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Completed

NCT Number: NCT05110625

mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, 07002, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preDIABE-TEXT

Behavioral

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

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.

Primary outcomes

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

    Time frame: Baseline and Postintervention (6 months)

Secondary outcomes

  1. Change from Baseline Fasting blood glucose at 6 months

    Time frame: Baseline and Postintervention (6 months)

  2. Change from Baseline Triglycerides at 6 months

    Time frame: Baseline and Postintervention (6 months)

  3. Change from Baseline Total Cholesterol at 6 months

    Time frame: Baseline and Postintervention (6 months)

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

    Time frame: Baseline and Postintervention (6 months)

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

    Time frame: Baseline and Postintervention (6 months)

  6. Change from Baseline lipoprotein A at 6 months

    Time frame: Baseline and Postintervention (6 months)

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

    Time frame: Baseline and Postintervention (6 months)

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

    Time frame: Baseline and Postintervention (6 months)

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

    Time frame: Baseline and Postintervention (6 months)

  10. Change from Baseline complete hemogram at 6 months

    Time frame: Baseline and Postintervention (6 months)

  11. Change from Baseline creatinine at 6 months

    Time frame: Baseline and Postintervention (6 months)

  12. Change from Baseline serum albumin at 6 months

    Time frame: Baseline and Postintervention (6 months)

  13. Change from Baseline insuline at 6 months

    Time frame: Baseline and Postintervention (6 months)

  14. Change from Baseline urinary sediment at 6 months

    Time frame: Baseline and Postintervention (6 months)

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

    Time frame: Baseline and Postintervention (6 months)

  16. Change from Baseline Body Weight at 6 months

    Time frame: Baseline and Postintervention (6 months)

  17. Change from Baseline Waist Circumference at 6 months

    Time frame: Baseline and Postintervention (6 months)

  18. Change from Baseline Blood Pressure at 6 months

    Time frame: Baseline and Postintervention (6 months)

  19. Change from Baseline of Cardiovascular disease risk at 6 months

    Time frame: Baseline and Postintervention (6 months)

    Cardiovascular disease risk determined using the REGICOR calculator (www.imim.cat; Ramos et al., 2003)

  20. Diagnosis of T2DM

    Time frame: Postintervention (6 months)

  21. Brief motivation questionnaire (ad hoc)

    Time frame: Baseline and Postintervention (6 months)

    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.

  22. 14-point Mediterranean diet adherence screener (MEDAS-14)

    Time frame: Baseline and Postintervention (6 months)

    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).

  23. REGICOR Short form Physical Activity Questionnaire

    Time frame: Baseline and Postintervention (6 months)

    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/

  24. Spanish version of the physical activity questionnaire used in the Physical activity questionnaire from the Nurses' Health Study

    Time frame: Baseline and Postintervention (6 months)

    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/

  25. Global Adult Tobbacco Survey: GATS questionnaire.

    Time frame: Baseline and Postintervention (6 months)

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

  26. Quantification of alcohol consumption - FISTERRA

    Time frame: Baseline and Postintervention (6 months)

    Calcultaion of alcohol consumption in Spanish Standard Drink units (10g per unit) per week.

    https://www.fisterra.com/herramientas/calcumed/

Other outcomes

  1. Number of eligible patients

    Time frame: Baseline

  2. Recruitment rate

    Time frame: Baseline

    follow-up rate

  3. Follow-up rate

    Time frame: Postintervention (6 months)

Sponsors and collaborators

Lead sponsor

Fundació d'investigació Sanitària de les Illes Balears

Other Gov

Registry information

Official study 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

Acronym: preDIABETEXT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2021
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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