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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00364975
Other study ID # 31150906-HMO-CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received August 15, 2006
Last updated September 20, 2015
Start date December 2006
Est. completion date December 2007

Study information

Verified date August 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 metabolic indexes, control their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions


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 6 lessons with the following lessons: introduction, caloric density of food, fats, vegetable and fruits, Whole grains and legumes, Healthy desserts . 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 women receiving adjuvant chemotherapy for breast cancer. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Adjuvant chemotherapy

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
gourmet cooking 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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary: We expect to see change in the following outcomes: the patient's metabolic state, the patient's weight, body composite, patient's quality of life.
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