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

NCT05110625 | Completed

• 1 other identifier: SYN20/04
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State

Keywords

Prediabetic State; Glycemic Control; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months

  Baseline and Postintervention (6 months)

Secondary Outcomes (26)

• 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)

Other Outcomes (3)

• Number of eligible patients

  Baseline

• Recruitment rate

  Baseline

• Follow-up rate

  Postintervention (6 months)

Study Arms (3)

Intervention A

EXPERIMENTAL

Participants will receive Messaging Intervention

Behavioral: preDIABE-TEXT

Intervention B

EXPERIMENTAL

Participants will receive messaging intervention plus online education to their primary healthcare workers

Behavioral: preDIABE-TEXT; Other: Online Education

Control

NO INTERVENTION

Participants will receive usual care only, and their healthcare workers will not receive online education

Interventions

preDIABE-TEXT BEHAVIORAL

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

Intervention A; Intervention B

Online Education OTHER

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.

Intervention B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, 07002, Spain

Location

Related Publications (3)

• 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.

  PMID: 21987347 BACKGROUND

• 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.

  PMID: 26393848 BACKGROUND

• Mira-Martinez S, Malih N, Angullo-Martinez E, Zamanillo-Campos R, Yanez AM, Bennasar-Veny M, Gomez-Juanes R, Konieczna J, Jimenez R, Serrano-Ripoll MJ, Fiol-deRoque MA, Leiva A, Galmes-Panades AM, Miralles-Xamena J, Vidal-Thomas MC, Gomez-Cobo C, Gervilla E, Ona-Gil JI, Ricci-Cabello I. A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial. J Med Internet Res. 2025 Oct 9;27:e70981. doi: 10.2196/70981.

  PMID: 41067715 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 8, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 23, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from January 2023 onwards
• Access Criteria: Upon a reasonable request, we will grant access to public organizations. The PI of the project will review the requests.

Locations

ES (1)