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

April 28, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Type 1 Diabetes Mellitus

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Buket Akinci, Professor
Phone Number: +905056415692
Email: barbuket@hotmail.com

Study Locations

Turkey (Türkiye)
- Zeytinburnu
  - Istanbul, Zeytinburnu, Turkey (Türkiye), 34015
    - Recruiting
    - Biruni University
    - Contact:
      
      Buket Akinci, Professor
      
      Phone Number: +905056415692
      
      Email: barbuket@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 .

Group / Cohort

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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed at baseline
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.	At baseline
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.	At baseline
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.	At baseline
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.	7 days
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 (%).	At baseline
Sedentary Time Time Frame: 7 days	Time spent in sedentary behavior will be assessed using accelerometer data and expressed in minutes per day.	7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2026

Primary Completion (Estimated)

September 13, 2026

Study Completion (Estimated)

September 13, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)