- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00364338
Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women
September 20, 2015 updated by: Hadassah Medical Organization
Subjects that participate in the practical workshop will improve their metabolic indexes, decrease their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop.
The workshop will consist of 9 lessons with the following lessons: introduction, fats, phytoestrogens, carbohydrates and fibers, calcium and low calorie diet, party's recipes, shopping and farewell dinner.
All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef.
The study population will include healthy women attending the menopause clinic.
72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only.
During 2008 the control group will commence the workshop and will add to the study group.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jerusalem, Israel
- Hadassah Medical Organization
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age of 45-60
- Perimenopause
- Healthy
- BMI over 17
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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We expect to see change in the following outcomes:
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the patient's metabolic state,
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the patient's weight
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body composite
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patient's quality of life.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ronit kochman, md, Hadassah University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
August 14, 2006
First Submitted That Met QC Criteria
August 14, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Estimate)
September 22, 2015
Last Update Submitted That Met QC Criteria
September 20, 2015
Last Verified
August 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- 30-150906-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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