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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 123
- Locations
- 1
Study Overview
Brief Summary
This behavioral intervention study aims to assess physical activity levels and sedentary behavior among individuals with diabetes. It will compare the effectiveness of standard interventions against informational sessions on the benefits of physical activity for achieving changes in behavior and improving quality of life while reducing reliance on healthcare services.
Participants will be divided into 3 groups: one receiving standard care from the diabetology service; one attending three theoretical motor counseling sessions; another engaging in three theoretical motor counseling sessions plus practical counseling supervised by kinesiologist.
The primary objective is to evaluate physical activity levels at 6 and 12 months post-intervention. Secondary objectives include assessing sedentary time, health status, anthropometric measurements, blood pressure, barriers to engaging in physical activity, motivation levels, dietary habits, readiness for lifestyle changes, perceived quality of life, and functional capacities.
Detailed Description
A total of 123 participants, all voluntary and at no cost, will be recruited from the Diabetology clinics of the Complex Structure of Endocrinology and Metabolic Diseases in Perugia. The recruitment process will employ a randomized, non-blinded methodology, enabling the formation of three distinct groups for comparison.
Group 1 will consist of 41 people who have been diagnosed with diabetes mellitus for a minimum of three months. This cohort will receive standard medical care, which encompasses routine monitoring and management of their condition. Alongside this, participants will complete questionnaires designed to assess their health status and lifestyle, as well as undergo evaluations of their functional abilities, which may include tests of strength, mobility, and overall physical capacity. Importantly, members of this group will not receive specific recommendations for engaging in daily physical activity from healthcare providers or kinesiologists. Instead, the guidance provided will be solely theoretical, with no practical motor counseling offered to enhance their physical activity levels.
Group 2 will similarly include 41 people meeting the same three-month diagnostic criteria for diabetes mellitus. These participants will also benefit from standard care, complete questionnaires, and undergo assessments of their functional abilities. However, a key distinction for Group 2 is the provision of recommendations for daily physical activity from both healthcare professionals and kinesiologists. While this group will receive theoretical guidance on the importance of physical activity, they will not receive practical motor counseling to help them implement these recommendations in their daily lives.
Group 3 will feature another set of 41 people, again fulfilling the condition of having a diabetes mellitus diagnosis for no less than three months. In addition to receiving the same standard care, questionnaire administration, and assessments of functional capabilities, participants in this group will also receive recommendations for daily physical activity from their healthcare and kinesiology teams. What sets Group 3 apart is the inclusion of 24 biweekly sessions focused on practical motor counseling, where individuals will engage in structured physical activity programs. This component is designed to provide hands-on, practical guidance that enables participants to actively incorporate physical exercise into their routines, aiming to enhance their overall health and functional abilities.
Through this detailed approach, the study aims to explore the impact of differing levels of prescribed physical activity and support on the functional outcomes of individuals living with diabetes mellitus, contributing valuable insights to the management practices in diabetic care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.