mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II Study)
- Conditions
- Prediabetic State
- Interventions
- Behavioral: preDIABE-TEXTOther: Online Education
- Registration Number
- NCT05110625
- Lead Sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention B preDIABE-TEXT Participants will receive messaging intervention plus online education to their primary healthcare workers Intervention B Online Education Participants will receive messaging intervention plus online education to their primary healthcare workers Intervention A preDIABE-TEXT Participants will receive Messaging Intervention
- Primary Outcome Measures
Name Time Method Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months Baseline and Postintervention (6 months)
- Secondary Outcome Measures
Name Time Method Change from Baseline high density cholesterol (HDL) 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 Fasting blood glucose 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 Waist Circumference at 6 months Baseline and Postintervention (6 months) Change from Baseline of Cardiovascular disease risk at 6 months Baseline and Postintervention (6 months) Cardiovascular disease risk determined using the REGICOR calculator (www.imim.cat; Ramos et al., 2003)
Change from Baseline low density cholesterol (LDL) at 6 months Baseline and Postintervention (6 months) Change from Baseline urinary sediment at 6 months Baseline and Postintervention (6 months) Change from Baseline Blood Pressure at 6 months Baseline and Postintervention (6 months) Quantification of alcohol consumption - FISTERRA Baseline and Postintervention (6 months) Calcultaion of alcohol consumption in Spanish Standard Drink units (10g per unit) per week.
https://www.fisterra.com/herramientas/calcumed/Change from Baseline complete hemogram 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) Diagnosis of T2DM Postintervention (6 months) REGICOR Short form Physical Activity Questionnaire Baseline and Postintervention (6 months) 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/
Change from Baseline gamma glutamil transpeptidase (GGT) 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) Brief motivation questionnaire (ad hoc) Baseline and Postintervention (6 months) 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.
Change from Baseline insuline at 6 months Baseline and Postintervention (6 months) 14-point Mediterranean diet adherence screener (MEDAS-14) Baseline and Postintervention (6 months) 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).
Spanish version of the physical activity questionnaire used in the Physical activity questionnaire from the Nurses' Health Study Baseline and Postintervention (6 months) 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/Global Adult Tobbacco Survey: GATS questionnaire. Baseline and Postintervention (6 months) Tobbacco consumption. 3-items adapted from the GATS questionnaire (WHO).
Trial Locations
- Locations (1)
Ignacio Ricci-Cabello
🇪🇸Palma De Mallorca, Balearic Islands, Spain