AzTrials
AzTrials

Pre-diabetesVA|PREVENTIONNCT07021144

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

A study testing VA|PREVENTION web application (digital intervention) and Type 2 Diabetes Guidebook in people with Pre-diabetes and Pre-diabetic State, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 16 sites in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pre-diabetes, Pre-diabetic State
What is being tested?
VA|PREVENTION web application (digital intervention) and Type 2 Diabetes Guidebook
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
16 sitesPortugal
Study dates
3 Jun 2025to 25 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 14Show fewer
  • 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 a concurrent weight management program and/or relevant interventional research protocol;
  • Contraindication to physical activity or weight loss;
  • Existing thyroid disorder;
  • Active cancer or less than 6 months from treatment;
  • Unable to provide informed consent or absence of a legal representative that can provided it on behalf of the patient;
  • Institutionalised adults;
  • Foreseeable difficulty in attending study visits.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Portugal16 sites

  • Farmácia Alvide

    Alcabideche

  • USF Cova da Piedade

    Almada, Almada, 2809-010

  • USF Charneca do Sol

    Almada, Charneca Da Caparica, 2820-225

  • USF Inovar

    Almada, Corroios, 2855-697

  • USF Saúde Laranjeiro

    Almada, Fernão Ferro, 2810-186

  • USF Vista Tejo

    Almada, Monte Da Caparica, 2825-023

  • Farmácia da Ramalha

    Almada

  • Farmácia Largo do Coreto

    Almada

  • Farmácia Nuno Álvares

    Almada

  • USF São João do Pragal

    Almada

  • Farmácia Romeiro

    Amadora

  • Farmácia Santa Marta

    Barreiro

  • Farmácia Vale Fetal

    Caparica

  • USF Costa do Mar

    Costa da Caparica

  • Farmácia Quinta da Luz

    Lisbon

  • USF Rosinha

    Seixal, Amora, 2845-422

Other trials in Portugal

About this study

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.
Read the detailed description

T2D risk adults will be invited by nurses and community pharmacists, leveraging their trusted roles within the healthcare system. Recruitment activities will prioritize fair treatment and respect for informed consent. Only participants fully capable of understanding the informed consent terms will be included in the study. Potential participants will receive detailed information about the study's purpose, procedures, potential risks, and benefits. After providing time for questions and discussion, written informed consent will be obtained. Following consent, participants will undergo screening to confirm eligibility according to predefined inclusion and exclusion criteria. Those meeting all eligibility criteria will proceed to the baseline visit (T0), during which initial assessments will be conducted. After the baseline assessment, participants will be randomized into one of the study groups. Following randomization, the assigned intervention will be initiated, with subsequent visits scheduled at 4 months (T1) and 10 months (T2) for data collection.Upon obtaining informed consent, participants will undergo screening to verify eligibility according to predefined inclusion and exclusion criteria. Those who meet all criteria will proceed to the baseline visit (T0), where initial assessments will be conducted. Following this, participants will be randomly assigned to one of the study groups. The assigned intervention will then be initiated, with subsequent visits scheduled at 4 months (T1) and 10 months (T2) for data collection. At these timepoints, waist circumference, the primary endpoint, as well as data on anthropometric measurements (heigh and weight), diabetes risk (FINDRISC score), dietary adherence (through MEDAS questionnaire), physical activity (through accelerometry measurements), and health resources utilization will be collected.

Being tested
VA|PREVENTION web application (digital intervention), Type 2 Diabetes Guidebook
Keywords
Diabetes Prevention via a Virtual Human Coach, Digital behaviour change intervention, Hybrid Effectiveness-Implementation Randomised Controlled Trial, Cost-Effectiveness, Type 2 Diabetes Prevention
Medical subject headings
Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VA|PREVENTION web application (digital intervention)Behavioural

    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.

  • Type 2 Diabetes GuidebookBehavioural

    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.

Study groups in NCT07021144
Study groupRoleWhat they receive
VA|PREVENTION web appExperimentalParticipants 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.
Receives: Behavioral: VA|PREVENTION web application (digital intervention)
T2D GuidebookActive comparatorParticipants 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.
Receives: Behavioral: Type 2 Diabetes Guidebook

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in waist circumference (WC)

    The measurement of WC will be conducted using a standardized procedure (NIH, 1994; Pimenta et al., 2015; Ross et al., 2020) with an inelastic metallic anthropometric tape. The measurement of WC will be repeated 2 times, and if the second differed more than 1 cm from the first measurement, a third measurement will be carried out. We always considered the result obtained in the second measurement unless a third measurement is carried out. If a third measurement is taken, we will consider the mode or, if mode was absent, the median value of all 3 measurements.

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

Secondary outcomes (8)

  1. Change in FINDRISC Score categories

    FINDRISC risk score, is a validated tool for identifying individuals at high risk of developing T2DM. It incorporates various risk factors, including age, BMI, WC, and lifestyle habits (Lindström \& Tuomilehto, 2003). Evaluating changes in FINDRISC categories allows for the assessment of the intervention's impact on overall diabetes risk, offering a comprehensive view of risk factor modification (WHO, 2020). FINDRISC risk score categories allow a maximum score of 26 points and classifies individuals into risk levels: low (< 7 points); mildly moderate (between 7 and 11 points); moderate (12-14 points); high (15-20 points) and very high (more than 20 points) (Dantas, 2017; Lindström \& Tuomilehto, 2003).

    Measured: Baseline (T0), 4 months (T1), 10 months (T2).

  2. Change in Body Weight and Body Mass Index

    Body weight will be measured using a digital scale that is pre-calibrated and placed on a flat, firm surface, with participants barefoot and wearing only light clothing without accessories. Body height will be measured as the highest point of the cranium (vertex) and the horizontal surface where the individual's feet are standing, in an upright position, using a stadiometer, following a standard protocol (Gordon, Chumlea and Roche, 1988). Body mass index will be calculated using body weight (in kilograms) divided by body height squared (in meters). The measurement of body weight and height will be repeated 2 times, and if the second differed more then 0.5 kg (for weight) or 1.0 cm (for height) from the first measurement, a third measurement will be carried out. We always considered the result obtained in the second measurement unless a third measurement is carried out. When a third measurement is taken, we will consider the mode or, if mode was absent, the median value of all 3.

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

  3. Change in Physical Activity and Sedentary Behaviour

    Change in dietary behaviours will be assessed through MEDAS questionnaire. This questionnaire includes 14 items that evaluate the intake of key components of the Mediterranean diet. This is a validated tool widely used in research to assess adherence to the Mediterranean diet, which is strongly associated with reduced risk of type 2 diabetes (Martínez-González et al., 2012).

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

  4. Change in Dietary Behaviours

    Change in dietary behaviours will be assessed through MEDAS questionnaire. This questionnaire includes 14 items that evaluate the intake of key components of the Mediterranean diet. This is a validated tool widely used in research to assess adherence to the Mediterranean diet, which is strongly associated with reduced risk of type 2 diabetes (Martínez-González et al., 2012).

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

  5. Quality of Life (QoL)

    Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. This instrument evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L is widely accepted in clinical research and is considered a reliable measure of health outcomes over time (Herdman et al., 2011).

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

  6. Digital intervention Usage and Engagement (Adoption)

    Adoption will be assessed via rates and retention, based on data collected by user and second users' interactions with the VA|PREVENTION web app. This includes:

    1. Number of complete interactions with Ema for physical activity and dietary behaviours over the intervention period;
    2. Number of complete topics answered in the educational menus;
    3. Number of visits to the dashboard: (i) educative menus usage data ; (ii) self-monitoring and goal progress features; and (iii) feature showing the number of interactions with Ema;
    4. Length of use of: i) interactions with Ema; ii) Educative Menus; and iii) Dashboard for physical activity and dietary behaviours;
    5. Frequency of use of: i) interactions with Ema; ii) Educative Menus; and iii) Dashboard for physical activity and dietary behaviours
    6. Number of secondary users that access the dashboard
    7. Number of visits of secondary users to the dashboard;

    Measured: Over the course of each participant's study period (expected to be for 10 months)

  7. Acceptability, Appropriateness, and Feasibility of Intervention

    The acceptability, appropriateness, and feasibility of the VA|PREVENTION web app will be assessed through the evaluation of:

    1. Acceptability, Appropriateness and Feasibility questionnaire responded by participants/users, secondary users and managers; Each section of the questionnaire has 4 items, responded on a 5-point likert scale, ranging from completely disagree to completely agree.
    2. Qualitative data from interviews with primary and secondary users.
    3. Qualitative date from interviews with managers of Primary Care Units and Community pharmacies; These will be telephone interviews, and thematic saturation will be used to determine the size of the samples with a minimum of 20 interviews planned for primary users, and a minimum of 10 participants for each of the remaining samples is envisaged.

    Measured: Acceptability, Appropriateness and Feasibility questionnaire responded by users, will be assessed at the end of the study visit (T3, 10 month). Interviews will be conducted after study visits completed.

  8. Cost-effectiveness

    Cost-effectiveness of the web app will be assessed through Incremental Cost-Effectiveness Ratio (ICER). ICER represent the ratio of the difference in costs and the difference in health outcomes. ICERs will be calculated for the comparison of the web app intervention with control group.

    The primary ICER will be computed as cost per QALY derived using utility values calculated from the EQ-5D-5L instrument. In addition, ICERs can also be reported for the relation with other secondary outcomes, such as cost per cm reduction in waist circumference, or cost per point reduction in FINDRISC risk score.

    The cost-effectiveness analysis will adopt a healthcare payer perspective.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start3 Jun 2025
  3. Primary completion16 Nov 2026 (estimated)
  4. Study completion25 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021144
Sponsor's protocol ID
VA|PREVENTION_01
Acronym
VA|PREVENTION
Status last verified
Feb 2026
First submitted
27 May 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be made available in an aggregated form and will not be directly linked to the participants, making it impossible to associate the data with their identity. This data will be accessible on the national open-access repository promoted by the project's funder Fundação para a Ciência e Tecnologia (FCT), known as the Polen repository. Access will public for studies previously submitted and approved by an ethics committee and are deemed relevant, allowing other researchers to use it to advance scientific research and the development of new solutions in the healthcare field.

Publications

  • Plan and operation of the Third National Health and Nutrition Examination Survey, 1988-94. Series 1: programs and collection procedures. Vital Health Stat 1. 1994 Jul;(32):1-407.

    PubMed 7975354

  • Pimenta NM, Santa-Clara H, Melo X, Cortez-Pinto H, Silva-Nunes J, Sardinha LB. Finding the Best Waist Circumference Measurement Protocol in Patients With Nonalcoholic Fatty Liver Disease. Nutr Clin Pract. 2015 Aug;30(4):537-45. doi: 10.1177/0884533615583092. Epub 2015 Apr 23.

    PubMed 25908607

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • Altenburg TM, Wang X, van Ekris E, Andersen LB, Moller NC, Wedderkopp N, Chinapaw MJM. The consequences of using different epoch lengths on the classification of accelerometer based sedentary behaviour and physical activity. PLoS One. 2021 Jul 15;16(7):e0254721. doi: 10.1371/journal.pone.0254721. eCollection 2021.

    PubMed 34265011

  • Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008 Jan;40(1):181-8. doi: 10.1249/mss.0b013e31815a51b3.

    PubMed 18091006

  • Migueles JH, Cadenas-Sanchez C, Ekelund U, Delisle Nystrom C, Mora-Gonzalez J, Lof M, Labayen I, Ruiz JR, Ortega FB. Accelerometer Data Collection and Processing Criteria to Assess Physical Activity and Other Outcomes: A Systematic Review and Practical Considerations. Sports Med. 2017 Sep;47(9):1821-1845. doi: 10.1007/s40279-017-0716-0.

    PubMed 28303543

  • Mikkelsen MK, Berg-Beckhoff G, Frederiksen P, Horgan G, O'Driscoll R, Palmeira AL, Scott SE, Stubbs J, Heitmann BL, Larsen SC. Estimating physical activity and sedentary behaviour in a free-living environment: A comparative study between Fitbit Charge 2 and Actigraph GT3X. PLoS One. 2020 Jun 11;15(6):e0234426. doi: 10.1371/journal.pone.0234426. eCollection 2020.

    PubMed 32525912

  • Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. doi: 10.2337/diacare.26.3.725.

    PubMed 12610029

  • Ross R, Neeland IJ, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin BA, Zambon A, Barter P, Fruchart JC, Eckel RH, Matsuzawa Y, Despres JP. Waist circumference as a vital sign in clinical practice: a Consensus Statement from the IAS and ICCR Working Group on Visceral Obesity. Nat Rev Endocrinol. 2020 Mar;16(3):177-189. doi: 10.1038/s41574-019-0310-7. Epub 2020 Feb 4.

    PubMed 32020062

Questions about this trial

What is this clinical trial studying?

A study testing VA|PREVENTION web application (digital intervention) and Type 2 Diabetes Guidebook in people with Pre-diabetes and Pre-diabetic State, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 16 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in waist circumference (WC) (time frame: Baseline (T0), 4 months (T1), 10 months (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021144, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in