Clinical trial NCT05763303: Impact of an Interventional Program on Self-Management
Official title: Impact of an Interventional Program on Self-Management Among Students With Diabetes in Assiut University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Self Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Detailed description: 1. To formulate a strategy aiming to reduce the burden of diabetes morbidity \& mortality;
2. To determine degree of self-management in diabetic participants
3. To identify the obstacles facing the diabetic students to achieve an accepted self-management;
4. To assess the impact of the interventional program on overcoming such obstacles; and
5. 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.

Eligibility criteria: Inclusion Criteria:

•Confirmed cases of diabetes mellitus (IDD" type I" \& NIDD "type II") among Assiut University students

Exclusion Criteria:

* 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.

Primary outcomes:
measure: assessment of change in Perceived Obstacles to diabetes self-management that faced by participants
timeFrame: at base line, three months and six months after the end of the program.
measure: assessment of Change in Diabetes Self-management
timeFrame: at base line, three months and six months after the end of the program.
measure: assessment of change in measurements of glycated hemoglobin (HbA1c)
timeFrame: at base line, three months and six months after the end of the program.
Secondary outcomes:
measure: assessment of change in measurement of body mass index (BMI)
timeFrame: at base line, three months and six months after the end of the program.
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: faculty of medicine / Assiut university
Study officials:
affiliation: Assiut University
name: Mohammad Hassan Qayed, Chair
role: STUDY_CHAIR
affiliation: Internal Medicine - Assiut faculty of Medicine
name: Manal El-Sayed EzzEl-Dine Abdel-Mooty, director
role: STUDY_DIRECTOR
affiliation: Department of Sports Health Sciences, Faculty of Physical Education
name: Emad Shaban Ali Hassan, director
role: STUDY_DIRECTOR
References: