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Trial record 2 of 6 for:    ricci-cabello

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05110625
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2021
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears

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.

Condition or disease Intervention/treatment Phase
Prediabetic State Behavioral: preDIABE-TEXT Other: Online Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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



Primary Outcome Measures :
  1. Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months [ Time Frame: Baseline and Postintervention (6 months) ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05110625


Locations
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Spain
Ignacio Ricci-Cabello
Palma De Mallorca, Balearic Islands, Spain, 07002
Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Publications:
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Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier: NCT05110625    
Other Study ID Numbers: SYN20/04
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share all collected IPD after anonymization
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació d'investigació Sanitària de les Illes Balears:
Prediabetic State
Glycemic Control
Telemedicine
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases