Impact of Cooking Workshops on Obese AdultsCuisTONCT05693506
Impacts of Remote Cooking Workshops on Patients With Obesity (CuisTO)
A study testing Cooking workshops in people with Impact of Cooking Workshops on Obese Adults, run by Centre Hospitalier FH Manhes at 6 sites in France.
Trial summary
The implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Impact of Cooking Workshops on Obese Adults
- What is being tested?
- Cooking workshops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 6 sitesFrance
- Study dates
- 6 Feb 2023to May 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult able to cook at home,
- BMI greater than or equal to 30 kg/m²,
- Being affiliated or beneficiaries of a social security scheme,
- can be followed on an outpatient basis,
- with physical and mental autonomy to cook,
- having a kitchen in their place of accommodation (home, household, etc.),
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- ability to understand French,
- agreeing to answer the various questionnaires,
- having signed the information and consent form
- Patient having the necessary tools for a workshop by videoconference (smartphone, tablet or computer)
- Patient with sufficient connectivity for a videoconference in their kitchen (wifi, 4G network etc.)
Who cannot join
- patient undergoing bariatric surgery
- patient planning to undergo bariatric surgery within 6 months
- patient who is not affiliated or beneficiary of a social security scheme,
- patient taking part in another experimental research that may interfere with his physical or mental state to cook for the duration of the study.
- patient having treatments that could have an impact on the study criteria will be excluded (treatment with cortisone, neuroleptics, etc.) according to the judgment of the doctors of the departments concerned
- patient with an unstabilized pathology (hyper or hypothyroidism, etc.) that could have an impact on the study criteria according to the judgment of the doctors in the departments concerned
- patient having attended other programs or other cooking workshops (whether therapeutic or not, "chefs' workshop" type) in the last 6 months
- patient having planned to attend other programs or other cooking workshops (whether therapeutic or not, "chefs' workshop" type) apart from those offered during the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CH Bligny
Briis-sous-Forges, 91640
Carole PILLIAS, 01 69 26 30 00, carole.pillias.diet@gmail.com
Carole PILLIAS
- Recruiting
Hôpital FORCILLES
Férolles-Attilly, 77150
Cécile SERON, 01.60.64.61.72, CSERON@cognacq-jay.fr
Cécile SERON
- Recruiting
CH Manhès
Fleury-Mérogis, 91700
Chloé NEURY, 01.69.25.67.07, chloe.neury@ch-manhes.fr
Chloé NEURY
- Recruiting
La Pitié Salpêtrière AP-HP.Sorbonne Université
Paris, 75013
Mireille SCHAFFNER, 01 42 16 19 13, mireille.schaffner@aphp.fr
Mireille SCHAFFNER
- Recruiting
HEGP
Paris, 75015
Aymie ZIMMER, aymie.zimmer@aphp.fr
01 56 09 55 79
- Recruiting
Hôpital Cognacq-Jay
Paris, 75015
Camille SUEL, 01.45.30.83.68, camille.suel@cognacq-jay.fr
Camille SUEL
About this study
Official title: "Impact of Remote Therapeutic Cooking Workshops in the Management of Adult Patients Living With Obesity on Dietary Balance: Randomized Interventional Study in Stepped Wedge Type Clusters"
The implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). The literature shows that adults participating in cooking workshops are satisfied and acquire cooking skills potentially useful for improving their health (WOLFSON, BLEICH, 2015; CARAHER, 1999). REICKS (2014, 2018) and REES (2012) point out, however, the low methodological quality of most of the studies conducted and, in fact, the effectiveness of therapeutic cooking workshops has not been formally demonstrated by rigorous randomized studies.
The Care and Prevention Research Unit (CRESP) of the Manhès Hospital Center then built a multicenter research protocol to demonstrate the impact of cooking workshops in the care of patients with obesity. The protocol involves 6 hospitals: Georges Pompidou European Hospital (HEGP) University Hospital Center (department of Prof S. CZERNICHOW), PITIE SALPETRIERE University Hospital Center (department of Prof J.M. OPPERT), Cognacq Jay Hospital Center, Forcilles Hospital Center, Bligny Hospital Center and Manhes Hospital Center .
Read more
The CuisTO protocol was selected by the PHRIP Jury of the DGOS (General Direction of the Care Offer French Ministry of Health) in 2019 as a high priority project.
The main objective of this research is to evaluate the effectiveness of remote cooking workshops in the management of obesity, through two methods of setting up therapeutic cooking workshops (so-called "classic" workshops and workshops in the form of "culinary challenges") to improve dietary balance in the context of the care of adult patients living with obesity. Dietary balance will be estimated by compliance with the recommendations of the latest National Health Nutrition Program (PNNS-4 2019-2023), "judged" by the PNNS-GS2 score, the consumption of fruits and vegetables, the frequency of cooking and a reduction in the consumption of ultra-processed dishes that have already been prepared.
This is a multicentre, open-label, controlled, comparative intervention study with sequential randomization in clusters (clusters) of the "stepped wedge" type
- Being tested
- Cooking workshops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking workshopsOther
Cooking workshop in classic form, i.e. with recipes imposed by the dietician on the participants, or cooking workshops in the form of culinary challenges, i.e. without imposed recipes but according to the creativity of the participants
| Study group | Role | What they receive |
|---|---|---|
| Control Group Arm A | No intervention | Arm A: Usual care in the investigating hospitals + questionnaires on daily eating habits, feeling of self-efficacy, etc. |
| Experimental Group Arm B | Experimental | Arm B: Usual care in the investigating hospitals + Classic cooking workshops (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy, etc. Receives: Other: Cooking workshops |
| Experimental Group C | Experimental | Arm C: Usual care in the investigating hospitals + Cooking workshops in the form of culinary challenges (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy... Receives: Other: Cooking workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily diet
the daily food balance, consumption of fruits and vegetables, the frequency of cooking and the reduction in the consumption of ultra-processed dishes already prepared.
These changes will be measured by the PNNS-GS2 score through a dietary survey and a frequency questionnaire (CHALTIEL et al, national health nutrition program
- guidelines score 2 (PNNS-GS2): development and validation of a diet quality score reflecting the 2017 French dietary guidelines, British Journal of Nutrition, 2019, 122, 331-342)
Measured: 3 months
Secondary outcomes (3)
Self-efficacy
Increase in the feeling of self-efficacy measured by the SEPOB (Self-Efficacy of the Obese Patient) Obesity-specific Feeling of Self-Efficacy questionnaire (DESCAMPS J et al., 2010) , measures the specific feeling of self-efficacy related to weight management usable in obese, overweight or normal weight subjects
Measured: 3 and 6 months
Patient goals
Achievement of the objectives set by the patient when he participates in a series of 6 cooking workshops such as "I would like to learn to cook vegetables" or "cook less fat". The patient completes a questionnaire (before-after) proposing different possible objectives that the patients would like to achieve by participating in a cooking workshop. When filling out the questionnaire, the patient will have to choose the 3 objectives (out of 12 proposed + 1 free) which seem important to him when he attends a cooking workshop. He will have to number from 1 to 3 the order of importance of his objectives and note on a scale of 1 to 10 the skills he thinks he has in this area. The result is given in terms of the percentage of patients who have reached their initial personalized objective(s) after the two stages of the intervention. The achievement of the objectives set will be considered as achieved if the mark between the two interventions has increased.
Measured: 3 months
BMI
Patient weight and height (Body Mass Index)
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start6 Feb 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Cooking Workshops on Obese AdultsStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- Stepped Wedge
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier FH Manhes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damien GALTIER, Centre Hospitalier FH Manhes
- Investigators
- Damien GALTIER, Principal investigator, Centre Hospitalier FH Manhès
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693506
- Sponsor's protocol ID
- 2021-A00214-37
- Acronym
- CuisTO
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of Remote Therapeutic Cooking Workshops in the Management of Adult Patients Living With Obesity on Dietary Balance: Randomized Interventional Study in Stepped Wedge Type Clusters"
- ClinicalTrials.gov ID
- NCT05693506
- Acronym / sponsor ID
- CuisTO / 2021-A00214-37
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Centre Hospitalier FH ManhesUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 23 Jan 2023 (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 implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). The literature shows that adults participating in cooking workshops are satisfied and acquire cooking skills potentially useful for improving their health (WOLFSON, BLEICH, 2015; CARAHER, 1999). REICKS (2014, 2018) and REES (2012) point out, however, the low methodological quality of most of the studies conducted and, in fact, the effectiveness of therapeutic cooking workshops has not been formally demonstrated by rigorous randomized studies.
The Care and Prevention Research Unit (CRESP) of the Manhès Hospital Center then built a multicenter research protocol to demonstrate the impact of cooking workshops in the care of patients with obesity. The protocol involves 6 hospitals: Georges Pompidou European Hospital (HEGP) University Hospital Center (department of Prof S. CZERNICHOW), PITIE SALPETRIERE University Hospital Center (department of Prof J.M. OPPERT), Cognacq Jay Hospital Center, Forcilles Hospital Center, Bligny Hospital Center and Manhes Hospital Center .
The CuisTO protocol was selected by the PHRIP Jury of the DGOS (General Direction of the Care Offer French Ministry of Health) in 2019 as a high priority project.
The main objective of this research is to evaluate the effectiveness of remote cooking workshops in the management of obesity, through two methods of setting up therapeutic cooking workshops (so-called "classic" workshops and workshops in the form of "culinary challenges") to improve dietary balance in the context of the care of adult patients living with obesity. Dietary balance will be estimated by compliance with the recommendations of the latest National Health Nutrition Program (PNNS-4 2019-2023), "judged" by the PNNS-GS2 score, the consumption of fruits and vegetables, the frequency of cooking and a reduction in the consumption of ultra-processed dishes that have already been prepared.
This is a multicentre, open-label, controlled, comparative intervention study with sequential randomization in clusters (clusters) of the "stepped wedge" type
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Stepped Wedge
| Arm | Type | Receives |
|---|---|---|
| Control Group Arm A | No intervention | –Arm A: Usual care in the investigating hospitals + questionnaires on daily eating habits, feeling of self-efficacy, etc. |
| Experimental Group Arm B | Experimental | Other: Cooking workshopsArm B: Usual care in the investigating hospitals + Classic cooking workshops (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy, etc. |
| Experimental Group C | Experimental | Other: Cooking workshopsArm C: Usual care in the investigating hospitals + Cooking workshops in the form of culinary challenges (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy... |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- adult able to cook at home,
- BMI greater than or equal to 30 kg/m²,
- Being affiliated or beneficiaries of a social security scheme,
- can be followed on an outpatient basis,
- with physical and mental autonomy to cook,
Key exclusion criteria (8 listed)
- patient undergoing bariatric surgery
- patient planning to undergo bariatric surgery within 6 months
- patient who is not affiliated or beneficiary of a social security scheme,
- patient taking part in another experimental research that may interfere with his physical or mental state to cook for the duration of the study.
- patient having treatments that could have an impact on the study criteria will be excluded (treatment with cortisone, neuroleptics, etc.) according to the judgment of the doctors of the departments concerned
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 |
|---|---|---|
| Cooking workshopsCooking workshop in classic form, i.e. with recipes imposed by the dietician on the participants, or cooking workshops in the form of culinary challenges, i.e. without imposed recipes but according to the creativity of the participants | Other | Experimental Group Arm B, Experimental Group C |
Primary outcome
daily diet
Time frame: 3 months
the daily food balance, consumption of fruits and vegetables, the frequency of cooking and the reduction in the consumption of ultra-processed dishes already prepared. These changes will be measured by the PNNS-GS2 score through a dietary survey and a frequency questionnaire (CHALTIEL et al, national health nutrition program - guidelines score 2 (PNNS-GS2): development and validation of a diet quality score reflecting the 2017 French dietary guidelines, British Journal of Nutrition, 2019, 122, 331-342)
3 secondary outcomes
Self-efficacy
Time frame: 3 and 6 months
Patient goals
Time frame: 3 months
BMI
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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.
Damien GALTIER principal investigator
Centre Hospitalier FH Manhès
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking workshops in people with Impact of Cooking Workshops on Obese Adults, run by Centre Hospitalier FH Manhes at 6 sites in France.
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 11 inclusion and 8 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Contact Damien GALTIER (00 33 610105577, damien.galtier@ch-manhes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily diet (time frame: 3 months). 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 4 Sep 2024.