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

NCT ID: NCT05110625

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-05-31

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.

Conditions

Prediabetic State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention A

Participants will receive Messaging Intervention

Group Type: EXPERIMENTAL

preDIABE-TEXT

Intervention Type: BEHAVIORAL

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

Intervention B

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

Group Type: EXPERIMENTAL

preDIABE-TEXT

Intervention Type: BEHAVIORAL

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

Online Education

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

preDIABE-TEXT

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació d'investigació Sanitària de les Illes Balears

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21987347 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26393848 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 41067715 (View on PubMed)

Other Identifiers

SYN20/04

Identifier Type: -

Identifier Source: org_study_id