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

Fundació d'investigació Sanitària de les Illes Balears365 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

365

Conditions

Prediabetic State

Interventions

preDIABE-TEXTBEHAVIORAL

Participants will receive text messages (three per week) in their mobile phones during six months.

Online EducationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, Spain