Interdisciplinary Counselling in DIAbetes

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.

Conditions

• Type 2 Diabetes

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia

  collaborator OTHER

• University of Perugia, Faculty of Medicine, Department of Internal Medicine

  collaborator OTHER

• Centro Universitario Ricerca Interdipartimentale Attivita' Motoria

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-12

Primary Completion

2026-01-23

Completion

2027-12-31

Countries

• Italy

Study Locations