Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Perugia
Perugia, PG, 06156, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT07583355
Interdisciplinary Counselling in DIAbetes
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
25 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Theoretical Counseling on Physical Activity (TCPA)
BehavioralParticipant 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)
BehavioralParticipant 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.
Primary outcomes
-
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.
Secondary outcomes
-
Total weekly walking 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, spent in walking.
This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
-
Total weekly moderate 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, spent in moderate-intensity PA.
This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
-
Total weekly vigorous 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, spent in vigorous-intensity PA.
This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy.
-
Sedentary time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
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.
-
Age
Time frame: At the time of enrollment.
Number of years of patients
-
Body weight
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Weight (kg) assessed using a calibrate medical scale
-
Height
Time frame: At the enrollment, and during follow up (6 and 12 months)
Height (m) assessed using a medical stadiometer.
-
Waist circumference
Time frame: At the enrollment, and during follow up (6 and 12 months)
Waist circumference (cm) will be measured using a medical tape
-
Body mass index (BMI)
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Body mass index (kg/m2) will be calculated as weight (kg) divided by the square of height (meters).
-
Fasting glucose
Time frame: At the enrollment, and during follow up (6 and 12 months)
Blood glucose value expressed in mg/dl
-
Glycated hemoglobin (HbA1c)
Time frame: At the enrollment, and during follow up (6 and 12 months)
Mean of blood glucose in the last three months, expressed in percentage
-
Total blood cholesterol value
Time frame: At the enrollment, and during follow up (6 and 12 months)
Total cholesterol value in blood, expressed in mg/dL
-
Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT)
Time frame: At the enrollment, and during follow up (6 and 12 months)
SGOT and SGPT blood values
-
Creatinine
Time frame: At the enrollment, and during follow up (6 and 12 months)
creatinine blood values, expresseg in mg/dL
-
Blood pressure
Time frame: At the enrollment, and during follow up (6 and 12 months)
Systolic and diastolic blood pressure (mmHg) values will be measured with a digital column sphygmomanometer for professional blood pressure measurement.
-
Stages of Change
Time frame: At the time of enrollment and follow-up (6 and 12 months).
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.
-
Barriers to physical activity
Time frame: At time of enrollment and follow up (6 and 12 months).
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 .
-
Adherence to the Mediterranean diet
Time frame: At time of enrollment and follow up (6 and 12 months).
Eating habits and adherence to the principles of the Mediterranean diet will be assessed by administering the 14-Item Mediterranean Diet Assessment Tool questionnaire.
-
Measures of patient's health-related quality of life
Time frame: At time of enrollment and follow up (6 and 12 months).
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.
-
Self-Care, Usual Activities quality of life, and health status
Time frame: At time of enrollment and follow up (6 and 12 months).
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.
-
Hand Grip Strength
Time frame: At time of enrollment and follow up (6 and 12 months).
The Hand Grip Strength will be measured with DynX ® dynamometer.
-
Dynamic muscle strength
Time frame: At time of enrollment and follow up (6 and 12 months).
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.
-
Aerobic capacity
Time frame: At the time of enrolment and at 6 and 12 months
Aerobic capacity will be estimated using the 6 Minutes Walking Test.
-
Total High-Density Lipoprotein (HDL) values
Time frame: At the enrollment, and during follow up (6 and 12 months)
Total HDL values in blood, expressed in mg/dL
-
Total Low-Density Lipoprotein (LDL) values
Time frame: At the enrollment, and during follow up (6 and 12 months)
Total LDL values in blood, expressed in mg/dL
-
Triglycerides values
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Triglycerides value in blood, expressed as mg/dL
-
Fat mass value
Time frame: At time of enrollment and follow up (6 and 12 months).
Body fat mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
-
Fat free mass value
Time frame: At time of enrollment and follow up (6 and 12 months).
Body fat free mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
-
Muscle mass value
Time frame: At time of enrollment and follow up (6 and 12 months).
Muscle mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
-
Total body water value
Time frame: At time of enrollment and follow up (6 and 12 months).
Total body water, expressed in percentage, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
-
Basal metabolism value
Time frame: At time of enrollment and follow up (6 and 12 months).
Basal metabolism rate, expressed in kcal, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan).
-
Fat mass percentage
Time frame: At time of enrollment and follow up (6 and 12 months).
Fat mass percentage assessed using an air plethysmograph (BOD POD® Composition System; COSMED, Albano Laziale, Italy).
-
Fat free mass percentage
Time frame: At time of enrollment and follow up (6 and 12 months).
Fat free mass percentage assessed using an air plethysmograph (BOD POD® Composition System; COSMED, Albano Laziale, Italy).
-
Total Sleep Time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
Total Sleep Time, expressed in minutes, measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type.
-
Sleep Efficiency percentage
Time frame: At the time of enrollment and follow-up (6 and 12 months).
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.
-
Wake After Sleep Onset
Time frame: At the time of enrollment and follow-up (6 and 12 months).
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.
-
Sleep Onset Latency time
Time frame: At the time of enrollment and follow-up (6 and 12 months).
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.
-
Sleep Fragmentation Index
Time frame: At the time of enrollment and follow-up (6 and 12 months).
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Carmine G Fanelli, Prof.
CONTACT
Roberto Pippi, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Centro Universitario Ricerca Interdipartimentale Attivita' Motoria
Other
Collaborators
- Azienda Ospedaliera di Perugia
- University of Perugia, Faculty of Medicine, Department of Internal Medicine
Registry information
Official study 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
Acronym: DIA/01
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- May 13, 2026
- Registry last updated
- May 13, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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