More Health Less Diabetes
ConditionPre-diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFaculdade de Motricidade Humana
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
pregnancy (self-report/medical record);
Inability to use digital devices
Presence of abnormalities on exercise stress test.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralThis 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: In-person intervention group (IIG).Experimental treatment 1 intervention
Group C: Online intervention group (OIG)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-hour glucose tolerance test (OGTT)
Biochemical assessments will be conducted through primary healthcare centers. Participants will undergo clinical analyses of a 2-hour glucose tolerance test (OGTT) after ingesting 75g of glucose at baseline, after six months, and after one year.
Time frame
1 yearSecondary outcomes
1
Height in centimeters
Participants' height will be measured with a precision of 0.1 cm, using a scale with an integrated stadiometer (Seca, Hamburg, Germany). Measurements will be collected at baseline, six months, and one year.
Time frame
1 year2
Weight in kilograms
Participants' weight will be measured with a precision of 0.01 kg, using a scale with an integrated stadiometer (Seca, Hamburg, Germany). Measurements will be collected at baseline, six months, and one year.
Time frame
1 year3
Body Mass Index
Body Mass Index (BMI) will be calculated using the formula \[weight (kg)/height² (m²)\]. Measurements will be collected at baseline, six months, and one year.
Time frame
1 year4
Effectiveness of the program
The primary effectiveness outcome will be the change in 2-hour glucose OGTT levels.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov