VA|PREVENTION: Randomized Controlled Trial of a Person-Centred Digital Intervention to Prevent Diabetes in High-Risk Adults
VA|PREVENTION
1 other identifier
interventional
180
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2025
CompletedStudy Start
First participant enrolled
June 3, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 25, 2026
February 19, 2026
February 1, 2026
1.5 years
May 27, 2025
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline (T0), 4 months (T1), 10 months (T2)
Secondary Outcomes (8)
Change in FINDRISC Score categories
Baseline (T0), 4 months (T1), 10 months (T2).
Change in Body Weight and Body Mass Index
Baseline (T0), 4 months (T1), 10 months (T2)
Change in Physical Activity and Sedentary Behaviour
Baseline (T0), 4 months (T1), 10 months (T2)
Change in Dietary Behaviours
Baseline (T0), 4 months (T1), 10 months (T2)
Quality of Life (QoL)
Baseline (T0), 4 months (T1), 10 months (T2)
- +3 more secondary outcomes
Other Outcomes (1)
Rate of Adverse Events and Software Issues
Continuously, with formal assessments at 4 months (T1), 10 months (T2)
Study Arms (2)
VA|PREVENTION web app
EXPERIMENTALParticipants 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.
T2D Guidebook
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
USF Cova da Piedade
Almada, Almada, 2809-010, Portugal
USF Rosinha
Seixal, Amora, 2845-422, Portugal
USF Charneca do Sol
Almada, Charneca Da Caparica, 2820-225, Portugal
USF Inovar
Almada, Corroios, 2855-697, Portugal
USF Saúde Laranjeiro
Almada, Fernão Ferro, 2810-186, Portugal
USF Vista Tejo
Almada, Monte Da Caparica, 2825-023, Portugal
Farmácia Alvide
Alcabideche, Portugal
Farmácia da Ramalha
Almada, Portugal
Farmácia Largo do Coreto
Almada, Portugal
Farmácia Nuno Álvares
Almada, Portugal
USF São João do Pragal
Almada, Portugal
Farmácia Romeiro
Amadora, Portugal
Farmácia Santa Marta
Barreiro, Portugal
Farmácia Vale Fetal
Caparica, Portugal
USF Costa do Mar
Costa da Caparica, Portugal
Farmácia Quinta da Luz
Lisbon, Portugal
Related Publications (9)
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.
PMID: 7975354BACKGROUNDPimenta 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.
PMID: 25908607BACKGROUNDHerdman 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.
PMID: 21479777BACKGROUNDAltenburg 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.
PMID: 34265011BACKGROUNDTroiano 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.
PMID: 18091006BACKGROUNDMigueles 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.
PMID: 28303543BACKGROUNDMikkelsen 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.
PMID: 32525912BACKGROUNDLindstrom 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.
PMID: 12610029BACKGROUNDRoss 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.
PMID: 32020062BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2025
First Posted
June 13, 2025
Study Start
June 3, 2025
Primary Completion (Estimated)
November 16, 2026
Study Completion (Estimated)
November 25, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data generated by the study will be made publicly accessible within 18 to 24 months following the completion of the project studies.
- Access Criteria
- Access will be granted through the Polen repository, which is provided by Portugal's national science funding agency, Fundação para a Ciência e a Tecnologia, I.P. (FCT).
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.