- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07568028
Examining Multilevel Factors Affecting Participation in Physical Activity Among Adolescents With Type 1 Diabetes Using the Socio-Ecological Model
The goal of this observational study is to examine the multilevel factors influencing physical activity participation in adolescents with Type 1 diabetes (T1D) within the framework of the Socio-Ecological Model (SEM). Physical activity is a multidimensional behavior shaped by individual, interpersonal, institutional, community, and policy-level influences, and it plays a critical role in diabetes management, metabolic health, and overall well-being in youth with T1D.
The main questions it aims to answer are:
Do factors at the individual, interpersonal, institutional, community, and policy levels of the Socio-Ecological Model significantly influence physical activity participation, social participation, and diabetes management in adolescents with Type 1 diabetes? Which modifiable barriers and facilitators at these multiple levels are associated with higher or lower levels of physical activity?
Participants diagnosed with Type 1 diabetes will complete questionnaires assessing their daily living activities, exercise habits, social participation, psychosocial characteristics, and perceived social and environmental support. Objective measurements related to circadian rhythm patterns and glycemic control will also be collected. The study will analyze how multilevel socio-ecological factors are associated with physical activity behavior, social engagement, and diabetes management outcomes.
The findings are expected to provide a comprehensive biopsychosocial understanding of physical activity behaviors in adolescents with Type 1 diabetes and to inform the development of supportive, school- and community-based intervention strategies aimed at improving quality of life, self-efficacy, psychological resilience, and sustainable participation in physical activity.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Buket Akinci, Professor
- Номер телефона: +905056415692
- Электронная почта: barbuket@hotmail.com
Места учебы
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Zeytinburnu
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Istanbul, Zeytinburnu, Турция (Туркие), 34015
- Рекрутинг
- Biruni University
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Контакт:
- Buket Akinci, Professor
- Номер телефона: +905056415692
- Электронная почта: barbuket@hotmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Diagnosed with Type 1 diabetes at least 1 year prior to enrollment,
- Aged between 9 and 18 years,
- Currently attending school in Istanbul,
- Willing to participate in the study (with voluntary consent),
- HbA1c value ≥ 8% within the past year,
- Reported glucose metabolism biomarkers,
- Sufficient cognitive ability to understand and complete the questionnaires,
- Under regular medical follow-up and using at least one glucose monitoring device.
Exclusion Criteria:
- Lack of parental consent,
- Presence of additional neurological, motor, or cognitive disorders,
- Inadequate mental status or diagnosis of moderate to severe intellectual disability,
- Presence of systemic comorbid diseases,
- Failure to report HbA1c data.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Adolescents with Type 1 Diabetes
This cohort consists of adolescents aged 9-18 years diagnosed with Type 1 diabetes for at least one year and currently receiving regular medical follow-up in Istanbul. Participants meet predefined inclusion criteria, including documented HbA1c values ≥8% within the previous year and reported glycemic biomarkers. All participants use at least one glucose monitoring device and are capable of completing study questionnaires. This is an observational, cross-sectional study. No experimental intervention is applied. Participants will complete validated questionnaires assessing physical activity, daily living activities, social participation, psychosocial factors, and socio-ecological determinants. Objective measures related to glycemic control . |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical activity level
Временное ограничение: 7 days
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Physical activity level will be objectively assessed using a wearable accelerometer worn on the dominant arm for seven consecutive days.
PAL will be calculated as the ratio of total energy expenditure to basal metabolic rate and expressed as a unitless value.
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7 days
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Fasting Blood Glucose
Временное ограничение: Assessed at baseline
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Fasting blood glucose levels will be measured over seven consecutive days using glucose meters or continuous glucose monitoring (CGM) systems and expressed in mg/dL.
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Assessed at baseline
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Social Participation
Временное ограничение: At baseline
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Social Participation: Social participation will be measured using the CASP, a scale assessing participation at home, school, and in the community.
Scores will be transformed to a 0-100 scale, with higher scores indicating greater participation.
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At baseline
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Diabetes Self-Efficacy
Временное ограничение: At baseline
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Self-efficacy will be assessed using the self-efficacy subscale of the Multidimensional Diabetes Questionnaire.
Scores range from 0 to 100, with higher scores indicating greater perceived self-efficacy.
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At baseline
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Chronotype
Временное ограничение: At baseline
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Chronotype will be assessed using the Childhood Chronotype Questionnaire (CCTQ), a parent-reported instrument adapted from the Munich Chronotype Questionnaire and the Morningness-Eveningness Scale for Children.
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At baseline
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Daily Step Count
Временное ограничение: 7 days
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Daily step count will be measured using a wearable accelerometer worn on the dominant arm for seven consecutive days and expressed as steps per day.
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7 days
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Glycated Hemoglobin (HbA1c)
Временное ограничение: At baseline
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Glycemic control will be assessed using glycated hemoglobin (HbA1c) levels obtained from venous blood samples and expressed as percentage (%).
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At baseline
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Sedentary Time
Временное ограничение: 7 days
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Time spent in sedentary behavior will be assessed using accelerometer data and expressed in minutes per day.
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7 days
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Naar-King S, Podolski CL, Ellis DA, Frey MA, Templin T. Social ecological model of illness management in high-risk youths with type 1 diabetes. J Consult Clin Psychol. 2006 Aug;74(4):785-9. doi: 10.1037/0022-006X.74.4.785.
- Bogaert L, Dirinck E, Calders P, Helleputte S, Lapauw B, Marlier J, Verbestel V, De Craemer M. Explanatory variables of objectively measured physical activity, sedentary behaviour and sleep in adults with type 1 diabetes: A systematic review. Diabet Med. 2025 Mar;42(3):e15473. doi: 10.1111/dme.15473. Epub 2024 Nov 21.
- Bamuya C, Correia JC, Brady EM, Beran D, Harrington D, Damasceno A, Crampin AM, Magaia A, Levitt N, Davies MJ, Hadjiconstantinou M. Use of the socio-ecological model to explore factors that influence the implementation of a diabetes structured education programme (EXTEND project) inLilongwe, Malawi and Maputo, Mozambique: a qualitative study. BMC Public Health. 2021 Jul 8;21(1):1355. doi: 10.1186/s12889-021-11338-y.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2024-BİAEK/15-23
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .