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

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetic State
• Intervention / Treatment: Behavioral: preDIABE-TEXT; Other: Online Education

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.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Balearic Islands
    • Palma De Mallorca, Balearic Islands, Spain, 07002
      • Ignacio Ricci-Cabello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eligible patients		Baseline
Recruitment rate	follow-up rate	Baseline
Follow-up rate		Postintervention (6 months)

Collaborators and Investigators

• Sponsor: Fundació d'investigació Sanitària de les Illes Balears

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: JAMA. 2016 Mar 8;315(10):1057. doi: 10.1001/jama.2016.0809.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Prediabetic State; Glycemic Control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: SYN20/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share all collected IPD after anonymization
• IPD Sharing Time Frame: Data will be available from January 2023 onwards
• IPD Sharing Access Criteria: Upon a reasonable request, we will grant access to public organizations. The PI of the project will review the requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No