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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00376649
First received: September 14, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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


Condition Intervention
Crohn's Disease
Behavioral: lifestyle changing workshop

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376649

Contacts
Contact: Rifat Safadi, MD 972-2-6777377 safadi@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Suspended
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Rifat safadi, md hadassah univercity hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00376649     History of Changes
Other Study ID Numbers: 16-031106-HMO-CTIL
Study First Received: September 14, 2006
Last Updated: September 14, 2006
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Hadassah Medical Organization:
crohns
quality of life
lifestyle changing
remmision

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014