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| Name | Class |
|---|---|
| Universidade Nova de Lisboa | OTHER |
| FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal) | UNKNOWN |
| Nursing School of Lisbon | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VA|PREVENTION web app | Experimental | 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. |
|
| T2D Guidebook | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VA|PREVENTION web application (digital intervention) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events and Software Issues | The assessment of adverse events and software issues will focus on the identification and reporting of both serious and non-serious adverse events, as well as any deficiencies related to the investigational digital intervention. Continuous monitoring of adverse events is crucial to safeguard participant safety and maintain the integrity of the study's outcomes. |
Inclusion Criteria:
Age ≥ 18 years old;
FINDRISC Score ≥12 (moderate, high or very high) and/or prediabetes, defined as either:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Cova da Piedade | Almada | Almada | 2809-010 | Portugal | ||
| USF Rosinha |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7975354 | Background | 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. | |
| 25908607 | Background | 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. |
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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.
Data generated by the study will be made publicly accessible within 18 to 24 months following the completion of the project studies.
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).
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| Faculdade de Motricidade Humana de Lisboa |
| UNKNOWN |
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| Type 2 Diabetes Guidebook | 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. |
|
| Baseline (T0), 4 months (T1), 10 months (T2). |
| 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. | Baseline (T0), 4 months (T1), 10 months (T2) |
| 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). | Baseline (T0), 4 months (T1), 10 months (T2) |
| 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). | Baseline (T0), 4 months (T1), 10 months (T2) |
| 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). | Baseline (T0), 4 months (T1), 10 months (T2) |
| 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:
| Over the course of each participant's study period (expected to be for 10 months) |
| Acceptability, Appropriateness, and Feasibility of Intervention | The acceptability, appropriateness, and feasibility of the VA|PREVENTION web app will be assessed through the evaluation of:
| 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. |
| 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. | Baseline (T0), 4 months (T1), 10 months (T2) |
| Continuously, with formal assessments at 4 months (T1), 10 months (T2) |
| 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 |
| 21479777 | Background | 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. |
| 34265011 | Background | 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. |
| 18091006 | Background | 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. |
| 28303543 | Background | 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. |
| 32525912 | Background | 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. |
| 12610029 | Background | 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. |
| 32020062 | Background | 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. |
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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