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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prediabetic State

Intervention / Treatment
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* Behavioral: preDIABE-TEXT
* Other: Online Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention A<br>Participants will receive Messaging Intervention | Behavioral: preDIABE-TEXT<br>* Participants will receive text messages (three per week) in their mobile phones during six months.<br>|
| Experimental: Intervention B<br>Participants will receive messaging intervention plus online education to their primary healthcare workers | Behavioral: preDIABE-TEXT<br>* Participants will receive text messages (three per week) in their mobile phones during six months.<br>Other: Online Education<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive usual care only, and their healthcare workers will not receive online education | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months |  | Baseline and Postintervention (6 months) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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. https://www.fisterra.com/herramientas/calcumed/ | Baseline and Postintervention (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetic State, Glycemic Control, Telemedicine