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Recruiting NCT07568028

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

— Observational Type 1 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 9 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • Physical activity level [Time frame: 7 days]
Secondary outcome measures (7)
  • Fasting Blood Glucose [Time frame: Assessed at baseline]
  • Social Participation [Time frame: At baseline]
  • Diabetes Self-Efficacy [Time frame: At baseline]
  • Chronotype [Time frame: At baseline]
  • Daily Step Count [Time frame: 7 days]
  • Glycated Hemoglobin (HbA1c) [Time frame: At baseline]
  • Sedentary Time [Time frame: 7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Biruni University — Istanbul

Publications

  • 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. PMID 39570861
  • 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/ PMID 34238258
  • 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. PMID 16881786

Identifiers

NCT: NCT07568028 · 2024-BİAEK/15-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗