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NCT00376649 Clinical Trial

Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes

Crohn's Disease Clinical Trial

Official title:
Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00376649
Other study ID # 16-031106-HMO-CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received September 14, 2006
Last updated September 20, 2015
Start date January 2007
Est. completion date December 2009

Study information
Verified date September 2006
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical 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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18 years of age

- diagnosed with CD

- Crohn's Disease Activity Index (CDAI) of under 170

- a minimum of 75% of the meetings

Exclusion Criteria:

- patients with a stoma

- and patients with a planned admission to the hospital for surgery or other treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Behavioral:
• lifestyle changing workshop

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

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