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

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.

Conditions

• Pre-diabetes
• Pre-diabetic State

Interventions

BEHAVIORAL

VA|PREVENTION web application (digital intervention)

VA\|PREVENTION web app, a digital intervention incorporating behaviour change techniques delivered by a Virtual Human Coach (VHC), educational content and progress tracking via a dashboard.

BEHAVIORAL

Type 2 Diabetes Guidebook

T2D prevention guidebook, an educational material that include standard guidelines on healthy eating and the importance of regular physical activity and reduction of sedentary behaviour.

Sponsors & Collaborators

• Universidade Nova de Lisboa

  collaborator OTHER

• FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal)

  collaborator UNKNOWN

• Nursing School of Lisbon

  collaborator OTHER

• Faculdade de Motricidade Humana de Lisboa

  collaborator UNKNOWN

• Egas Moniz - Cooperativa de Ensino Superior, CRL

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-03

Primary Completion

2026-11-16

Completion

2026-11-25

Countries

• Portugal

Study Locations