Clinical Trials Logo
  1. Home
  2. Prediabetic State
  3. NCT05110625

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

Prediabetic State Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05110625
Study type Interventional
Source Fundació d'investigació Sanitària de les Illes Balears
Contact
Status Enrolling by invitation
Phase N/A
Start date December 1, 2021
Completion date January 31, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT05424107 - A Mediterranean Intervention on Prediabetic Children N/A
Recruiting NCT02681887 - Effect of Melatonin on Cardiometabolic Risk- FULL Phase 3
Completed NCT04088461 - Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine Phase 4
Recruiting NCT02561377 - Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics) N/A
Completed NCT02551640 - Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients N/A
Completed NCT02678390 - Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes N/A
Completed NCT02459691 - Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos) N/A
Completed NCT01671293 - Multicomponent Telecare Model for Supporting Prediabetes Patients N/A
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT00960973 - The Effect of Vitamin K Supplementation on Glucose Metabolism Phase 4
Completed NCT00455325 - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) Phase 2
Recruiting NCT05123963 - Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors N/A
Recruiting NCT05340868 - Genetics of the Acute Response to Oral Semaglutide N/A
Recruiting NCT04984421 - IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE) N/A
Recruiting NCT04131582 - Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes Phase 3
Recruiting NCT04134650 - Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes Phase 3
Recruiting NCT05347030 - Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population N/A
Completed NCT04074148 - Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal N/A
Recruiting NCT05050266 - Enhancing Mental and Physical Health of Women Veterans N/A
Completed NCT02684565 - Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects N/A