NCT07021144Fut, nem toboroz
VA|PREVENTION: Randomized Controlled Trial of a Person-Centred Digital Intervention to Prevent Diabetes in High-Risk Adults
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 19.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 180 (tényleges)
- Első benyújtás
- 2025. máj. 27.
- Kezdés
- 2025. jún. 3.
- Elsődleges befejezés
- 2026. nov. 16.
- Fő szponzor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07021144
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 180
- 2025. jún. 3. és az elsődleges befejezés (2026. nov. 16.) között
- 16 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Having undergone bariatric surgery within the past 3 years or planning surgery within the next 10 months;
- Participating in a concurrent weight management program and/or relevant interventional research protocol;
Más betegség
- Established Type 1 and 2 Diabetes Mellitus diagnosis;
- 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;
- Any mental health condition, including, but not limited to, eating disorders or alcohol/substance abuse, that would impact fully participating on the study;
- Existing thyroid disorder;
- Active cancer or less than 6 months from treatment;
Egyéb
- Pregnancy - Self-reported as currently pregnant, planning to become pregnant, or not practicing contraception, in the following 10 months (if applicable);
- Following a prescribed medical diet;
- Contraindication to physical activity or weight loss;
- 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.
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (16)
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