Behavioral ChangesNCT01871324
The Efficacy of Group Therapy in Ultra-Orthodox Jewish Young Men Diagnosed With Type One Diabetes
A study testing Lifestyle counseling in people with Behavioral Changes, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Behavioral Changes
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Young Ultra-Orthodox men diagnosed with diabetes type one.
Who cannot join
- Psychiatric illness .
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Behavioral Changes
- Being tested
- Lifestyle counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
group therapy
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy will be evaluated using Diabetes Quality of Life questionnaire before and after the program.
Measured: three months
Secondary outcomes (1)
the efficacy will be evaluated using behavioral changes related to diabetes questionnaire before and after the program.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startSep 2013 (estimated)
- Primary completionSep 2015 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ChangesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ofri Mosenzon, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871324
- Sponsor's protocol ID
- 0560-12-HMO-CTIL
- Status last verified
- Mar 2018
- First submitted
- 4 Jun 2013
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Group Therapy in Ultra-Orthodox Jewish Young Men Diagnosed With Type One Diabetes
- ClinicalTrials.gov ID
- NCT01871324
- Acronym / sponsor ID
- 0560-12-HMO-CTIL
- Conditions
- Behavioral Changes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: technical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2013 (estimated)
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counseling |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young Ultra-Orthodox men diagnosed with diabetes type one.
Key exclusion criteria (1 listed)
- Psychiatric illness .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counselinggroup therapy | Behavioural | Lifestyle counseling |
Primary outcome
the efficacy will be evaluated using Diabetes Quality of Life questionnaire before and after the program.
Time frame: three months
1 secondary outcome
the efficacy will be evaluated using behavioral changes related to diabetes questionnaire before and after the program.
Time frame: three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Behavioral Changes, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy will be evaluated using Diabetes Quality of Life questionnaire before and after the program. (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.