Active — Not RecruitingNot Applicable

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

Portugal180 participantsStarted 2025-06-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Established Type 1 and 2 Diabetes Mellitus diagnosis; * Pregnancy - Self-reported as currently pregnant, planning to become pregnant, or not practicing contraception, in the following 10 months (if applicable); * Conditions precluding technology use (e.g. cognitive decline, dependent upon a carer for daily activities); * Use of anti-obesity or diabetes medication, such as Metformin, Glucagon-like peptide-1 analogue (GLP-1), or other medications known to significantly impact weight (either gain or loss), currently or within the preceding 3 months; * Following a prescribed medical diet; * Having undergone bariatric surgery within the past 3 years or planning surgery within the next 10 months; * Any mental health condition, including, but not limited to, eating disorders or alcohol/substance abuse, that would impact fully participating on the study; * Participating in …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in waist circumference (WC)

Timeframe: Baseline (T0), 4 months (T1), 10 months (T2)

Trial details

NCT IDNCT07021144

SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-16

View on ClinicalTrials.gov More Pre-diabetes trials