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Идёт набор NCT07583355

Interdisciplinary Counselling in DIAbetes

Без фазы С лечением Type 2 Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Theoretical Counseling on Physical Activity (TCPA), Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA).
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes. Базовые параметры: 25 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

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.

Вмешательства

  • Поведенческое 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-diagnos
  • Поведенческое 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-diagnos

Первичные конечные точки

  • Total weekly physical activity time [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
Вторичные конечные точки (12)
  • Total weekly walking physical activity time [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
  • Total weekly moderate physical activity time [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
  • Total weekly vigorous physical activity time [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
  • Sedentary time [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
  • Age [Срок оценки: At the time of enrollment.]
  • Body weight [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
  • Height [Срок оценки: At the enrollment, and during follow up (6 and 12 months)]
  • Waist circumference [Срок оценки: At the enrollment, and during follow up (6 and 12 months)]
  • Body mass index (BMI) [Срок оценки: At the time of enrollment and follow-up (6 and 12 months).]
  • Fasting glucose [Срок оценки: At the enrollment, and during follow up (6 and 12 months)]
  • Glycated hemoglobin (HbA1c) [Срок оценки: At the enrollment, and during follow up (6 and 12 months)]
  • Total blood cholesterol value [Срок оценки: At the enrollment, and during follow up (6 and 12 months)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • Diabetes Center of the Section of Endocrinology and Metabolism, University Hospital of Per — Perugia

Идентификаторы

NCT: NCT07583355 · CET N.2387/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗