- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01871324
The Efficacy of Group Therapy in Ultra-Orthodox Jewish Young Men Diagnosed With Type One Diabetes
March 1, 2018 updated by: Ofri Mosenzon, Hadassah Medical Organization
The purpose of this study is to compare the influence of an intervention program especially designed to young ultra orthodox men that were diagnosed with diabetes type one.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
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 Locations
-
-
-
Jerusalem, Israel
- Hadassah Medical Organization, Jerusalem, Israel
-
-
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 to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Young Ultra-Orthodox men diagnosed with diabetes type one.
Exclusion Criteria:
- Psychiatric illness .
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle counseling
|
group therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the efficacy will be evaluated using Diabetes Quality of Life questionnaire before and after the program.
Time Frame: three months
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the efficacy will be evaluated using behavioral changes related to diabetes questionnaire before and after the program.
Time Frame: three months
|
three months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the efficacy will be evaluated using HbA1c values, glucose levels before and after the program
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
September 1, 2013
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
June 4, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 6, 2013
Study Record Updates
Last Update Posted (Actual)
March 2, 2018
Last Update Submitted That Met QC Criteria
March 1, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 0560-12-HMO-CTIL
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.