PerimenopausalNCT00364338
Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women
A study testing gourment cooking workshop in people with Perimenopausal, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal
- What is being tested?
- gourment cooking workshop
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Dec 2008
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 45-60
- Perimenopause
- Healthy
- BMI over 17
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Perimenopausal
- Being tested
- gourment cooking workshop
- Keywords
- gourmet healthy cooking, quality of life, preimenopause, weight, lipids
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gourment cooking workshopBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopausalStudies 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
- Primary purpose
- Prevention
- 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
- ronit kochman, md, Principal investigator, hadassah university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364338
- Sponsor's protocol ID
- 30-150906-HMO-CTIL
- Status last verified
- Aug 2006
- First submitted
- 14 Aug 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 Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women
- ClinicalTrials.gov ID
- NCT00364338
- Acronym / sponsor ID
- 30-150906-HMO-CTIL
- Conditions
- Perimenopausal
- Keywords
- gourmet healthy cooking, quality of life, preimenopause, weight, lipids
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 15 Aug 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 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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age of 45-60
- Perimenopause
- Healthy
- BMI over 17
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gourment cooking workshop | Behavioural | – |
Primary outcome
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.
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.
ronit kochman, md principal investigator
hadassah university 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 gourment cooking workshop in people with Perimenopausal, 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 0 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.
What does the primary outcome measure?
We expect to see change in the following outcomes:. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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.