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Prediabetic StatepreDIABETEXTNCT05110625

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

A study testing preDIABE-TEXT and Online Education in people with Prediabetic State, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Prediabetic State
What is being tested?
preDIABE-TEXT and Online Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
365 participants
Where
1 siteSpain
Study dates
1 Dec 2021to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Ignacio Ricci-Cabello

    Palma de Mallorca, Balearic Islands, 07002

Other trials in Spain

About this 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

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.

Read the 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.

Being tested
preDIABE-TEXT, Online Education
Keywords
Prediabetic State, Glycemic Control, Telemedicine
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • preDIABE-TEXTBehavioural

    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.

Study groups in NCT05110625
Study groupRoleWhat they receive
Intervention AExperimentalParticipants will receive Messaging Intervention
Receives: Behavioral: preDIABE-TEXT
Intervention BExperimentalParticipants will receive messaging intervention plus online education to their primary healthcare workers
Receives: Behavioral: preDIABE-TEXT; Other: Online Education
ControlNo interventionParticipants will receive usual care only, and their healthcare workers will not receive online education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months

    Measured: Baseline and Postintervention (6 months)

Secondary outcomes (26)

  1. Change from Baseline Fasting blood glucose at 6 months

    Measured: Baseline and Postintervention (6 months)

  2. Change from Baseline Triglycerides at 6 months

    Measured: Baseline and Postintervention (6 months)

  3. Change from Baseline Total Cholesterol at 6 months

    Measured: Baseline and Postintervention (6 months)

  4. Change from Baseline low density cholesterol (LDL) at 6 months

    Measured: Baseline and Postintervention (6 months)

  5. Change from Baseline high density cholesterol (HDL) at 6 months

    Measured: Baseline and Postintervention (6 months)

  6. Change from Baseline lipoprotein A at 6 months

    Measured: Baseline and Postintervention (6 months)

  7. Change from Baseline aspartate aminotransferase enzyme (AST) at 6 months

    Measured: Baseline and Postintervention (6 months)

  8. Change from Baseline alanine aminotransferase (ALT) at 6 months

    Measured: Baseline and Postintervention (6 months)

  9. Change from Baseline gamma glutamil transpeptidase (GGT) at 6 months

    Measured: Baseline and Postintervention (6 months)

  10. Change from Baseline complete hemogram at 6 months

    Measured: Baseline and Postintervention (6 months)

  11. Change from Baseline creatinine at 6 months

    Measured: Baseline and Postintervention (6 months)

  12. Change from Baseline serum albumin at 6 months

    Measured: Baseline and Postintervention (6 months)

  13. Change from Baseline insuline at 6 months

    Measured: Baseline and Postintervention (6 months)

  14. Change from Baseline urinary sediment at 6 months

    Measured: Baseline and Postintervention (6 months)

  15. Change from Baseline albumin-craetinine ratio at 6 months

    Measured: Baseline and Postintervention (6 months)

  16. Change from Baseline Body Weight at 6 months

    Measured: Baseline and Postintervention (6 months)

  17. Change from Baseline Waist Circumference at 6 months

    Measured: Baseline and Postintervention (6 months)

  18. Change from Baseline Blood Pressure at 6 months

    Measured: Baseline and Postintervention (6 months)

  19. 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)

    Measured: Baseline and Postintervention (6 months)

  20. Diagnosis of T2DM

    Measured: Postintervention (6 months)

  21. 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.

    Measured: Baseline and Postintervention (6 months)

  22. 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).

    Measured: Baseline and Postintervention (6 months)

  23. 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/

    Measured: Baseline and Postintervention (6 months)

  24. 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/

    Measured: Baseline and Postintervention (6 months)

  25. Global Adult Tobbacco Survey: GATS questionnaire.

    Tobbacco consumption. 3-items adapted from the GATS questionnaire (WHO).

    Measured: Baseline and Postintervention (6 months)

  26. 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/

    Measured: Baseline and Postintervention (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05110625
Sponsor's protocol ID
SYN20/04
Acronym
preDIABETEXT
Status last verified
Aug 2022
First submitted
5 Oct 2021
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share all collected IPD after anonymization

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.

    PubMed 21987347

  • 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.

    PubMed 26393848

  • 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.

    PubMed 41067715

Questions about this trial

What is this clinical trial studying?

A study testing preDIABE-TEXT and Online Education in people with Prediabetic State, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months (time frame: Baseline and Postintervention (6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05110625, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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