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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention A | Experimental | Participants will receive Messaging Intervention |
|
| Intervention B | Experimental | Participants will receive messaging intervention plus online education to their primary healthcare workers |
|
| Control | No Intervention | Participants will receive usual care only, and their healthcare workers will not receive online education |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preDIABE-TEXT | Behavioral | Participants will receive text messages (three per week) in their mobile phones during six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months | Baseline and Postintervention (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Fasting blood glucose at 6 months | Baseline and Postintervention (6 months) | |
| Change from Baseline Triglycerides at 6 months | Baseline and Postintervention (6 months) | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of eligible patients | Baseline | |
| Recruitment rate | follow-up rate | Baseline |
| Follow-up rate |
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ignacio Ricci-Cabello | Palma de Mallorca | Balearic Islands | 07002 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21987347 | Background | Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11. | |
| 26393848 |
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We will share all collected IPD after anonymization
Data will be available from January 2023 onwards
Upon a reasonable request, we will grant access to public organizations. The PI of the project will review the requests.
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Online Education | Other | 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. |
|
| Change from Baseline Total Cholesterol at 6 months |
| Baseline and Postintervention (6 months) |
| Change from Baseline low density cholesterol (LDL) at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline high density cholesterol (HDL) at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline lipoprotein A at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline aspartate aminotransferase enzyme (AST) at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline alanine aminotransferase (ALT) at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline gamma glutamil transpeptidase (GGT) at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline complete hemogram at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline creatinine at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline serum albumin at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline insuline at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline urinary sediment at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline albumin-craetinine ratio at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline Body Weight at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline Waist Circumference at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline Blood Pressure at 6 months | Baseline and Postintervention (6 months) |
| Change from Baseline of Cardiovascular disease risk at 6 months | Cardiovascular disease risk determined using the REGICOR calculator (www.imim.cat; Ramos et al., 2003) | Baseline and Postintervention (6 months) |
| Diagnosis of T2DM | Postintervention (6 months) |
| Brief motivation questionnaire (ad hoc) | 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. | Baseline and Postintervention (6 months) |
| 14-point Mediterranean diet adherence screener (MEDAS-14) | 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). | Baseline and Postintervention (6 months) |
| REGICOR Short form Physical Activity Questionnaire | 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/ | Baseline and Postintervention (6 months) |
| 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/ | Baseline and Postintervention (6 months) |
| Global Adult Tobbacco Survey: GATS questionnaire. | Tobbacco consumption. 3-items adapted from the GATS questionnaire (WHO). | Baseline and Postintervention (6 months) |
| Quantification of alcohol consumption - FISTERRA | Calcultaion of alcohol consumption in Spanish Standard Drink units (10g per unit) per week. | Baseline and Postintervention (6 months) |
| Postintervention (6 months) |
| Background |
| Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945. |
| 41067715 | Derived | Mira-Martinez S, Malih N, Angullo-Martinez E, Zamanillo-Campos R, Yanez AM, Bennasar-Veny M, Gomez-Juanes R, Konieczna J, Jimenez R, Serrano-Ripoll MJ, Fiol-deRoque MA, Leiva A, Galmes-Panades AM, Miralles-Xamena J, Vidal-Thomas MC, Gomez-Cobo C, Gervilla E, Ona-Gil JI, Ricci-Cabello I. A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial. J Med Internet Res. 2025 Oct 9;27:e70981. doi: 10.2196/70981. |
| D004700 | Endocrine System Diseases |