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

NCT ID: NCT07021144

Last Updated: 2026-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2026-11-25

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.

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.

Conditions

Pre-diabetes; Pre-diabetic State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VA|PREVENTION web app

Participants 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.

Group Type: EXPERIMENTAL

VA|PREVENTION web application (digital intervention)

Intervention Type: BEHAVIORAL

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 Guidebook

Participants 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.

Group Type: ACTIVE_COMPARATOR

Type 2 Diabetes Guidebook

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Nova de Lisboa

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Nursing School of Lisbon

OTHER

Sponsor Role: collaborator

Faculdade de Motricidade Humana de Lisboa

UNKNOWN

Sponsor Role: collaborator

Egas Moniz - Cooperativa de Ensino Superior, CRL

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USF Cova da Piedade

Almada, Almada, Portugal

USF Rosinha

Seixal, Amora, Portugal

USF Charneca do Sol

Almada, Charneca Da Caparica, Portugal

USF Inovar

Almada, Corroios, Portugal

USF Saúde Laranjeiro

Almada, Fernão Ferro, Portugal

USF Vista Tejo

Almada, Monte Da Caparica, 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

Countries

Portugal

References

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.

Reference Type: BACKGROUND

PMID: 7975354 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25908607 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21479777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34265011 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18091006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28303543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32525912 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12610029 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32020062 (View on PubMed)

Other Identifiers

VA|PREVENTION_01

Identifier Type: -

Identifier Source: org_study_id