Impact of an Interventional Program on Self-Management

Not Applicable

Recruiting

• Conditions: Diabetes Self Management

• Registration Number: NCT05763303
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-10
• Study Start: 2023-10-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of change in measurements of glycated hemoglobin (HbA1c)	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	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	at base line, three months and six months after the end of the program.	by short version of the diabetic obstacle questionnaire.

Secondary Outcome Measures

Name	Time	Method
assessment of change in measurement of body mass index (BMI)	at base line, three months and six months after the end of the program.	by measurement of weight in kilograms and height in meters and use formula: (BMI) = weight in kilograms ÷ ( height in meter × height in meter)

Trial Locations

Locations (1)

faculty of medicine / Assiut university; 🇪🇬 Asyut, Egypt