NCT07079722 More Health Less Diabetes

Trial Parameters

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Brief Summary

The "More Health, Less Diabetes" project is a hybrid randomized controlled trial to prevent type 2 diabetes in individuals at risk through structured exercise and lifestyle education. While exercise benefits for people with diabetes are well-documented, evidence remains limited on the effectiveness and cost-effectiveness of in-person and home-based exercise programs in a prediabetic population. This study aims to understand the clinical and cost-effectiveness of a three-arm RCT (online, in-person, and a control group) in people at high risk of developing T2DM. This 12-month program includes six months of supervised exercise (3 times/week) and a six-month follow-up. During the first six months, both intervention groups will attend educational sessions to improve health literacy and promote healthy habits. The primary outcome will be 2h glycemia in an oral glucose tolerance test. Secondary outcomes include other aspects of glycemic control (HbA1c, fasting glycemia, HOMA-IR, Matsuda index), 24-hour movement, body composition, vascular health, physical fitness, and cost-effectiveness using a social return on investment approach.

Eligibility Criteria

Inclusion Criteria: 1. High or Very High Risk according to the FINDRISC questionnaire; 2. Analytical confirmation of no diagnostic criteria for Diabetes, following a type 2 Diabetes risk assessment; 3. Committed to making lifestyle changes to manage diabetes; 4. Internet access; 5. Availability to participate in the program as required (schedule, location); Exclusion Criteria: 1. pregnancy (self-report/medical record); 2. Inability to use digital devices 3. Presence of abnormalities on exercise stress test.

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