Interdisciplinary Counselling in DIAbetes

NCT07583355 | Recruiting

• 1 other identifier: CET N.2387/25
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes mellitus; physical activity; sedentary behavior; exercise intervention

Outcome Measures

Primary Outcomes (1)

• Total weekly physical activity time

  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.

  At the time of enrollment and follow-up (6 and 12 months).

Secondary Outcomes (38)

• Total weekly walking physical activity time

  At the time of enrollment and follow-up (6 and 12 months).

• Total weekly moderate physical activity time

  At the time of enrollment and follow-up (6 and 12 months).

• Total weekly vigorous physical activity time

  At the time of enrollment and follow-up (6 and 12 months).

• Sedentary time

  At the time of enrollment and follow-up (6 and 12 months).

• Age

  At the time of enrollment.

Study Arms (3)

Group 1 (n = 41)

NO INTERVENTION

Standard care (SC)

Group 2 (n = 41)

EXPERIMENTAL

Standard care + theoretical counseling on physical activity

Behavioral: Theoretical Counseling on Physical Activity (TCPA)

Group 3 (n = 41)

EXPERIMENTAL

Standard care + theoretical counseling on physical activity + practical counseling on physical activity

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

Interventions

Theoretical Counseling on Physical Activity (TCPA) BEHAVIORAL

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.

Group 2 (n = 41); Group 3 (n = 41)

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

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.

Group 3 (n = 41)

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \< BMI (kg/m²) \< 40.

You may not qualify if:

• the presence of severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate PA;
• refusal or inability to provide written informed consent.

Sponsors & Collaborators

• Centro Universitario Ricerca Interdipartimentale Attivita' Motoria: lead
• Azienda Ospedaliera di Perugia: collaborator
• University of Perugia, Faculty of Medicine, Department of Internal Medicine: collaborator

Study Sites (1)

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

Perugia, PG, 06156, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity; Sedentary Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Carmine G Fanelli, Prof.

CONTACT

+39 075 578.4231; carmine.fanelli@unipg.it

Roberto Pippi, PhD

CONTACT

+390759668938; roberto.pippi@unipg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, Randomized, non-blinded, intervention study

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 13, 2026
• Study Start: February 12, 2025
• Primary Completion: January 23, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

IT (1)