Impact of an Interventional Program on Self-Management

NCT ID: NCT05763303

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2025-10-01

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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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.

Conditions

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Diabetes Self Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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intervention group

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,

Group Type EXPERIMENTAL

educational program

Intervention Type OTHER

interventional program consists of educational part and training part in case of agreement of participants

control group

traditional care: the participants will received traditional care in health facility but nothing by researcher

Group Type OTHER

educational program

Intervention Type OTHER

interventional program consists of educational part and training part in case of agreement of participants

Interventions

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educational program

interventional program consists of educational part and training part in case of agreement of participants

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ramadan Ali Hamza

Physician at The Health Directorate in Asyut Governorate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad Hassan Qayed, Chair

Role: STUDY_CHAIR

Assiut University

Manal El-Sayed EzzEl-Dine Abdel-Mooty, director

Role: STUDY_DIRECTOR

Internal Medicine - Assiut faculty of Medicine

Emad Shaban Ali Hassan, director

Role: STUDY_DIRECTOR

Department of Sports Health Sciences, Faculty of Physical Education

Locations

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faculty of medicine / Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ramadan Ai, Investigato

Role: CONTACT

01112586630

Medhat Araby, Chair

Role: CONTACT

01000032910

Facility Contacts

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Ramadan Ali

Role: primary

01112586630

Medhat Araby, proph

Role: backup

01000032910

Other Identifiers

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Diabetes Self Management

Identifier Type: -

Identifier Source: org_study_id

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