Interdisciplinary counseling for people with type 2 diabetes
Multidisciplinary Counselling Intervention for the Medium-long Term Adoption of a Physically Active Lifestyle and the Reduction of Sedentary Behaviour in People With Diabetes Mellitus
This project tests whether adding theoretical and practical exercise counseling to standard diabetes care helps adults with type 2 diabetes be more active and sit less.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 123 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Centro Universitario Ricerca Interdipartimentale Attivita' Motoria Academic / other |
| Locations | 1 site (Perugia, PG) |
| Trial ID | NCT07583355 on ClinicalTrials.gov |
What this trial studies
This randomized, non-blinded study will enroll 123 adults with type 2 diabetes at the University Hospital of Perugia and assign them to one of three groups: standard care alone, three theoretical motor counseling sessions plus standard care, or three theoretical sessions plus practical, supervised counseling by a kinesiologist. Physical activity levels are the primary outcome, measured at baseline and again at 6 and 12 months, with secondary outcomes including sedentary time, anthropometrics, blood pressure, dietary habits, motivation, barriers to activity, readiness to change, perceived quality of life, and healthcare use. Participants complete questionnaires and functional tests and those in the practical arm receive supervised motor counseling to translate recommendations into daily behavior. The trial focuses on adults aged 25–80 with insufficient weekly physical activity and a BMI between 18.5 and 40.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25–80 with type 2 diabetes diagnosed at least three months ago, who walk independently, have a BMI between 18.5 and 40, and do less than 150 minutes per week of moderate-intensity physical activity.
Not a fit: People with severe cardiovascular, neurological, or musculoskeletal conditions that make physical activity unsafe, those unable or unwilling to give informed consent, or those already meeting physical activity guidelines are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help people with type 2 diabetes increase weekly physical activity, reduce sedentary time, improve quality of life, and potentially reduce use of healthcare services.
How similar studies have performed: Previous trials of exercise counseling and supervised exercise programs in type 2 diabetes have shown improvements in activity levels and some metabolic and quality-of-life outcomes, though head-to-head comparisons of theoretical versus combined practical counseling remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of T2DM of at least 3 months; * age between 25 and 80 years; * engagement in insufficient PA (\< 150 minutes per week of moderate-intensity PA, according to WHO guidelines); * ability to walk independently; * 18.5 \< BMI (kg/m²) \< 40. Exclusion Criteria: * the presence of severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate PA; * refusal or inability to provide written informed consent.
Where this trial is running
Perugia, PG
- Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Perugia — Perugia, Pg, Italy (Recruiting)
Study contacts
- Study coordinator: Carmine G Fanelli, Prof.
- Email: carmine.fanelli@unipg.it
- Phone: +39 075 578.4231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.