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Recruiting Not applicable

Interdisciplinary Counselling in DIAbetes

NCT07583355 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02-12
Last updated
2026-05-13

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Theoretical Counseling on Physical Activity (TCPA)Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA)

Theoretical Counseling on Physical Activity (TCPA): Participant wil be involved in: * Routine assessments: Anthropometric (weight, height, waist circumference) and hematobiochemical parameters (e.g., glycemic and lipid profiles), and systolic and diastolic blood pressure. * General information + administration of the IPAQ, PACE, Barriers, Mediterranean Diet, and Quality of Life questionnaires. * Body Composition Assessment: BMI, fat mass (FM), fat free mass (FFM), muscle mass, total body water (TBW) and basal metabolism rate (BMR). * Non-diagnostic assessment of functional abilities: submaximal tests of strength, muscular endurance, and flexibility. * Only 3 sessions (1 per month) of TCPA: the Kinesiologist will inform the patient about the guidelines and the various types of PA, as well as their dose-dependent effects.

Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA): Participant wil be involved in: * Routine assessments: Anthropometric (weight, height, waist circumference) and hematobiochemical parameters (e.g., glycemic and lipid profiles), and systolic and diastolic blood pressure. * General information + administration of the IPAQ, PACE, Barriers, Mediterranean Diet, and Quality of Life questionnaires. * Body Composition Assessment: BMI, fat mass (FM), fat free mass (FFM), muscle mass, total body water (TBW) and basal metabolism rate (BMR). * Non-diagnostic assessment of functional abilities: submaximal tests of strength, muscular endurance, and flexibility. * Only 3 sessions (1 per month) of TCPA: the Kinesiologist will inform the patient about the guidelines and the various types of PA, as well as their dose-dependent effects. * PCPA: supervised mixed physical activity program (cardiovascular + resistance) lasting 3 months, with 2 sessions per week.

Study 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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
80 Years
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.

Primary outcome measure(s)

  • Total weekly physical activity time — At the time of enrollment and follow-up (6 and 12 months).
    Total physical activity (PA) time in a week, expressed in min/week. It result from the sum of time spent in moderate-intensity PA + time spent in vigorous-intensity PA + time spent in walking. This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.

Trial sites (1)

FacilityCityRegionStatus
Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Perugia Perugia PG Recruiting

More Centro Universitario Ricerca Interdipartimentale Attivita' Motoria trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07583355 on ClinicalTrials.gov ↗ ← All trials in Italy