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NCT Number: 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.

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

Location status: Recruiting

Location contact

Buket Akinci, Professor

CONTACT

[email protected]

+905056415692

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Physical activity level

    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.

Secondary outcomes

  1. Fasting Blood Glucose

    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.

  2. Social Participation

    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.

  3. Diabetes Self-Efficacy

    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.

  4. Chronotype

    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.

  5. Daily Step Count

    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.

  6. Glycated Hemoglobin (HbA1c)

    Time frame: At baseline

    Glycemic control will be assessed using glycated hemoglobin (HbA1c) levels obtained from venous blood samples and expressed as percentage (%).

  7. Sedentary Time

    Time frame: 7 days

    Time spent in sedentary behavior will be assessed using accelerometer data and expressed in minutes per day.

Study contacts

Contact information is provided by the study sponsor or research team.

Buket Akinci, Professor

CONTACT

[email protected]

+905056415692

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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