira-Martínez (), Miquel Bennasar-Veny, Rocío Zamanillo-Campos, Rocío Gómez-Juanes, Jadwiga Konieczna, Rafael Jiménez, Maria Jesús Serrano-Ripoll, Maria Antonia Fiol-deRoque, Jerónima Miralles, Aina M. Yañez, Dora Romaguera, Maria Clara Vidal-Thomas, Joan Llobera-Canaves, Mauro García-Toro, Catalina Vicens, Elena Gervilla-García, José Iván Oña, Narges Malih, Alfonso Leiva, Oana Bulilete, Juan José Montaño, Margalida Gili, Miquel Roca and Ignacio Ricci-Cabello
Additional contact information
Aina M. Galmes-Panades: Global Health and Lifestyle (EVES Group), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma, Spain
Escarlata Angullo: Escola Graduada Primary Health Care Center, Balearic Health Service, 07002 Palma de Mallorca, Spain
Sofía Mira-Martínez: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Miquel Bennasar-Veny: Global Health and Lifestyle (EVES Group), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma, Spain
Rocío Zamanillo-Campos: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Rocío Gómez-Juanes: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Jadwiga Konieczna: Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain
Rafael Jiménez: Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
Maria Jesús Serrano-Ripoll: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Maria Antonia Fiol-deRoque: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Jerónima Miralles: Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
Aina M. Yañez: Global Health and Lifestyle (EVES Group), Health Research Institute of the Balearic Islands (IdISBa), University Hospital Son Espases (HUSE), 07120 Palma, Spain
Dora Romaguera: Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain
Maria Clara Vidal-Thomas: Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
Joan Llobera-Canaves: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Mauro García-Toro: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Catalina Vicens: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Elena Gervilla-García: Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
José Iván Oña: Dra. Teresa Piqué Primary Health Care Center, Balearic Health Service, 07003 Palma, Spain
Narges Malih: Research Group on Global Health and Human Development, University of the Balearic Islands (UIB), 07120 Palma, Spain
Alfonso Leiva: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Oana Bulilete: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Juan José Montaño: Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
Margalida Gili: Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain
Miquel Roca: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
Ignacio Ricci-Cabello: Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain

IJERPH, 2022, vol. 19, issue 22, 1-17

Abstract: 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.

Keywords: prediabetes; mHealth; digital health intervention; SMS intervention; nursing; diet advice; physical activity; prevention; type 2 diabetes mellitus (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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