Clinical trial NCT05110625: mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: Prediabetic State
Glycemic Control
Telemedicine
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
First posted: 2021-11-08
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months
timeFrame: Baseline and Postintervention (6 months)
Secondary outcomes:
measure: Change from Baseline Fasting blood glucose at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline Triglycerides at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline Total Cholesterol at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline low density cholesterol (LDL) at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline high density cholesterol (HDL) at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline lipoprotein A at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline aspartate aminotransferase enzyme (AST) at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline alanine aminotransferase (ALT) at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline gamma glutamil transpeptidase (GGT) at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline complete hemogram at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline creatinine at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline serum albumin at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline insuline at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline urinary sediment at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline albumin-craetinine ratio at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline Body Weight at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline Waist Circumference at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline Blood Pressure at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Change from Baseline of Cardiovascular disease risk at 6 months
timeFrame: Baseline and Postintervention (6 months)
measure: Diagnosis of T2DM
timeFrame: Postintervention (6 months)
measure: Brief motivation questionnaire (ad hoc)
timeFrame: Baseline and Postintervention (6 months)
measure: 14-point Mediterranean diet adherence screener (MEDAS-14)
timeFrame: Baseline and Postintervention (6 months)
measure: REGICOR Short form Physical Activity Questionnaire
timeFrame: Baseline and Postintervention (6 months)
measure: Spanish version of the physical activity questionnaire used in the Physical activity questionnaire from the Nurses' Health Study
timeFrame: Baseline and Postintervention (6 months)
measure: Global Adult Tobbacco Survey: GATS questionnaire.
timeFrame: Baseline and Postintervention (6 months)
measure: Quantification of alcohol consumption - FISTERRA
timeFrame: Baseline and Postintervention (6 months)
Other outcomes:
measure: Number of eligible patients
timeFrame: Baseline
measure: Recruitment rate
timeFrame: Baseline
measure: Follow-up rate
timeFrame: Postintervention (6 months)
Locations:
city: Palma De Mallorca
country: Spain
facility: Ignacio Ricci-Cabello
state: Balearic Islands
Study officials:
References:
citation: 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.
citation: 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.