- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Buket Akinci, Professor
- Número de teléfono: +905056415692
- Correo electrónico: barbuket@hotmail.com
Ubicaciones de estudio
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Zeytinburnu
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Istanbul, Zeytinburnu, Turquía (Türkiye), 34015
- Reclutamiento
- Biruni University
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Contacto:
- Buket Akinci, Professor
- Número de teléfono: +905056415692
- Correo electrónico: barbuket@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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 . |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Physical activity level
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fasting Blood Glucose
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-BİAEK/15-23
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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