Ignacio Ricci-Cabello
Palma de Mallorca, Balearic Islands, 07002, Spain
NCT Number: NCT05110625
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Palma de Mallorca, Balearic Islands, 07002, Spain
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.
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
Exclusion criteria
Participants will receive text messages (three per week) in their mobile phones during six months.
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.
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Time frame: Baseline and Postintervention (6 months)
Cardiovascular disease risk determined using the REGICOR calculator (www.imim.cat; Ramos et al., 2003)
Time frame: Postintervention (6 months)
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.
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).
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/
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/
Time frame: Baseline and Postintervention (6 months)
Tobbacco consumption. 3-items adapted from the GATS questionnaire (WHO).
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/
Time frame: Baseline
Time frame: Baseline
follow-up rate
Time frame: Postintervention (6 months)
Fundació d'investigació Sanitària de les Illes Balears
Other Gov
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
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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