Crohn's DiseaseNCT00376649
Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes
A study testing lifestyle changing workshop in people with Crohn's Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- lifestyle changing workshop
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- diagnosed with CD
- Crohn's Disease Activity Index (CDAI) of under 170
- a minimum of 75% of the meetings
Who cannot join
- patients with a stoma
- and patients with a planned admission to the hospital for surgery or other treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment
Read the detailed description
Participants will be randomly assigned to a regular threatment (control group) or to a lifestyle changing workshop. The workshop will consist of 11 meetings with behavioral lessons in nutrition, cooking, stress realese and physical activity. The study population will include 100 crohn's disease patients in remmision that will be recruited and will be randomly divided into two groups: an intervention group of 50 will commence the workshop during 2007 and a control group of 50 who will continue their regular threatment. an IBDQ , CDAI and blood samples for metabolic index will be taken from the participant in the staudy before entering the study and every half a year for three years.
- Conditions
- Crohn's Disease
- Being tested
- lifestyle changing workshop
- Keywords
- crohns, quality of life, lifestyle changing, remmision
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle changing workshopBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startJan 2007
- Study completionDec 2009 (estimated)
Why it stopped: funding was not granted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Rifat safadi, md, Principal investigator, hadassah univercity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376649
- Sponsor's protocol ID
- 16-031106-HMO-CTIL
- Status last verified
- Sep 2006
- First submitted
- 14 Sep 2006
- Last updated
- 22 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes
- ClinicalTrials.gov ID
- NCT00376649
- Acronym / sponsor ID
- 16-031106-HMO-CTIL
- Conditions
- Crohn's Disease
- Keywords
- crohns, quality of life, lifestyle changing, remmision
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding was not granted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 15 Sep 2006 (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.
Subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment
Detailed description
Participants will be randomly assigned to a regular threatment (control group) or to a lifestyle changing workshop. The workshop will consist of 11 meetings with behavioral lessons in nutrition, cooking, stress realese and physical activity. The study population will include 100 crohn's disease patients in remmision that will be recruited and will be randomly divided into two groups: an intervention group of 50 will commence the workshop during 2007 and a control group of 50 who will continue their regular threatment. an IBDQ , CDAI and blood samples for metabolic index will be taken from the participant in the staudy before entering the study and every half a year for three years.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years of age
- diagnosed with CD
- Crohn's Disease Activity Index (CDAI) of under 170
- a minimum of 75% of the meetings
Key exclusion criteria (2 listed)
- patients with a stoma
- and patients with a planned admission to the hospital for surgery or other treatment.
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 changing workshop | Behavioural | – |
Primary outcome
Not reported in the source record.
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 22 Sep 2015.
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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.
Rifat safadi, md principal investigator
hadassah univercity hospital
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 changing workshop in people with Crohn's Disease, 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 4 inclusion and 2 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 22 Sep 2015. 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.
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 22 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.