mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II Study) (preDIABETEXT)

Development and Evaluation of a Low Intensity, Multifaceted, Digital Health Intervention to Prevent Type 2 Diabetes Mellitus in the Primary Care Setting: the PREDIABETEXT Study

The aim of this study is to develop and evaluate a low intensity, multifaceted, digital health intervention to prevent T2DM based on: i) the use of a system comprising mobile health (mHealth) technology integrated with electronic health records to send tailored text messages (SMSs) promoting lifestyle changes in people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management.

The PREDIABETEXT project will involve five WorkPackages (WP). In WP1-4 we will develop and pilot-test the different components of the intervention (WP1 will develop the brief text messages targeted to patients; WP2 will adapt our existing technology system to deliver the messages; WP3 will develop an educational intervention targeted to Primary Healthcare workers, and; WP4 will pilot-test and optimise both interventions). In WP5 we will conduct a phase II, six-month, three-arm, cluster randomised, clinical trial with 42 primary care workers and 420 patients at risk of T2DM (HbA1c from 6% to 6.4% or fasting plasma glucose 110-125mg/dl, or both) registered in Primary Care centres from Mallorca. Patients will be allocated to a control (usual care) group, intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare workers). The primary outcome will be HbA1c. Secondary outcomes will include additional clinical outcomes, and physiological, behavioural and psychological outcomes.

Participants will receive messaging intervention plus online education to their primary healthcare workers

Participants will receive usual care only, and their healthcare workers will not receive online education

Primary healthcare workers will receive an online educacion about prediabetes. This intervention will aim at: 1) raising awareness about the importance of T2DM prevention; 2) increasing knowledge about effective strategies for diabetes prevention; 3) improving knowledge about brief counselling techniques; and, 4) enhancing communication skills.

Cardiovascular disease risk determined using the REGICOR calculator (www.imim.cat; Ramos et al., 2003)

On a scale from 0 to 7, this questionnaire meassures the level of motivation that participants present for following a healthy diet and a physical activity plan.

Adherence to healthy diet. The score ranges from 0 to 14. A higher score corresponds to a higher adherence to Mediterranean diet. We will classify participants as low adherents (≤5), moderate adherents (6-9) or high adherents (≥10).

The questionnaire is a reliable and valid method to estimate moderate and vigorous intensity leisure time physical activity and sensitive to detect changes in moderate and vigorous intensity leisure time physical activity https://regicor.cat/aplicacions/activitat-fisica/

Spanish version of the physical activity questionnaire used in the Physical activity questionnaire from the Nurses' Health Study

We will use the second part of the questionnaire, which studies sedentary behaviour. It includes questions about the number of hours spent in sedentary activities. Public Health Nutrition: 8(7), 920-927 https://nurseshealthstudy.org/

Calcultaion of alcohol consumption in Spanish Standard Drink units (10g per unit) per week. https://www.fisterra.com/herramientas/calcumed/

ELIGIBILITY CRITERIA FOR PRIMARY HEALTHCARE WORKERS: We will include physicians and nurses from primary care centres in Mallorca. We will exclude those anticipating moving to a different centre during the study period. ELIGIBILITY CRITERIA FOR PATIENTS: Inclusion Criteria: Registered in the Public Health Service of the Balearic Islands At risk of T2DM (HbA1c from 6% to 6.4% within the last 3 months or two consecutive values of fasting plasma glucose 110-125mg/dl within the last 12 months, or both) With access to a mobile device able to receive text messages. Exclusion Criteria: People not able to read messages in Spanish Patients with severe mental conditions. Patients on an antidiabetic medication regime Pregnancy: currently or during the previous 12 months People planning to change healthcare centre during the intervention period

Upon a reasonable request, we will grant access to public organizations. The PI of the project will review the requests.

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