Impact of an Interventional Program on Self-Management

NCT05763303 | Recruiting

• 1 other identifier: Diabetes Self Management
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Self Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• assessment of change in measurement of body mass index (BMI)

  at base line, three months and six months after the end of the program.

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

OTHER

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

Other: educational program

Interventions

educational program OTHER

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

control group; intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed cases of diabetes mellitus (IDD" type I" \& NIDD "type II") among Assiut University students

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

faculty of medicine / Assiut university

Asyut, Egypt

RECRUITING

Study Officials

• Mohammad Hassan Qayed, Chair

  Assiut University

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Ramadan Ai, Investigato

CONTACT

01112586630; alidrrmadan@yahoo.com

Medhat Araby, Chair

CONTACT

01000032910; Medhatelaraby75@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician at The Health Directorate in Asyut Governorate

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 10, 2023
• Study Start: October 25, 2023
• Primary Completion: September 15, 2025
• Study Completion: October 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)