NCT01871324

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

June 4, 2013

Last Update Submit

March 1, 2018

Conditions

Behavioral Changes

Outcome Measures

Primary Outcomes (1)

  • the efficacy will be evaluated using Diabetes Quality of Life questionnaire before and after the program.

    three months

Secondary Outcomes (1)

  • the efficacy will be evaluated using behavioral changes related to diabetes questionnaire before and after the program.

    three months

Other Outcomes (1)

  • the efficacy will be evaluated using HbA1c values, glucose levels before and after the program

    three months

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: Lifestyle counseling

Interventions

Lifestyle counselingBEHAVIORAL

group therapy

Lifestyle counseling

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young Ultra-Orthodox men diagnosed with diabetes type one.

You may not qualify if:

  • Psychiatric illness .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Diabetes Research Unit

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 6, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

March 1, 2019

Last Updated

March 2, 2018

Record last verified: 2018-03

Locations

IL(1)