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Interdisciplinary Counselling in DIAbetes (DIA/01)

6 мая 2026 г. обновлено: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

123

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Carmine G Fanelli, Prof.
  • Номер телефона: +39 075 578.4231
  • Электронная почта: carmine.fanelli@unipg.it

Учебное резервное копирование контактов

  • Имя: Roberto Pippi, PhD
  • Номер телефона: +390759668938
  • Электронная почта: roberto.pippi@unipg.it

Места учебы

  • Италия
    • PG
      • Perugia, PG, Италия, 06156
        • Рекрутинг
        • Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Perugia
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Без вмешательства: Group 1 (n = 41)
Standard care (SC)
Экспериментальный: Group 2 (n = 41)
Standard care + theoretical counseling on physical activity
Поведенческий: 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.
Экспериментальный: Group 3 (n = 41)
Standard care + theoretical counseling on physical activity + practical counseling on physical activity
Поведенческий: 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.
Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Total weekly physical activity time
Временное ограничение: 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).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Total weekly walking physical activity time
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At the time of enrollment.
Number of years of patients
At the time of enrollment.
Body weight
Временное ограничение: 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
Временное ограничение: 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)
Waist circumference
Временное ограничение: 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)
Body mass index (BMI)
Временное ограничение: 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).
Fasting glucose
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT)
Временное ограничение: 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)
Creatinine
Временное ограничение: 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
Временное ограничение: 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)
Stages of Change
Временное ограничение: 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).
Barriers to physical activity
Временное ограничение: 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 .
At time of enrollment and follow up (6 and 12 months).
Adherence to the Mediterranean diet
Временное ограничение: 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.
At time of enrollment and follow up (6 and 12 months).
Measures of patient's health-related quality of life
Временное ограничение: 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.
At time of enrollment and follow up (6 and 12 months).
Self-Care, Usual Activities quality of life, and health status
Временное ограничение: 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.
At time of enrollment and follow up (6 and 12 months).
Hand Grip Strength
Временное ограничение: At time of enrollment and follow up (6 and 12 months).
The Hand Grip Strength will be measured with DynX ® dynamometer.
At time of enrollment and follow up (6 and 12 months).
Dynamic muscle strength
Временное ограничение: 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.
At time of enrollment and follow up (6 and 12 months).
Aerobic capacity
Временное ограничение: 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
Total High-Density Lipoprotein (HDL) values
Временное ограничение: 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)
Total Low-Density Lipoprotein (LDL) values
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
Muscle mass value
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
Fat free mass percentage
Временное ограничение: 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
Временное ограничение: 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.
At the time of enrollment and follow-up (6 and 12 months).
Sleep Efficiency percentage
Временное ограничение: 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.
At the time of enrollment and follow-up (6 and 12 months).
Wake After Sleep Onset
Временное ограничение: 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.
At the time of enrollment and follow-up (6 and 12 months).
Sleep Onset Latency time
Временное ограничение: 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.
At the time of enrollment and follow-up (6 and 12 months).
Sleep Fragmentation Index
Временное ограничение: 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.
At the time of enrollment and follow-up (6 and 12 months).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Centro Universitario Ricerca Interdipartimentale Attivita' Motoria

Соавторы

Azienda Ospedaliera di Perugia
University of Perugia, Faculty of Medicine, Department of Internal Medicine

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

12 февраля 2025 г.

Первичное завершение (Действительный)

23 января 2026 г.

Завершение исследования (Оцененный)

31 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

22 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

6 мая 2026 г.

Первый опубликованный (Действительный)

13 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

6 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CET N.2387/25

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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