Biruni University
Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07568028
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.
Interested in participating?
Request Info9 year–18 year
All sexes
Observational
Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 7 days
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.
Time frame: Assessed at baseline
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.
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: 7 days
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.
Time frame: At baseline
Glycemic control will be assessed using glycated hemoglobin (HbA1c) levels obtained from venous blood samples and expressed as percentage (%).
Time frame: 7 days
Time spent in sedentary behavior will be assessed using accelerometer data and expressed in minutes per day.
Contact information is provided by the study sponsor or research team.
Biruni University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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