RecruitingNot ApplicableNCT07079722

More Health Less Diabetes

Educational Program for Type 2 Diabetes Prevention With Integrated Physical Exercise: Digital and In-Person Approach


Sponsor

Faculdade de Motricidade Humana

Enrollment

90 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called 'More Health Less Diabetes' — is testing a digital program that helps people at high risk for Type 2 diabetes make lifestyle changes (such as diet and exercise) to prevent or delay the onset of the disease. Participants use online tools and support to work toward healthier habits. **You may be eligible if...** - You scored high or very high on a diabetes risk questionnaire (FINDRISC) - Blood tests confirm you do not yet have diabetes - You are committed to making lifestyle changes - You have internet access and can attend the program sessions **You may NOT be eligible if...** - You are pregnant - You are unable to use digital devices - You have an abnormal result on an exercise stress test Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise

This project is a randomized controlled trial (RCT) with three distinct groups: a control group (CG), an online intervention group (OIG), and an in-person intervention group (IIG). The OIG will receive online educational sessions and structured home-based exercises, while the IIG will participate in in-person educational sessions and supervised physical exercise. The control group will not participate in educational sessions or structured physical exercise.


Locations(1)

Faculty of Human Kinetics

Lisbon, Lisbon District, Portugal

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NCT07079722


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