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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

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  • 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
    Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain
    Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), 07120 Palma, Spain
    The authors contributed equally to this work.)

  • Escarlata Angullo

    (Escola Graduada Primary Health Care Center, Balearic Health Service, 07002 Palma de Mallorca, Spain
    Research Group on Community Nutrition & Oxidative Stress, University of Balearic Islands-IUNICS, IDISBA & CIBEROBN (Physiopathology of Obesity and Nutrition), 07120 Palma de Mallorca, Spain
    The authors contributed equally to this work.)

  • Sofía Mira-Martínez

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 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
    Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), 07120 Palma, Spain
    Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain
    CIBER de Epidemiología y Salud Pública (CIBERESP), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Rocío Zamanillo-Campos

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain)

  • Rocío Gómez-Juanes

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain
    Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain)

  • Jadwiga Konieczna

    (Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain
    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)

  • Rafael Jiménez

    (Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
    Department of Psychology, University of the Balearic Islands (UIB), 07120 Palma, Spain)

  • Maria Jesús Serrano-Ripoll

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Maria Antonia Fiol-deRoque

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain)

  • Jerónima Miralles

    (Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 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
    Department of Nursing and Physiotherapy, University of the Balearic Islands (UIB), 07120 Palma, Spain
    Research Group on Global Health and Human Development, University of the Balearic Islands (UIB), 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
    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)

  • Maria Clara Vidal-Thomas

    (Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain)

  • Joan Llobera-Canaves

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Mauro García-Toro

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain
    Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Catalina Vicens

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain
    Son Serra-La Vileta Primary Health Care Center, Balearic Health Service, 07013 Palma, Spain)

  • Elena Gervilla-García

    (Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
    Department of Psychology, University of the Balearic Islands (UIB), 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
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Oana Bulilete

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Juan José Montaño

    (Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
    Department of Psychology, University of the Balearic Islands (UIB), 07120 Palma, Spain)

  • Margalida Gili

    (Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain
    Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain
    Statistical and Psychometric Procedures Applied in Health Sciences (PSICOMEST), Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Miquel Roca

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07120 Palma de Mallorca, Spain
    Department of Medicine, University of the Balearic Islands, 07122 Palma, Spain
    Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), Institute of Health Carlos III, 28029 Madrid, Spain)

  • Ignacio Ricci-Cabello

    (Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain
    Research Group in Primary Care and Promotion—Balearic Islands Community (GRAPP-caIB), 07120 Palma de Mallorca, Spain
    Primary Care Research Unit of Mallorca (IB-Salut), Balearic Health Service, 07002 Palma de Mallorca, Spain
    CIBER de Epidemiología y Salud Pública (CIBERESP), Institute of Health Carlos III, 28029 Madrid, Spain)

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.

Suggested Citation

  • 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 , 2022. "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," IJERPH, MDPI, vol. 19(22), pages 1-17, November.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:22:p:14706-:d:967411
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    as
    1. Rocío Zamanillo-Campos & Maria Jesús Serrano-Ripoll & Joana Maria Taltavull-Aparicio & Elena Gervilla-García & Joana Ripoll & Maria Antonia Fiol-deRoque & Anne-Marie Boylan & Ignacio Ricci-Cabello, 2022. "Patients’ Views on the Design of DiabeText, a New mHealth Intervention to Improve Adherence to Oral Antidiabetes Medication in Spain: A Qualitative Study," IJERPH, MDPI, vol. 19(3), pages 1-14, February.
    2. Royston, Patrick & White, Ian R., 2011. "Multiple Imputation by Chained Equations (MICE): Implementation in Stata," Journal of Statistical Software, Foundation for Open Access Statistics, vol. 45(i04).
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