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

NCT07568028 | Recruiting DMC

• 1 other identifier: 2024-BİAEK/15-23
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus; Socio-Ecological Model; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical activity level

  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

Secondary Outcomes (7)

• Fasting Blood Glucose

  Assessed at baseline

• Social Participation

  At baseline

• Diabetes Self-Efficacy

  At baseline

• Chronotype

  At baseline

• Daily Step Count

  7 days

Study Arms (1)

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 .

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 RESULT

• 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.

  PMID: 34238258 RESULT

• 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 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Central Study Contacts

Buket Akinci, Professor

CONTACT

+905056415692; barbuket@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: May 5, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): September 13, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

TU (1)