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

Prediabetic State Clinical Trial

— preDIABETEXT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05110625
• Other study ID #: SYN20/04
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: August 2022
• Source: Fundació d'investigació Sanitària de les Illes Balears
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 420
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
Spain	Ignacio Ricci-Cabello	Palma De Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. Erratum in: JAMA. 2016 Mar 8;315(10):1057. — View Citation

Soriguer F, Goday A, Bosch-Comas A, Bordiú E, Calle-Pascual A, Carmena R, Casamitjana R, Castaño L, Castell C, Catalá M, Delgado E, Franch J, Gaztambide S, Girbés J, Gomis R, Gutiérrez G, López-Alba A, Martínez-Larrad MT, Menéndez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martínez G, Serrano-Rios M, Valdés S, Vázquez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of eligible patients		Baseline
Other	Recruitment rate	follow-up rate	Baseline
Other	Follow-up rate		Postintervention (6 months)
Primary	Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline Fasting blood glucose at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline Triglycerides at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline Total Cholesterol at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline low density cholesterol (LDL) at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline high density cholesterol (HDL) at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline lipoprotein A at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline aspartate aminotransferase enzyme (AST) at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline alanine aminotransferase (ALT) at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline gamma glutamil transpeptidase (GGT) at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline complete hemogram at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline creatinine at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline serum albumin at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline insuline at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline urinary sediment at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline albumin-craetinine ratio at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline Body Weight at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline Waist Circumference at 6 months		Baseline and Postintervention (6 months)
Secondary	Change from Baseline Blood Pressure at 6 months		Baseline and Postintervention (6 months)
Secondary	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)	Baseline and Postintervention (6 months)
Secondary	Diagnosis of T2DM		Postintervention (6 months)
Secondary	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.	Baseline and Postintervention (6 months)
Secondary	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).	Baseline and Postintervention (6 months)
Secondary	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/	Baseline and Postintervention (6 months)
Secondary	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/	Baseline and Postintervention (6 months)
Secondary	Global Adult Tobbacco Survey: GATS questionnaire.	Tobbacco consumption. 3-items adapted from the GATS questionnaire (WHO).	Baseline and Postintervention (6 months)
Secondary	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/	Baseline and Postintervention (6 months)