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

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.

Eligibility

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.

Conditions3

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