Type 1 Diabetes MellitusNCT07355660
The Effect of a Web-Based Education Program on Eating Habits, Metabolic Control, and Self-Management in Adolescents With Type 1 Diabetes Mellitus and Their Mothers With Irregular Eating Behavior
A study of Type 1 Diabetes Mellitus, run by TC Erciyes University.
Trial summary
The study was planned as a randomized controlled experimental study to investigate the effects of a web-based educational program given to adolescents with diabetes mellitus and their mothers on eating habits, metabolic control, and self-management. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2026to 16 Dec 2026
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- T1DM adolescents and their mothers who have internet access at home,
- have a DEPS-R score of 20 or higher,
- are between the ages of 12 and 18,
- have been diagnosed with T1DM at least one year ago,
- have no other chronic illness other than T1DM, and
- agree to participate in the study
Who cannot join
- Diabetes diagnosis lasted less than one year.
- The adolescent has a chronic condition other than T1DM.
- The adolescent and their mother have cognitive or perceptual disabilities in understanding the website's content.
- Participants who did not complete the training program.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The study was planned as a randomized controlled experimental study to investigate the effects of a web-based educational program given to adolescents with diabetes mellitus and their mothers on eating habits, metabolic control, and self-management.
The prevalence of Type 1 diabetes is increasing worldwide and is reported to be the third most common chronic disease in childhood (Lowes et al., 2015). It is generally accepted that effective management of diabetes requires education for both the patient and the family regarding management components such as blood glucose monitoring, insulin replacement, diet, exercise, and problem-solving strategies (Couch et al., 2008). Since diabetes management requires lifestyle changes, many health professionals recommend providing education to the whole family (Shiel et al., 2023).
Read more
Adolescence is a period of developing autonomy and often means reduced parental involvement; however, an adolescent with Type 1 diabetes is also coping with a serious, life-threatening disease (Polfuss et al., 2015). Increased self-care responsibilities during adolescence create additional complex challenges for the management and treatment of diabetes. Websites providing information about diabetes to adolescents offer problem-solving opportunities and an interactive environment for sharing experiences.
The study population will consist of adolescents and their mothers followed at the Pediatric Endocrinology Outpatient Clinic of Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital. In the first phase of the study, the Descriptive Characteristics and Eating Disorder Behavior Scale (DESPR) will be administered to adolescents and their mothers to identify adolescents with eating disorder behaviors. The sample was determined as 272 adolescents using the G Power program with a margin of error of d=0.2, a margin of error of 0.05, and a 95% confidence interval. For the second phase of the study, adolescents with a DESPR score of 20 or higher will be divided into three groups: Intervention I (Adolescents Only), Intervention II (Adolescents and Mothers), and Control Group (Clinical Practice Routine). The sample size was calculated using the G Power program with a margin of error of d=0.4, a margin of error of 0.05, and an 85% confidence interval, resulting in a total of 72 individuals, with 24 individuals in each group. The groups into which individuals will be placed will be determined using the block randomization method applied on the www.randomizer.org website.
Training Implementation:
Training will be given to two groups: Web-Based Intervention Group I (Adolescents) and Intervention Group II (Adolescents and Mothers). An initial introductory meeting will be held, and training on how to use the web program will be given in a single 40-minute session. Website Preparation: The website will be structured using WordPress, a web-based software development tool that supports most web browsers. Website content will be evaluated using the DISCERN Measurement Tool by a faculty member from the Department of Endocrinology and Metabolic Diseases, three faculty members from the Faculty of Nursing, three Diabetes Education Nurses, and a faculty member from the Department of Nutrition and Dietetics. The researcher will introduce the website to adolescents by explaining its name and how to use it. Individuals in the intervention group will also be given usernames and passwords to access the site. New topics, blog posts, and quizzes related to the topic will be added to the site each week, and a reminder message will be sent to individuals in the intervention group when a new topic is added. The website will include an interface where members can log in to their own pages, enter blood glucose measurements, access training modules, exchange messages, and perform administrative tasks (user lists, monitoring all measurements, and tracking training results). The "Contact" page on the website will allow users to send messages to site administrators. Six menus are planned for the website: "Home", "Our Team", "Blog", "Training", "Surveys", and "Contact". Blog Menu: This will be a space where members can chat with each other and share their experiences. The aim is to encourage members to comment on topics determined by the site administrator and share their experiences. After using the website, everyone will be given the opportunity to comment on the materials provided. Educational materials cover topics such as Type 1 diabetes, nutrition for young people with diabetes, carbohydrate counting, acute complications such as hypoglycemia, long-term complications, physical exercise in diabetes, diabetes treatment, insulin, and continuous glucose monitoring.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Eating habits, Diabetes self-management, Metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating habits, Diabetes self-management, Metabolic controlBehavioural
This study addresses these gaps and offers a unique approach. Initially, unlike existing studies, the goal is to develop a holistic educational model encompassing both adolescents and their mothers. Furthermore, the program will be structured with content specific to disordered eating behaviors, which frequently coexist with Type 1 diabetes. In this respect, the project is one of the few initiatives that address the relationship between eating disorders and metabolic control in a holistic manner. Furthermore, the study is not limited to knowledge or self-management, but conducts a multidimensional analysis by jointly evaluating eating habits, metabolic parameters, and psychosocial indicators. The web-based content will be designed to suit the Turkish cultural context and will also allow for the assessment of the impact of variables such as digital inequality and parental support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group I (Adolescents) | Active comparator | Not described Receives: Behavioral: Eating habits, Diabetes self-management, Metabolic control |
| Intervention Group II (Adolescents and Their Mothers) | Active comparator | Not described Receives: Behavioral: Eating habits, Diabetes self-management, Metabolic control |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescents with Type 1 DM who participated in the web-based training program experienced a decrease in their disordered eating behavior symptom scores.
The Diabetes Eating Disorders Questionnaire and the Dutch Eating Behavior Questionnaire will be used to assess disordered eating behavior. Measurements are planned to be taken at baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3) time points before the program. A change of at least 20% in the relevant scale scores between T0 and T3, or a statistically significant change with p<0.05, is defined as the success criterion.
Measured: AFTER 6 MONTHS
Secondary outcomes (2)
Decrease in HbA1c values of adolescents with Type 1 DM who participated in the web-based education program.
HbA1c laboratory results will be evaluated at time points T0 (baseline), T2 (3 months), and T3 (6 months). A change of at least 0.5 points in mean HbA1c compared to baseline or a significant change (p<0.05) in the percentage of achieving a clinically significant target (e.g., ≤7.5% as defined by the study) was defined as the success criterion.
Measured: AFTER 6 MONTHS
Decrease in diabetes self-management skills scores (T1DDYÖS) of adolescents with Type 1 DM who participated in the web-based education program.
The T1DDYÖÖ scale will be evaluated at time points T0, T1, and T3 (6 months). A change of at least 15% in scale scores from T0 to T3, or a statistically significant change with p<0.05, is defined as the success criterion.
Measured: AFTER 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start16 Jan 2026 (estimated)
- Primary completion16 Jun 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the first phase of the study, adolescents with disordered eating behaviors will be identified by administering the Descriptive Characteristics and Disordered Eating Behavior Scale (DESPR) to adolescents and their mothers. The sample for this phase was determined to be 272 adolescents using the G Power program with a d=0.2, a 0.05 margin of error, and a 95% confidence interval. For the second phase, adolescents with a DESPR score of 20 or higher will be divided into three groups: Intervention I (Adolescents Only), Intervention II (Adolescents and Their Mothers), and the Control Group (Clinical Practice Routine). The G Power program calculated that 24 individuals would be included in each group. This study will employ a block-randomized pretest-posttest design. The experimental group will receive a web-based education program, while the control group will receive only standard education and routine care.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gökhan GÖNÜL, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355660
- Sponsor's protocol ID
- ERU-SBF-GG-01
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I don't have detailed information on this subject. Therefore, I'm undecided at the moment.
Publications
Pinsker JE, Nguyen C, Young S, Fredericks GJ, Chan D. A pilot project for improving paediatric diabetes outcomes using a website: the Pediatric Diabetes Education Portal. J Telemed Telecare. 2011;17(5):226-30. doi: 10.1258/jtt.2010.100812. Epub 2011 May 12.
PubMed 21565846Couch R, Jetha M, Dryden DM, Hooten N, Liang Y, Durec T, Sumamo E, Spooner C, Milne A, O'Gorman K, Klassen TP. Diabetes education for children with type 1 diabetes mellitus and their families. Evid Rep Technol Assess (Full Rep). 2008 Apr;(166):1-144.
PubMed 18620470Lowes L, Eddy D, Channon S, McNamara R, Robling M, Gregory JW; DEPICTED study team. The experience of living with type 1 diabetes and attending clinic from the perception of children, adolescents and carers: analysis of qualitative data from the DEPICTED study. J Pediatr Nurs. 2015 Jan-Feb;30(1):54-62. doi: 10.1016/j.pedn.2014.09.006. Epub 2014 Sep 28.
PubMed 25308399Polfuss M, Babler E, Bush LL, Sawin K. Family Perspectives of Components of a Diabetes Transition Program. J Pediatr Nurs. 2015 Sep-Oct;30(5):748-56. doi: 10.1016/j.pedn.2015.05.010. Epub 2015 Jun 15.
PubMed 26088279Shiel EV, Hemingway S, Burton K, King N. Self-management of type 1 diabetes in young adults: Is it impeded by aspects of everyday life? A scoping review. Diabetes Metab Syndr. 2023 Dec;17(12):102918. doi: 10.1016/j.dsx.2023.102918. Epub 2023 Nov 30.
PubMed 38064953
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Web-Based Education Program on Eating Habits, Metabolic Control, and Self-Management in Adolescents With Type 1 Diabetes Mellitus and Their Mothers With Irregular Eating Behavior
- ClinicalTrials.gov ID
- NCT07355660
- Acronym / sponsor ID
- ERU-SBF-GG-01
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 16 Jan 2026 (estimated)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 21 Jan 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 study was planned as a randomized controlled experimental study to investigate the effects of a web-based educational program given to adolescents with diabetes mellitus and their mothers on eating habits, metabolic control, and self-management.
The prevalence of Type 1 diabetes is increasing worldwide and is reported to be the third most common chronic disease in childhood (Lowes et al., 2015). It is generally accepted that effective management of diabetes requires education for both the patient and the family regarding management components such as blood glucose monitoring, insulin replacement, diet, exercise, and problem-solving strategies (Couch et al., 2008). Since diabetes management requires lifestyle changes, many health professionals recommend providing education to the whole family (Shiel et al., 2023).
Adolescence is a period of developing autonomy and often means reduced parental involvement; however, an adolescent with Type 1 diabetes is also coping with a serious, life-threatening disease (Polfuss et al., 2015). Increased self-care responsibilities during adolescence create additional complex challenges for the management and treatment of diabetes. Websites providing information about diabetes to adolescents offer problem-solving opportunities and an interactive environment for sharing experiences.
The study population will consist of adolescents and their mothers followed at the Pediatric Endocrinology Outpatient Clinic of Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital. In the first phase of the study, the Descriptive Characteristics and Eating Disorder Behavior Scale (DESPR) will be administered to adolescents and their mothers to identify adolescents with eating disorder behaviors. The sample was determined as 272 adolescents using the G Power program with a margin of error of d=0.2, a margin of error of 0.05, and a 95% confidence interval. For the second phase of the study, adolescents with a DESPR score of 20 or higher will be divided into three groups: Intervention I (Adolescents Only), Intervention II (Adolescents and Mothers), and Control Group (Clinical Practice Routine). The sample size was calculated using the G Power program with a margin of error of d=0.4, a margin of error of 0.05, and an 85% confidence interval, resulting in a total of 72 individuals, with 24 individuals in each group. The groups into which individuals will be placed will be determined using the block randomization method applied on the www.randomizer.org website.
Training Implementation:
Training will be given to two groups: Web-Based Intervention Group I (Adolescents) and Intervention Group II (Adolescents and Mothers). An initial introductory meeting will be held, and training on how to use the web program will be given in a single 40-minute session. Website Preparation: The website will be structured using WordPress, a web-based software development tool that supports most web browsers. Website content will be evaluated using the DISCERN Measurement Tool by a faculty member from the Department of Endocrinology and Metabolic Diseases, three faculty members from the Faculty of Nursing, three Diabetes Education Nurses, and a faculty member from the Department of Nutrition and Dietetics. The researcher will introduce the website to adolescents by explaining its name and how to use it. Individuals in the intervention group will also be given usernames and passwords to access the site. New topics, blog posts, and quizzes related to the topic will be added to the site each week, and a reminder message will be sent to individuals in the intervention group when a new topic is added. The website will include an interface where members can log in to their own pages, enter blood glucose measurements, access training modules, exchange messages, and perform administrative tasks (user lists, monitoring all measurements, and tracking training results). The "Contact" page on the website will allow users to send messages to site administrators. Six menus are planned for the website: "Home", "Our Team", "Blog", "Training", "Surveys", and "Contact". Blog Menu: This will be a space where members can chat with each other and share their experiences. The aim is to encourage members to comment on topics determined by the site administrator and share their experiences. After using the website, everyone will be given the opportunity to comment on the materials provided. Educational materials cover topics such as Type 1 diabetes, nutrition for young people with diabetes, carbohydrate counting, acute complications such as hypoglycemia, long-term complications, physical exercise in diabetes, diabetes treatment, insulin, and continuous glucose monitoring.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In the first phase of the study, adolescents with disordered eating behaviors will be identified by administering the Descriptive Characteristics and Disordered Eating Behavior Scale (DESPR) to adolescents and their mothers. The sample for this phase was determined to be 272 adolescents using the G Power program with a d=0.2, a 0.05 margin of error, and a 95% confidence interval. For the second phase, adolescents with a DESPR score of 20 or higher will be divided into three groups: Intervention I (Adolescents Only), Intervention II (Adolescents and Their Mothers), and the Control Group (Clinical Practice Routine). The G Power program calculated that 24 individuals would be included in each group. This study will employ a block-randomized pretest-posttest design. The experimental group will receive a web-based education program, while the control group will receive only standard education and routine care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group I (Adolescents) | Active comparator | Behavioral: Eating habits, Diabetes self-management, Metabolic control |
| Intervention Group II (Adolescents and Their Mothers) | Active comparator | Behavioral: Eating habits, Diabetes self-management, Metabolic control |
| Control group | No intervention | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- T1DM adolescents and their mothers who have internet access at home,
- have a DEPS-R score of 20 or higher,
- are between the ages of 12 and 18,
- have been diagnosed with T1DM at least one year ago,
- have no other chronic illness other than T1DM, and
Key exclusion criteria (4 listed)
- Diabetes diagnosis lasted less than one year.
- The adolescent has a chronic condition other than T1DM.
- The adolescent and their mother have cognitive or perceptual disabilities in understanding the website's content.
- Participants who did not complete the training program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating habits, Diabetes self-management, Metabolic controlThis study addresses these gaps and offers a unique approach. Initially, unlike existing studies, the goal is to develop a holistic educational model encompassing both adolescents and their mothers. Furthermore, the program will be structured with content specific to disordered eating behaviors, which frequently coexist with Type 1 diabetes. In this respect, the project is one of the few initiatives that address the relationship between eating disorders and metabolic control in a holistic manner. Furthermore, the study is not limited to knowledge or self-management, but conducts a multidimensional analysis by jointly evaluating eating habits, metabolic parameters, and psychosocial indicators. The web-based content will be designed to suit the Turkish cultural context and will also allow for the assessment of the impact of variables such as digital inequality and parental support. | Behavioural | Intervention Group I (Adolescents), Intervention Group II (Adolescents and Their Mothers) |
Primary outcome
Adolescents with Type 1 DM who participated in the web-based training program experienced a decrease in their disordered eating behavior symptom scores.
Time frame: AFTER 6 MONTHS
The Diabetes Eating Disorders Questionnaire and the Dutch Eating Behavior Questionnaire will be used to assess disordered eating behavior. Measurements are planned to be taken at baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3) time points before the program. A change of at least 20% in the relevant scale scores between T0 and T3, or a statistically significant change with p<0.05, is defined as the success criterion.
2 secondary outcomes
Decrease in HbA1c values of adolescents with Type 1 DM who participated in the web-based education program.
Time frame: AFTER 6 MONTHS
Decrease in diabetes self-management skills scores (T1DDYÖS) of adolescents with Type 1 DM who participated in the web-based education program.
Time frame: AFTER 6 MONTHS
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 21 Jan 2026.
- Results publication: PubMed 21565846Pinsker JE, Nguyen C, Young S, Fredericks GJ, Chan D. A pilot project for improving paediatric diabetes outcomes using a website: the Pediatric Diabetes Education Portal. J Telemed Telecare. 2011;17(5):226-30. doi: 10.1258/jtt.2010.100812. Epub 2011 May 12.
- Results publication: PubMed 18620470Couch R, Jetha M, Dryden DM, Hooten N, Liang Y, Durec T, Sumamo E, Spooner C, Milne A, O'Gorman K, Klassen TP. Diabetes education for children with type 1 diabetes mellitus and their families. Evid Rep Technol Assess (Full Rep). 2008 Apr;(166):1-144.
- Results publication: PubMed 25308399Lowes L, Eddy D, Channon S, McNamara R, Robling M, Gregory JW; DEPICTED study team. The experience of living with type 1 diabetes and attending clinic from the perception of children, adolescents and carers: analysis of qualitative data from the DEPICTED study. J Pediatr Nurs. 2015 Jan-Feb;30(1):54-62. doi: 10.1016/j.pedn.2014.09.006. Epub 2014 Sep 28.
- Results publication: PubMed 26088279Polfuss M, Babler E, Bush LL, Sawin K. Family Perspectives of Components of a Diabetes Transition Program. J Pediatr Nurs. 2015 Sep-Oct;30(5):748-56. doi: 10.1016/j.pedn.2015.05.010. Epub 2015 Jun 15.
- Results publication: PubMed 38064953Shiel EV, Hemingway S, Burton K, King N. Self-management of type 1 diabetes in young adults: Is it impeded by aspects of everyday life? A scoping review. Diabetes Metab Syndr. 2023 Dec;17(12):102918. doi: 10.1016/j.dsx.2023.102918. Epub 2023 Nov 30.
- The Diabetes AtlasLink provided by the sponsor.
- American Diabetes AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I don't have detailed information on this subject. Therefore, I'm undecided at the moment.
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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.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus, run by TC Erciyes University.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Gökhan GÖNÜL (+90 545 411 53 87, ggonul@nny.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescents with Type 1 DM who participated in the web-based training program experienced a decrease in their disordered eating behavior symptom scores. (time frame: AFTER 6 MONTHS). 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 NCT07355660, which also lists 5 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 21 Jan 2026.