Eating DisordersNCT04538846
Culinary Art Therapy Group for Adults With Eating Disorders.
A study testing Culinary art therapy in people with Eating Disorders and Behavior, Eating, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders. It will assess changes in thinking patterns and behavioural patterns associated with food and eating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Behavior, Eating, Relationship, Family
- What is being tested?
- Culinary art therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Nov 2020to Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of eating disorder
- Body Mass Index (BMI) > 15
Who cannot join
- No active participation in three group sessions
- Refusal to take an active part in the sessions
Trial locations and contacts
1 site in 1 country.
Israel1 site
Eating disorders outpatients department, Hadassah Medical Center
Jerusalem
About this study
Official title: Culinary Art Therapy Group for Adults With Eating Disorders: Assessment of Influence on Thinking, Patterns and Behaviour Related to Food.
The study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders. It will assess changes in thinking patterns and behavioural patterns associated with food and eating.
- Being tested
- Culinary art therapy
- Medical subject headings
- Feeding and Eating Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary art therapyOther
Culinary art therapy is a novel approach which broadly perceives food and cooking as enabling participants to explore needs, patterns and relationships and facilitate therapeutic processes.
| Study group | Role | What they receive |
|---|---|---|
| Culinary Art Therapy Group | Experimental | Patients with eating disorders that will participate in a weekly session of culinary art therapy group. Receives: Other: Culinary art therapy |
| No Culinary Art Therapy Intervention | No intervention | Patients with eating disorders that are not scheduled to come to the outpatients ward on the day of intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Attitudes Test (EAT-26)
This is a screening measure to help determine whether a person might have an eating disorder that needs professional attention. This screening measure is not designed to make a diagnosis of an eating disorder or take the place of a professional consultation.
Measured: 3 months
Eating & Meal Preparation Skills Questionnaire (EMPSA)
The EMPSA is a 12-item self-report assessment tool designed to measure eating disordered clients' perceived ability and motivation to perform 12 eating and meal preparation tasks.
Measured: 3 months
Rosenberg Self-Esteem Scale (RSES)
The Rosenberg Self-Esteem Scale (RSES) assesses global self-esteem and sense of self-worthiness.
Measured: 3 months
Secondary outcomes (2)
Assessment of Communication and Interaction Skills (ACIS)
The ACIS is an observational assessment that gathers data on communication and interaction skills. Three domains, physicality, information exchange, and relations, are used to describe different aspects of communication and interaction. The ACIS gathers data on skill as it is exhibited during performance in an occupational form and/or within a social group.
Measured: 3 months
Individual semi-structured interview
Interviews aimed to allow each participant to relate to his or her own experience in a more independent and possibly safer setting.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start11 Nov 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Quasi-Experimental Study
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, Adi Schleyer, Hadassah Medical Organization
- Investigators
- Adi Stern, Dr., Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538846
- Sponsor's protocol ID
- 0482-20-HMO
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culinary Art Therapy Group for Adults With Eating Disorders: Assessment of Influence on Thinking, Patterns and Behaviour Related to Food.
- ClinicalTrials.gov ID
- NCT04538846
- Acronym / sponsor ID
- 0482-20-HMO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 4 Sep 2020 (actual)
- 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.
The study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders. It will assess changes in thinking patterns and behavioural patterns associated with food and eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-Experimental Study
| Arm | Type | Receives |
|---|---|---|
| Culinary Art Therapy Group | Experimental | Other: Culinary art therapyPatients with eating disorders that will participate in a weekly session of culinary art therapy group. |
| No Culinary Art Therapy Intervention | No intervention | –Patients with eating disorders that are not scheduled to come to the outpatients ward on the day of intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of eating disorder
- Body Mass Index (BMI) > 15
Key exclusion criteria (2 listed)
- No active participation in three group sessions
- Refusal to take an active part in the sessions
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 |
|---|---|---|
| Culinary art therapyCulinary art therapy is a novel approach which broadly perceives food and cooking as enabling participants to explore needs, patterns and relationships and facilitate therapeutic processes. | Other | Culinary Art Therapy Group |
Primary outcome
Eating Attitudes Test (EAT-26)
Time frame: 3 months
This is a screening measure to help determine whether a person might have an eating disorder that needs professional attention. This screening measure is not designed to make a diagnosis of an eating disorder or take the place of a professional consultation.
Eating & Meal Preparation Skills Questionnaire (EMPSA)
Time frame: 3 months
The EMPSA is a 12-item self-report assessment tool designed to measure eating disordered clients' perceived ability and motivation to perform 12 eating and meal preparation tasks.
Rosenberg Self-Esteem Scale (RSES)
Time frame: 3 months
The Rosenberg Self-Esteem Scale (RSES) assesses global self-esteem and sense of self-worthiness.
2 secondary outcomes
Assessment of Communication and Interaction Skills (ACIS)
Time frame: 3 months
Individual semi-structured interview
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Adi Stern, Dr. principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culinary art therapy in people with Eating Disorders and Behavior, Eating, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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?
Results are not available in the source record.
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?
Eating Attitudes Test (EAT-26) (time frame: 3 months). The study lists 3 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 23 Feb 2021.