Impact of an Interventional Program on Diabetes Self Management

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05763303
Collaborator
(none)
300
1
2
16
18.7

Study Details

Study Description

Brief Summary

The goal of this non randomized clinical trial study is to test the effect of an interventional educational program to counter act obstacles against diabetes self-management and effective glycemic control among diabetic students in Assuit university

Condition or Disease Intervention/Treatment Phase
  • Other: educational program
N/A

Detailed Description

  1. To detect obstacles against effective glycemic control in the studied group

  2. To estimate the effect of an interventional program on the detected obstacles

  3. To evaluate the influence of diabetes self-management on glycemic control among participants 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, physical activity, healthy diet and measurements of glycated hemoglobin (HbA1c), body weight, height, at base line, three months, and 6 months after the end of the program.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of an Interventional Program on Diabetes Self Management Among Diabetic Students in Assiut University
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

received interventional program which will consist of : -The educational part: will be four sessions (about one hour for each session at 1-week interval) which are delivered by researcher to group of participants (15 participants for each group) after data collection and blood analysis by simplified manner via lectures, group discussions, questions and answers, and slideshows 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
interventional program consists of educational part and training part in case of agreement of participants

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

Outcome Measures

Primary Outcome Measures

  1. assessment of change in Perceived Obstacles to diabetes self-management that faced by participants [at base line, and three months after the end of the program.]

    by short version of the diabetic obstacle questionnaire.

  2. assessment of Change in Diabetes Self-management [at base line, and three months after the end of the program.]

    by diabetes self-management questionnaire,

  3. assessment of change in measurements of glycated hemoglobin (HbA1c) [at base line, and three months after the end of the program.]

    by blood analysis to measure (HbA1c)

Secondary Outcome Measures

  1. assessment of change in measurement of body mass index (BMI) [at base line, and three 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Confirmed students with diabetes aged 18 years and older

  • Students with duration of more than twelve months of diabetes diagnosis in order to avoid the immediate period following diagnosis

  • Diabetic students who have regular visits to Study's clinics

Exclusion Criteria:
  • Students with diabetes and on medication for less than 12 months from the study

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 faculty of medicine / Assiut university Asyut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ahmed Khair, director, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramadan Ali Hamza, Physician at The Health Directorate in Asyut Governorate, Assiut University
ClinicalTrials.gov Identifier:
NCT05763303
Other Study ID Numbers:
  • Diabetes Self Management
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023