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

Egas Moniz - Cooperativa de Ensino Superior, CRL280 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

USF Cova da Piedade

Almada, Almada, Portugal

NOT_YET_RECRUITING

USF Rosinha

Seixal, Amora, Portugal

NOT_YET_RECRUITING

USF Charneca do Sol

Almada, Charneca Da Caparica, Portugal

NOT_YET_RECRUITING

USF Inovar

Almada, Corroios, Portugal

NOT_YET_RECRUITING

USF Saúde Laranjeiro

Almada, Fernão Ferro, Portugal

NOT_YET_RECRUITING

USF Vista Tejo

Almada, Monte Da Caparica, Portugal

NOT_YET_RECRUITING

Farmácia Alvide

Alcabideche, Portugal

RECRUITING

Farmácia da Ramalha

Almada, Portugal

RECRUITING

Farmácia Largo do Coreto

Almada, Portugal

RECRUITING

Farmácia Nuno Álvares

Almada, Portugal

RECRUITING

...and 6 more locations

Outcomes

Primary Outcomes

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.

Time frame: Baseline (T0), 4 months (T1), 10 months (T2)

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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).

Time frame: Baseline (T0), 4 months (T1), 10 months (T2)

Change in Dietary Behaviours

Time frame: 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).

Time frame: 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: 1. Number of complete interactions with Ema for physical activity and dietary behaviours over the intervention period; 2. Number of complete topics answered in the educational menus; 3. Number of visits to the dashboard: (i) educative menus usage data ; (ii) self-monitoring and goal progress features; and (iii) feature showing the number of interactions with Ema; 4. Length of use of: i) interactions with Ema; ii) Educative Menus; and iii) Dashboard for physical activity and dietary behaviours; 5. Frequency of use of: i) interactions with Ema; ii) Educative Menus; and iii) Dashboard for physical activity and dietary behaviours 6. Number of secondary users that access the dashboard 7. Number of visits of secondary users to the dashboard;

Time frame: 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: 1. Acceptability, Appropriateness and Feasibility questionnaire responded by participants/users, secondary users and managers; Each section of the questionnaire has 4 items, responded on a 5-point likert scale, ranging from completely disagree to completely agree. 2. Qualitative data from interviews with primary and secondary users. 3. Qualitative date from interviews with managers of Primary Care Units and Community pharmacies; These will be telephone interviews, and thematic saturation will be used to determine the size of the samples with a minimum of 20 interviews planned for primary users, and a minimum of 10 participants for each of the remaining samples is envisaged.

Time frame: 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.

Time frame: Baseline (T0), 4 months (T1), 10 months (T2)

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

Overview

Conditions

Interventions

Eligibility

Locations (16)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts