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More Health Less Diabetes

NCT07079722 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Pre-diabetes

Interventions

BEHAVIORAL

Exercise

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.

Sponsors & Collaborators

  • Faculdade de Motricidade Humana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-07-30
Completion
2026-12-20

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079722 on ClinicalTrials.gov