Impact of an Interventional Program on Self-Management Among Students With Diabetes in Assiut University
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Assiut University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- assessment of change in measurements of glycated hemoglobin (HbA1c)
Study Overview
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
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
intervention group
received interventional program which will consist of :
- -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.
- 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,
Intervention: educational program (Other)
control group
traditional care: the participants will received traditional care in health facility but nothing by researcher
Intervention: educational program (Other)
Outcomes
Primary Outcomes
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)
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 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.
Secondary Outcomes
- assessment of change in measurement of body mass index (BMI)(at base line, three months and six months after the end of the program.)
Investigators
Ramadan Ali Hamza
Physician at The Health Directorate in Asyut Governorate
Assiut University