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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• High or Very High Risk according to the FINDRISC questionnaire;

• Analytical confirmation of no diagnostic criteria for Diabetes, following a type 2 Diabetes risk assessment;

• Committed to making lifestyle changes to manage diabetes;

• Internet access;

• Availability to participate in the program as required (schedule, location);

Locations
Other Locations
Portugal
Faculty of Human Kinetics
RECRUITING
Lisbon
Contact Information
Primary
João Magalhães Associate Professor, Doctor
joaomagalhaes@fmh.ulisboa.pt
967 832 539
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 90
Treatments
Active_comparator: Control group
The control group will not participate in educational sessions or structured physical exercise.
Experimental: In-person intervention group (IIG).
The IIG will participate in in-person educational sessions and supervised physical exercise
Experimental: Online intervention group (OIG)
The OIG will receive online educational sessions and structured home-based exercises
Related Therapeutic Areas
Sponsors
Leads: Faculdade de Motricidade Humana

This content was sourced from clinicaltrials.gov