Diabetes Self ManagementNCT05763303
Impact of an Interventional Program on Self-Management
A study testing educational program in people with Diabetes Self Management, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial study is to assess the effect of an interventional program on diabetes self-management and therefore on effective glycemic control among diabetic students in Assuit university Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Self Management
- What is being tested?
- educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2023to 1 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Confirmed cases of diabetes mellitus (IDD" type I" \& NIDD "type II") among Assiut University students
Who cannot join
- Diabetic students with severe disability or handicapped
- Diabetic students known to have another health problem make him un tolerable to do exercise such as cardiovascular disease, bronchial asthma
- Diabetic students with speech and hearing difficulties.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine / Assiut university
Asyut
Ramadan Ali, 01112586630, alidrramadan@yahoo.com
Medhat Araby, proph, 01000032910, Medhatelaraby75@yahoo.com
About this study
Official title: Impact of an Interventional Program on Self-Management Among Students With Diabetes in Assiut University
The goal of this randomized clinical trial study is to assess the effect of an interventional program on diabetes self-management and therefore on effective glycemic control among diabetic students in Assuit university
Read the detailed description
- To formulate a strategy aiming to reduce the burden of diabetes morbidity \& mortality;
- To determine degree of self-management in diabetic participants
- To identify the obstacles facing the diabetic students to achieve an accepted self-management;
- To assess the impact of the interventional program on overcoming such obstacles; and
- To assess the impact of diabetes self-management on glycemic control among diabetic students in Assiut University All university students who suffer from diabetes and attend the study's clinic seeking medical treatment during a full academic year (2023/2024) with inclusion and exclusion criteria are recruited. The sample is divided into 150 cases for intervention group and 150 for control group (traditional care), by Systemic random technique. All participants will be exposed to Questionnaires for assessment of Diabetes Self-management, and measurements of glycated hemoglobin (HbA1c), body weight, height, at base line, three months, and 6 months after the end of the program.
- Conditions
- Diabetes Self Management
- Being tested
- educational program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational programOther
interventional program consists of educational part and training part in case of agreement of participants
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | received interventional program which will consist of :
1. -The educational part: the health education intervention will be in the form of brief counselling five sessions (about half an hour for each session at 1-week intervals) which are introduced after data collection and blood analysis by simplified manner, in the study's clinic.
2. Training part: We will invite every participant to join this part of the program which will be performed in the fitness center of the faculty of physical education, Assiut University. The entire duration of the 8-week exercise training program is closely supervised by 2 qualified personnel. The exercise session includes running or walking on treadmill, and cycling on bicycle ergometer, about 30 minutes, 3 times per week, Receives: Other: educational program |
| control group | Other | traditional care: the participants will received traditional care in health facility but nothing by researcher Receives: Other: educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change in Perceived Obstacles to diabetes self-management that faced by participants
by short version of the diabetic obstacle questionnaire.
Measured: at base line, three months and six months after the end of the program.
assessment of Change in Diabetes Self-management
by diabetes self-management questionnaire,
Measured: at base line, three months and six months after the end of the program.
assessment of change in measurements of glycated hemoglobin (HbA1c)
by blood analysis to measure (HbA1c)
Measured: at base line, three months and six months after the end of the program.
Secondary outcomes (1)
assessment of change in measurement of body mass index (BMI)
by measurement of weight in kilograms and height in meters and use formula: (BMI) = weight in kilograms ÷ ( height in meter × height in meter)
Measured: at base line, three months and six months after the end of the program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start25 Oct 2023
- Primary completion15 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Self ManagementStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramadan Ali Hamza, Assiut University
- Investigators
- Mohammad Hassan Qayed, Chair, Study chair, Assiut UniversityManal El-Sayed EzzEl-Dine Abdel-Mooty, director, Study director, Internal Medicine - Assiut faculty of MedicineEmad Shaban Ali Hassan, director, Study director, Department of Sports Health Sciences, Faculty of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763303
- Sponsor's protocol ID
- Diabetes Self Management
- Status last verified
- Jun 2025
- First submitted
- 10 Feb 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Interventional Program on Self-Management Among Students With Diabetes in Assiut University
- ClinicalTrials.gov ID
- NCT05763303
- Acronym / sponsor ID
- Diabetes Self Management
- Conditions
- Diabetes Self Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 10 Mar 2023 (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 randomized clinical trial study is to assess the effect of an interventional program on diabetes self-management and therefore on effective glycemic control among diabetic students in Assuit university
Detailed description
- To formulate a strategy aiming to reduce the burden of diabetes morbidity \& mortality;
- To determine degree of self-management in diabetic participants
- To identify the obstacles facing the diabetic students to achieve an accepted self-management;
- To assess the impact of the interventional program on overcoming such obstacles; and
- To assess the impact of diabetes self-management on glycemic control among diabetic students in Assiut University All university students who suffer from diabetes and attend the study's clinic seeking medical treatment during a full academic year (2023/2024) with inclusion and exclusion criteria are recruited. The sample is divided into 150 cases for intervention group and 150 for control group (traditional care), by Systemic random technique. All participants will be exposed to Questionnaires for assessment of Diabetes Self-management, and measurements of glycated hemoglobin (HbA1c), body weight, height, at base line, three months, and 6 months after the end of the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: educational programreceived interventional program which will consist of : 1. -The educational part: the health education intervention will be in the form of brief counselling five sessions (about half an hour for each session at 1-week intervals) which are introduced after data collection and blood analysis by simplified manner, in the study's clinic. 2. Training part: We will invite every participant to join this part of the program which will be performed in the fitness center of the faculty of physical education, Assiut University. The entire duration of the 8-week exercise training program is closely supervised by 2 qualified personnel. The exercise session includes running or walking on treadmill, and cycling on bicycle ergometer, about 30 minutes, 3 times per week, |
| control group | Other | Other: educational programtraditional care: the participants will received traditional care in health facility but nothing by researcher |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Confirmed cases of diabetes mellitus (IDD" type I" \& NIDD "type II") among Assiut University students
Key exclusion criteria (3 listed)
- Diabetic students with severe disability or handicapped
- Diabetic students known to have another health problem make him un tolerable to do exercise such as cardiovascular disease, bronchial asthma
- Diabetic students with speech and hearing difficulties.
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 |
|---|---|---|
| educational programinterventional program consists of educational part and training part in case of agreement of participants | Other | control group, intervention group |
Primary outcome
assessment of change in Perceived Obstacles to diabetes self-management that faced by participants
Time frame: at base line, three months and six months after the end of the program.
by short version of the diabetic obstacle questionnaire.
assessment of Change in Diabetes Self-management
Time frame: at base line, three months and six months after the end of the program.
by diabetes self-management questionnaire,
assessment of change in measurements of glycated hemoglobin (HbA1c)
Time frame: at base line, three months and six months after the end of the program.
by blood analysis to measure (HbA1c)
1 secondary outcome
assessment of change in measurement of body mass index (BMI)
Time frame: at base line, three months and six months after the end of the program.
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 8 Jun 2025.
- Individual participant dataSharing planned: No
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Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program
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Effects of a Researcher-Designed Diabetes Self-Management App on Self-Management Obstacles, Self-Efficacy, and Physiological Indicators in Type 2 Diabetes
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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.
Mohammad Hassan Qayed, Chair study chair
Assiut University
Manal El-Sayed EzzEl-Dine Abdel-Mooty, director study director
Internal Medicine - Assiut faculty of Medicine
Emad Shaban Ali Hassan, director study director
Department of Sports Health Sciences, Faculty of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program in people with Diabetes Self Management, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 3 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 8 Jun 2025. 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 Egypt. 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 Ramadan Ai, Investigato (01112586630, alidrrmadan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change in Perceived Obstacles to diabetes self-management that faced by participants (time frame: at base line, three months and six months after the end of the program.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.