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Examining Multilevel Factors Affecting Participation in Physical Activity Among Adolescents With Type 1 Diabetes Using the Socio-Ecological Model

2026年4月28日 更新者:Buket AKINCI、Biruni University

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.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

55

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Zeytinburnu
      • Istanbul、Zeytinburnu、土耳其(türkiye)、34015
        • 招聘中
        • Biruni University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population consists of adolescents aged 9-18 years who have been diagnosed with Type 1 diabetes and are currently attending school in Istanbul.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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 .

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Physical activity level
大体时间: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.
7 days

次要结果测量

结果测量
措施说明
大体时间
Fasting Blood Glucose
大体时间: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.
Assessed at baseline
Social Participation
大体时间: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.
At baseline
Diabetes Self-Efficacy
大体时间: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.
At baseline
Chronotype
大体时间: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.
At baseline
Daily Step Count
大体时间: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.
7 days
Glycated Hemoglobin (HbA1c)
大体时间:At baseline
Glycemic control will be assessed using glycated hemoglobin (HbA1c) levels obtained from venous blood samples and expressed as percentage (%).
At baseline
Sedentary Time
大体时间:7 days
Time spent in sedentary behavior will be assessed using accelerometer data and expressed in minutes per day.
7 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月2日

初级完成 (估计的)

2026年9月13日

研究完成 (估计的)

2026年9月13日

研究注册日期

首次提交

2026年2月13日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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