Impact of an Interventional Program on Self-Management

June 5, 2025 updated by: Ramadan Ali Hamza, Assiut University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohammad Hassan Qayed, Chair, Assiut University
  • Study Director: Manal El-Sayed EzzEl-Dine Abdel-Mooty, director, Internal Medicine - Assiut faculty of Medicine
  • Study Director: Emad Shaban Ali Hassan, director, Department of Sports Health Sciences, Faculty of Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetes Self Management

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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