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

Last updated: June 6, 2025
Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes (Pediatric)

Diabetes And Hypertension

Treatment

VA|PREVENTION web application (digital intervention)

Type 2 Diabetes Guidebook

Clinical Study ID

NCT07021144
VA|PREVENTION_01
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to help prevent the development of type 2 diabetes (T2D) in adults who are at high 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old;

  • FINDRISC Score ≥15 (high or very high);

  • 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

Exclusion Criteria:

  • Established Type 1 and 2 Diabetes Mellitus diagnosis;

  • Pregnancy - Self-reported as currently pregnant, planning to become pregnant, or notpracticing contraception, in the following 10 months (if applicable);

  • Conditions precluding technology use (e.g. cognitive decline, dependent upon a carerfor daily activities);

  • Use of anti-obesity or diabetes medication, such as Metformin, Glucagon-likepeptide-1 analogue (GLP-1), or other medications known to significantly impactweight (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 surgerywithin the next 10 months;

  • Any mental health condition, including, but not limited to, eating disorders oralcohol/substance abuse, that would impact fully participating on the study;

  • Participating in a concurrent weight management program and/or relevantinterventional 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 canprovided it on behalf of the patient;

  • Institutionalised adults;

  • Foreseeable difficulty in attending study visits.

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: VA|PREVENTION web application (digital intervention)
Phase:
Study Start date:
May 26, 2025
Estimated Completion Date:
August 31, 2026

Study Description

T2D high 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.

Connect with a study center

  • Farmácia Alvide

    Alcabideche,
    Portugal

    Active - Recruiting

  • Farmácia Largo do Coreto

    Almada,
    Portugal

    Active - Recruiting

  • Farmácia Nuno Álvares

    Almada,
    Portugal

    Active - Recruiting

  • Farmácia da Ramalha

    Almada,
    Portugal

    Active - Recruiting

  • USF São João do Pragal

    Almada,
    Portugal

    Active - Recruiting

  • Farmácia Romeiro

    Amadora,
    Portugal

    Active - Recruiting

  • Farmácia Santa Marta

    Barreiro,
    Portugal

    Active - Recruiting

  • Farmácia Vale Fetal

    Caparica,
    Portugal

    Active - Recruiting

  • USF Costa do Mar

    Costa da Caparica,
    Portugal

    Active - Recruiting

  • Farmácia Quinta da Luz

    Lisboa,
    Portugal

    Active - Recruiting

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