Clinical trial NCT05693506: Impacts of Remote Cooking Workshops on Patients With Obesity (CuisTO)
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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impact of Cooking Workshops on Obese Adults
Lead sponsor: Centre Hospitalier FH Manhes
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge
Primary purpose: PREVENTION

Brief 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). 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


Eligibility criteria: Inclusion Criteria:

* 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.),
* 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.)

Exclusion Criteria:

* 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

Primary outcomes:
measure: daily diet
timeFrame: 3 months
Secondary outcomes:
measure: Self-efficacy
timeFrame: 3 and 6 months
measure: Patient goals
timeFrame: 3 months
measure: BMI
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Briis-sous-Forges
country: France
facility: CH Bligny
city: Fleury-Mérogis
country: France
facility: CH Manhès
city: Férolles-Attilly
country: France
facility: Hôpital FORCILLES
city: Paris
country: France
facility: La Pitié Salpêtrière AP-HP.Sorbonne Université
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital Cognacq-Jay
Study officials:
affiliation: Centre Hospitalier FH Manhès
name: Damien GALTIER
role: PRINCIPAL_INVESTIGATOR
References: