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NCT Number: NCT05763303

Impact of an Interventional Program on Self-Management

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • To formulate a strategy aiming to reduce the burden of diabetes morbidity & mortality;
  • To determine degree of self-management in diabetic participants
  • To identify the obstacles facing the diabetic students to achieve an accepted self-management;
  • To assess the impact of the interventional program on overcoming such obstacles; and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational program

Other

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

Primary outcomes

  1. 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.

  2. 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,

  3. 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)

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Medhat Araby, Chair

CONTACT

[email protected]

01000032910

Ramadan Ai, Investigato

CONTACT

[email protected]

01112586630

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2023
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.