VA|PREVENTION: Randomized Controlled Trial of a Person-Centred Digital Intervention to Prevent Diabetes in High-Risk Adults

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to help prevent the development of type 2 diabetes (T2D) in adults who are at risk. The study will test a digital intervention called VA\|PREVENTION, a web application designed to support and promote healthy behaviour changes known has T2D risk factors, such as physical activity, diet, and sedentary behaviuor. The main questions this study will explore are:• Is the VA\|PREVENTION web app, which includes a virtual human coach, effective in preventing type 2 diabetes?• Can the VA\|PREVENTION web app be successfully implemented in real-world settings?• Is the VA\|PREVENTION web app cost-effective?• Is it safe for participants to use?To answer these questions, the study team will compare the VA\|PREVENTION web app to an openly available guidebook that provides standard information about preventing type 2 diabetes.Participants will complete the following activities: * Participants will be randomly assigned to one of two groups: one group will use the VA\|PREVENTION app, while the other group will have access to an openly accessible guidebook on T2D prevention. * Participants will be in the study for 10 months. * Participants will be assessed at the start of the study (baseline), and again at 4 months and 10 months. * Assessments will include body measurements (such as weight, height, and waist circumference), physical activity levels, and responses to questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old;

• FINDRISC Score ≥12 (moderate, high or very high) and/or prediabetes, defined as either:

‣ HbA1c between 5.7%-6.4% within the last two years; or

⁃ Impaired Glucose Tolerance (IGT) based on an Oral Glucose Tolerance Test (OGTT) at the 120-minute mark, with values between 140 and 199 mg/dL in the past three years;

• Able to understand, speak and write Portuguese;

• Able to provide written informed consent;

• Access to a smartphone, tablet or computer with internet connection;

• Plan to reside in the recruitment/study area for the next 10 months

Locations
Other Locations
Portugal
Farmácia Alvide
RECRUITING
Alcabideche
Farmácia da Ramalha
RECRUITING
Almada
Farmácia Largo do Coreto
RECRUITING
Almada
Farmácia Nuno Álvares
RECRUITING
Almada
USF Charneca do Sol
NOT_YET_RECRUITING
Almada
USF Cova da Piedade
NOT_YET_RECRUITING
Almada
USF Inovar
NOT_YET_RECRUITING
Almada
USF São João do Pragal
RECRUITING
Almada
USF Saúde Laranjeiro
NOT_YET_RECRUITING
Almada
USF Vista Tejo
NOT_YET_RECRUITING
Almada
Farmácia Romeiro
RECRUITING
Amadora
Farmácia Santa Marta
RECRUITING
Barreiro
Farmácia Vale Fetal
RECRUITING
Caparica
USF Costa do Mar
RECRUITING
Costa Da Caparica
Farmácia Quinta da Luz
RECRUITING
Lisbon
USF Rosinha
NOT_YET_RECRUITING
Seixal
Contact Information
Primary
Mara Guerreiro, PharmD, PhD
mguerreiro@egasmoniz.edu.pt
+351 969065920
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 280
Treatments
Experimental: VA|PREVENTION web app
Participants will use the VA\|PREVENTION web application as a digital health intervention, for 10 months. They will access the app via personal devices (smartphone, tablet, or computer) and use a pedometer to self-monitor physical activity by counting steps.
Active_comparator: T2D Guidebook
Participants will have access to the Prevenção da Diabetes Tipo 2 guidebook, which provides information on diet and physical activity, along with a pedometer to self-monitor physical activity by counting steps.
Related Therapeutic Areas
Sponsors
Collaborators: Universidade Nova de Lisboa, Faculdade de Motricidade Humana de Lisboa, FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal), Nursing School of Lisbon
Leads: Egas Moniz - Cooperativa de Ensino Superior, CRL

This content was sourced from clinicaltrials.gov