MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Michael Method

• Registration Number: NCT01691287
• Lead Sponsor: Rabin Medical Center

Brief Summary

Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as well.

Compliance to treatment is a major challenge for all patients and mostly to adolescence, which often worsen their diabetes control at that age.

The Michael Method is a unique, holistic program to develop and realize an individual's emotional, intellectual and behavioral potential, which is based on the belief that every human being can excel in every field they choose. The method was developed in 1988 by a multi-disciplinary team of professional academic in Israel. Today the Israeli education system implements the method in Junior High Schools and High Schools in diverse educational sectors. The program is taught at many other various frameworks: teachers' continuing education programs, colleges, programs run by the Ministries of Defense and Social Welfare, the National Insurance Institute, the National Electric Corporation and in many other public and private frameworks.

The proposed study is aimed to assess whether the Michael Method can be used as a tool for improving metabolic control and quality of life among uncontrolled adolescence with type 1 diabetes

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-24
• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Type 1 Diabetes at least 1 year prior to study inclusion
• 12-17 years old
• HbA1c > 7.8%

Exclusion Criteria

• Incapability to comply with all study requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Michael Method	Michael Method	14 group meeting, taking place once a week during 14 consecutive weeks

Primary Outcome Measures

Name	Time	Method
Metabolic Control measured as HbA1c level	at the end of the study - after 15 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Diabetic Keto Acidosis events	at the end of the study- after 15 weeks
Diabetes Quality of Life questionnaire (DQOLY)	At the end of the study- after 15 weeks
Self assessment questionnaire	At the end of the study- after 15 weeks
Number of severe hypoglycemic events	at the end of the study-after 15 weeks

Trial Locations

Locations (1)

Schneider Medical Center; 🇮🇱 Petah-TTikva, Israel