Type 1 Diabetes MellitusNCT07568028
Examining Multilevel Factors Affecting Participation in Physical Activity Among Adolescents With Type 1 Diabetes Using the Socio-Ecological Model
An observational study of Type 1 Diabetes Mellitus, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 13 Sep 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul, Zeytinburnu, 34015
Buket Akinci, Professor, +905056415692, barbuket@hotmail.com
About this study
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:
Read more
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
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (7)
Fasting Blood Glucose
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.
Measured: Assessed at baseline
Social Participation
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.
Measured: At baseline
Diabetes Self-Efficacy
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.
Measured: At baseline
Chronotype
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.
Measured: At baseline
Daily Step Count
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.
Measured: 7 days
Glycated Hemoglobin (HbA1c)
Glycemic control will be assessed using glycated hemoglobin (HbA1c) levels obtained from venous blood samples and expressed as percentage (%).
Measured: At baseline
Sedentary Time
Time spent in sedentary behavior will be assessed using accelerometer data and expressed in minutes per day.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start2 Jan 2026
- Primary completion13 Sep 2026 (estimated)
- Study completion13 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568028
- Sponsor's protocol ID
- 2024-BİAEK/15-23
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39570861Bamuya 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.
PubMed 34238258Naar-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.
PubMed 16881786
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Multilevel Factors Affecting Participation in Physical Activity Among Adolescents With Type 1 Diabetes Using the Socio-Ecological Model
- ClinicalTrials.gov ID
- NCT07568028
- Acronym / sponsor ID
- 2024-BİAEK/15-23
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Socio-Ecological Model, Physical Activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 13 Sep 2026 (estimated)
- Study completion
- 13 Sep 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 . |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 39570861Bogaert 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.
- Results publication: PubMed 34238258Bamuya 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.
- Results publication: PubMed 16881786Naar-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buket Akinci, Professor (+905056415692, barbuket@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07568028, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.