Impact of an Interventional Program on Self-Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of an Interventional Program on Self-Management Among Students With Diabetes in Assiut University

Conditions
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Diabetes Self Management

Intervention / Treatment
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* Other: educational program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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, | Other: educational program<br>* interventional program consists of educational part and training part in case of agreement of participants<br>|
| Other: control group<br>traditional care: the participants will received traditional care in health facility but nothing by researcher | Other: educational program<br>* interventional program consists of educational part and training part in case of agreement of participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of change in Perceived Obstacles to diabetes self-management that faced by participants | by short version of the diabetic obstacle questionnaire. | 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, | 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) | at base line, three months and six months after the end of the program. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | at base line, three months and six months after the end of the program. |