Type 2 DiabetesDIA/01NCT07583355
Interdisciplinary Counselling in DIAbetes
A study testing Theoretical Counseling on Physical Activity (TCPA) in people with Type 2 Diabetes, run by Centro Universitario Ricerca Interdipartimentale Attivita' Motoria at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Theoretical Counseling on Physical Activity (TCPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- the presence of severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate PA;
- refusal or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Perugia
Perugia, PG, 06156
Roberto Pippi, PhD, +390759668938, servizio.curiamo@unipg.it
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Theoretical Counseling on Physical Activity (TCPA), Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA)
- Keywords
- diabetes mellitus, physical activity, sedentary behavior, exercise intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theoretical Counseling on Physical Activity (TCPA)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Group 1 (n = 41) | No intervention | Standard care (SC) |
| Group 2 (n = 41) | Experimental | Standard care + theoretical counseling on physical activity Receives: Behavioral: Theoretical Counseling on Physical Activity (TCPA) |
| Group 3 (n = 41) | Experimental | Standard care + theoretical counseling on physical activity + practical counseling on physical activity Receives: Behavioral: Theoretical Counseling on Physical Activity (TCPA); Behavioral: Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Secondary outcomes (38)
Total weekly walking physical activity time
Total physical activity (PA) time in a week, expressed in min/week, spent in walking.
This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Total weekly moderate physical activity time
Total physical activity (PA) time in a week, expressed in min/week, spent in moderate-intensity PA.
This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Total weekly vigorous physical activity time
Total physical activity (PA) time in a week, expressed in min/week, spent in vigorous-intensity PA.
This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Sedentary time
Daily time spent in sedentary activities (defined as activities with a energy expenditure <1.5 Metabolic Equivalent of Task-hours). This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Age
Number of years of patients
Measured: At the time of enrollment.
Body weight
Weight (kg) assessed using a calibrate medical scale
Measured: At the time of enrollment and follow-up (6 and 12 months).
Height
Height (m) assessed using a medical stadiometer.
Measured: At the enrollment, and during follow up (6 and 12 months)
Waist circumference
Waist circumference (cm) will be measured using a medical tape
Measured: At the enrollment, and during follow up (6 and 12 months)
Body mass index (BMI)
Body mass index (kg/m2) will be calculated as weight (kg) divided by the square of height (meters).
Measured: At the time of enrollment and follow-up (6 and 12 months).
Fasting glucose
Blood glucose value expressed in mg/dl
Measured: At the enrollment, and during follow up (6 and 12 months)
Glycated hemoglobin (HbA1c)
Mean of blood glucose in the last three months, expressed in percentage
Measured: At the enrollment, and during follow up (6 and 12 months)
Total blood cholesterol value
Total cholesterol value in blood, expressed in mg/dL
Measured: At the enrollment, and during follow up (6 and 12 months)
Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT)
SGOT and SGPT blood values
Measured: At the enrollment, and during follow up (6 and 12 months)
Creatinine
creatinine blood values, expresseg in mg/dL
Measured: At the enrollment, and during follow up (6 and 12 months)
Blood pressure
Systolic and diastolic blood pressure (mmHg) values will be measured with a digital column sphygmomanometer for professional blood pressure measurement.
Measured: At the enrollment, and during follow up (6 and 12 months)
Stages of Change
Stages of Change will be studied using an eight point item questionnaire specifically used for exercise, developed as part of the PACE (Patient-centered Assessment and Counseling for Activity) project.
It is based on the Transthetic Model of Prochaska and Di Clemente and helps understand where a person is with respect to physical activity.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Barriers to physical activity
This is a 32-item instrument used to identify specific barriers to adherence and maintenance physical activity. Items are grouped into key categories that influence behavior: personal barriers (e.g., laziness, lack of motivation, tiredness, feelings of shame); physical/health barriers (e.g., pain, fear of injury, feeling too fat); environmental/external barriers (e.g., weather conditions, lack of safe places, traffic); social/economic barriers (lack of family support, excessive costs). The list of barriers comes from integrating the "PACE" protocol adapted for diabetic or obese people .
Measured: At time of enrollment and follow up (6 and 12 months).
Adherence to the Mediterranean diet
Eating habits and adherence to the principles of the Mediterranean diet will be assessed by administering the 14-Item Mediterranean Diet Assessment Tool questionnaire.
Measured: At time of enrollment and follow up (6 and 12 months).
Measures of patient's health-related quality of life
The 36-Item Short Form Survey (SF-36) evaluates eight health domains (physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), providing scores for both physical and mental health functioning. Each item is scored on a 0 to 100 range: a lower score indicates higher impairment and a higher score indicates better health.
Measured: At time of enrollment and follow up (6 and 12 months).
Self-Care, Usual Activities quality of life, and health status
Movement Ability, Personal Care, usual Activities (i.e. Work, Study, Home), Pain or Discomfort, and Anxiety or Depression will be assessed using the EuroQol-5Dimensions-3levels questionnaire. For each dimensions, participants will choose between 3 levels of severity (indicated by numbers 1= No problems; 2=Some / Moderate problems; 3=Extreme problems / Inability to perform the action). Finally, the EQ-VAS will be used to ask participants about health status over the past year. This questionnaire is usually accompanied by a Visual Analog Scale (VAS), a sort of "thermometer" graduated from 0 to 100 on which the patient is asked to mark how they rate their health today.
Measured: At time of enrollment and follow up (6 and 12 months).
Hand Grip Strength
The Hand Grip Strength will be measured with DynX ® dynamometer.
Measured: At time of enrollment and follow up (6 and 12 months).
Dynamic muscle strength
Dynamic muscle strength will be assessed by estimating one repetition maximum by submaximal upper and lower limb strength tests, performed at natural load or with the aid of isotonic machines, using Brzycki's 1-RM prediction equation.
Measured: At time of enrollment and follow up (6 and 12 months).
Aerobic capacity
Aerobic capacity will be estimated using the 6 Minutes Walking Test.
Measured: At the time of enrolment and at 6 and 12 months
Total High-Density Lipoprotein (HDL) values
Total HDL values in blood, expressed in mg/dL
Measured: At the enrollment, and during follow up (6 and 12 months)
Total Low-Density Lipoprotein (LDL) values
Total LDL values in blood, expressed in mg/dL
Measured: At the enrollment, and during follow up (6 and 12 months)
Triglycerides values
Triglycerides value in blood, expressed as mg/dL
Measured: At the time of enrollment and follow-up (6 and 12 months).
Fat mass value
Body fat mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
Measured: At time of enrollment and follow up (6 and 12 months).
Fat free mass value
Body fat free mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
Measured: At time of enrollment and follow up (6 and 12 months).
Muscle mass value
Muscle mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
Measured: At time of enrollment and follow up (6 and 12 months).
Total body water value
Total body water, expressed in percentage, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
Measured: At time of enrollment and follow up (6 and 12 months).
Basal metabolism value
Basal metabolism rate, expressed in kcal, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
Measured: At time of enrollment and follow up (6 and 12 months).
Fat mass percentage
Fat mass percentage assessed using an air plethysmograph (BOD POD® Composition System; COSMED, Albano Laziale, Italy).
Measured: At time of enrollment and follow up (6 and 12 months).
Fat free mass percentage
Fat free mass percentage assessed using an air plethysmograph (BOD POD® Composition System; COSMED, Albano Laziale, Italy).
Measured: At time of enrollment and follow up (6 and 12 months).
Total Sleep Time
Total Sleep Time, expressed in minutes, measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Sleep Efficiency percentage
Sleep Efficiency is a a ratio, expressed as a percentage, representing the proportion of time spent asleep relative to the total time spent in bed. It is calculated as (Total Sleep Time / Time in Bed) × 100. Higher values indicate more consolidated and restorative sleep. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Wake After Sleep Onset
Wake After Sleep Onset is the total amount of time spent awake after initially falling asleep, until the final awakening. It reflects the degree of sleep fragmentation during the night. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Sleep Onset Latency time
Sleep Onset Latency, expressed in minutes, is the time it takes to transition from full wakefulness to sleep after lying down. Longer latency may indicate difficulty initiating sleep. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Sleep Fragmentation Index
Sleep Fragmentation Index is an index that measures the frequency of sleep-wake transitions, expressed as a percentage. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type.
Measured: At the time of enrollment and follow-up (6 and 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start12 Feb 2025
- Primary completion23 Jan 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, Randomized, non-blinded, intervention study
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario Ricerca Interdipartimentale Attivita' Motoria
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Perugia, University of Perugia, Faculty of Medicine, Department of Internal Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583355
- Sponsor's protocol ID
- CET N.2387/25
- Acronym
- DIA/01
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07583355
- Acronym / sponsor ID
- DIA/01 / CET N.2387/25
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes mellitus, physical activity, sedentary behavior, exercise intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Centro Universitario Ricerca Interdipartimentale Attivita' MotoriaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Perugia, University of Perugia, Faculty of Medicine, Department of Internal Medicine
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Controlled, Randomized, non-blinded, intervention study
| Arm | Type | Receives |
|---|---|---|
| Group 1 (n = 41) | No intervention | –Standard care (SC) |
| Group 2 (n = 41) | Experimental | Behavioral: Theoretical Counseling on Physical Activity (TCPA)Standard care + theoretical counseling on physical activity |
| Group 3 (n = 41) | Experimental | Behavioral: Theoretical Counseling on Physical Activity (TCPA), Behavioral: Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA)Standard care + theoretical counseling on physical activity + practical counseling on physical activity |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- the presence of severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate PA;
- refusal or inability to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 2 (n = 41), Group 3 (n = 41) |
| 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. | Behavioural | Group 3 (n = 41) |
Primary outcome
Total weekly physical activity time
Time frame: 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.
38 secondary outcomes
Total weekly walking physical activity time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Total weekly moderate physical activity time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Total weekly vigorous physical activity time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Sedentary time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Age
Time frame: At the time of enrollment.
Body weight
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Height
Time frame: At the enrollment, and during follow up (6 and 12 months)
Waist circumference
Time frame: At the enrollment, and during follow up (6 and 12 months)
Body mass index (BMI)
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Fasting glucose
Time frame: At the enrollment, and during follow up (6 and 12 months)
Glycated hemoglobin (HbA1c)
Time frame: At the enrollment, and during follow up (6 and 12 months)
Total blood cholesterol value
Time frame: At the enrollment, and during follow up (6 and 12 months)
Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT)
Time frame: At the enrollment, and during follow up (6 and 12 months)
Creatinine
Time frame: At the enrollment, and during follow up (6 and 12 months)
Blood pressure
Time frame: At the enrollment, and during follow up (6 and 12 months)
Stages of Change
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Barriers to physical activity
Time frame: At time of enrollment and follow up (6 and 12 months).
Adherence to the Mediterranean diet
Time frame: At time of enrollment and follow up (6 and 12 months).
Measures of patient's health-related quality of life
Time frame: At time of enrollment and follow up (6 and 12 months).
Self-Care, Usual Activities quality of life, and health status
Time frame: At time of enrollment and follow up (6 and 12 months).
Hand Grip Strength
Time frame: At time of enrollment and follow up (6 and 12 months).
Dynamic muscle strength
Time frame: At time of enrollment and follow up (6 and 12 months).
Aerobic capacity
Time frame: At the time of enrolment and at 6 and 12 months
Total High-Density Lipoprotein (HDL) values
Time frame: At the enrollment, and during follow up (6 and 12 months)
Total Low-Density Lipoprotein (LDL) values
Time frame: At the enrollment, and during follow up (6 and 12 months)
Triglycerides values
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Fat mass value
Time frame: At time of enrollment and follow up (6 and 12 months).
Fat free mass value
Time frame: At time of enrollment and follow up (6 and 12 months).
Muscle mass value
Time frame: At time of enrollment and follow up (6 and 12 months).
Total body water value
Time frame: At time of enrollment and follow up (6 and 12 months).
Basal metabolism value
Time frame: At time of enrollment and follow up (6 and 12 months).
Fat mass percentage
Time frame: At time of enrollment and follow up (6 and 12 months).
Fat free mass percentage
Time frame: At time of enrollment and follow up (6 and 12 months).
Total Sleep Time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Sleep Efficiency percentage
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Wake After Sleep Onset
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Sleep Onset Latency time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Sleep Fragmentation Index
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Type 2 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theoretical Counseling on Physical Activity (TCPA) in people with Type 2 Diabetes, run by Centro Universitario Ricerca Interdipartimentale Attivita' Motoria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmine G Fanelli, Prof. (+39 075 578.4231, carmine.fanelli@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weekly physical activity time (time frame: At the time of enrollment and follow-up (6 and 12 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.