Interdisciplinary Counselling in DIAbetes (DIA/01)
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Carmine G Fanelli, Prof.
- Numero di telefono: +39 075 578.4231
- Email: carmine.fanelli@unipg.it
Backup dei contatti dello studio
- Nome: Roberto Pippi, PhD
- Numero di telefono: +390759668938
- Email: roberto.pippi@unipg.it
Luoghi di studio
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PG
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Perugia, PG, Italia, 06156
- Reclutamento
- Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Perugia
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Contatto:
- Roberto Pippi, PhD
- Numero di telefono: +390759668938
- Email: servizio.curiamo@unipg.it
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Group 1 (n = 41)
Standard care (SC)
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Sperimentale: Group 2 (n = 41)
Standard care + theoretical counseling on physical activity
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Participant wil be involved in:
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Sperimentale: Group 3 (n = 41)
Standard care + theoretical counseling on physical activity + practical counseling on physical activity
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Participant wil be involved in:
Participant wil be involved in:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total weekly physical activity time
Lasso di tempo: 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. |
At the time of enrollment and follow-up (6 and 12 months).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total weekly walking physical activity time
Lasso di tempo: 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. |
At the time of enrollment and follow-up (6 and 12 months).
|
|
Total weekly moderate physical activity time
Lasso di tempo: 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. |
At the time of enrollment and follow-up (6 and 12 months).
|
|
Total weekly vigorous physical activity time
Lasso di tempo: 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. |
At the time of enrollment and follow-up (6 and 12 months).
|
|
Sedentary time
Lasso di tempo: 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.
|
At the time of enrollment and follow-up (6 and 12 months).
|
|
Age
Lasso di tempo: At the time of enrollment.
|
Number of years of patients
|
At the time of enrollment.
|
|
Body weight
Lasso di tempo: At the time of enrollment and follow-up (6 and 12 months).
|
Weight (kg) assessed using a calibrate medical scale
|
At the time of enrollment and follow-up (6 and 12 months).
|
|
Height
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Height (m) assessed using a medical stadiometer.
|
At the enrollment, and during follow up (6 and 12 months)
|
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Waist circumference
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Waist circumference (cm) will be measured using a medical tape
|
At the enrollment, and during follow up (6 and 12 months)
|
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Body mass index (BMI)
Lasso di tempo: 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).
|
At the time of enrollment and follow-up (6 and 12 months).
|
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Fasting glucose
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Blood glucose value expressed in mg/dl
|
At the enrollment, and during follow up (6 and 12 months)
|
|
Glycated hemoglobin (HbA1c)
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Mean of blood glucose in the last three months, expressed in percentage
|
At the enrollment, and during follow up (6 and 12 months)
|
|
Total blood cholesterol value
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Total cholesterol value in blood, expressed in mg/dL
|
At the enrollment, and during follow up (6 and 12 months)
|
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Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT)
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
SGOT and SGPT blood values
|
At the enrollment, and during follow up (6 and 12 months)
|
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Creatinine
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
creatinine blood values, expresseg in mg/dL
|
At the enrollment, and during follow up (6 and 12 months)
|
|
Blood pressure
Lasso di tempo: 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.
|
At the enrollment, and during follow up (6 and 12 months)
|
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Stages of Change
Lasso di tempo: 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. |
At the time of enrollment and follow-up (6 and 12 months).
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Barriers to physical activity
Lasso di tempo: 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 .
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At time of enrollment and follow up (6 and 12 months).
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Adherence to the Mediterranean diet
Lasso di tempo: At time of enrollment and follow up (6 and 12 months).
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Eating habits and adherence to the principles of the Mediterranean diet will be assessed by administering the 14-Item Mediterranean Diet Assessment Tool questionnaire.
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At time of enrollment and follow up (6 and 12 months).
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Measures of patient's health-related quality of life
Lasso di tempo: 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.
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At time of enrollment and follow up (6 and 12 months).
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Self-Care, Usual Activities quality of life, and health status
Lasso di tempo: 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.
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At time of enrollment and follow up (6 and 12 months).
|
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Hand Grip Strength
Lasso di tempo: At time of enrollment and follow up (6 and 12 months).
|
The Hand Grip Strength will be measured with DynX ® dynamometer.
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At time of enrollment and follow up (6 and 12 months).
|
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Dynamic muscle strength
Lasso di tempo: 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.
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At time of enrollment and follow up (6 and 12 months).
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Aerobic capacity
Lasso di tempo: At the time of enrolment and at 6 and 12 months
|
Aerobic capacity will be estimated using the 6 Minutes Walking Test.
|
At the time of enrolment and at 6 and 12 months
|
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Total High-Density Lipoprotein (HDL) values
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Total HDL values in blood, expressed in mg/dL
|
At the enrollment, and during follow up (6 and 12 months)
|
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Total Low-Density Lipoprotein (LDL) values
Lasso di tempo: At the enrollment, and during follow up (6 and 12 months)
|
Total LDL values in blood, expressed in mg/dL
|
At the enrollment, and during follow up (6 and 12 months)
|
|
Triglycerides values
Lasso di tempo: At the time of enrollment and follow-up (6 and 12 months).
|
Triglycerides value in blood, expressed as mg/dL
|
At the time of enrollment and follow-up (6 and 12 months).
|
|
Fat mass value
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
|
Fat free mass value
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
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Muscle mass value
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
|
Total body water value
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
|
Basal metabolism value
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
|
Fat mass percentage
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
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Fat free mass percentage
Lasso di tempo: 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).
|
At time of enrollment and follow up (6 and 12 months).
|
|
Total Sleep Time
Lasso di tempo: 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.
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At the time of enrollment and follow-up (6 and 12 months).
|
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Sleep Efficiency percentage
Lasso di tempo: 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.
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At the time of enrollment and follow-up (6 and 12 months).
|
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Wake After Sleep Onset
Lasso di tempo: 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.
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At the time of enrollment and follow-up (6 and 12 months).
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Sleep Onset Latency time
Lasso di tempo: 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.
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At the time of enrollment and follow-up (6 and 12 months).
|
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Sleep Fragmentation Index
Lasso di tempo: 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.
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At the time of enrollment and follow-up (6 and 12 months).
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Comportamento
- Malattie nutrizionali e metaboliche
- Diabete mellito, tipo 2
- Diabete mellito
- Attività motoria
- Comportamento sedentario
- Amministrazione dei servizi sanitari
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Indicatori di qualità, assistenza sanitaria
- Standard di cura
Altri numeri di identificazione dello studio
- CET N.2387/25
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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