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ClinicalTrials.gov ID

NCT05693506

Lead Sponsor

Centre Hospitalier FH ManhesOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

420Estimated

Last Update Posted

Sep 4, 2024Actual

Start Date

Feb 6, 2023Actual

Primary Completion Date

May 2025Estimated

Completion Date

May 2025Estimated

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"

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

• Impact of Cooking Workshops on Obese Adults

• Cooking workshops

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Prevention

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier FH ManhesOTHER

aymie.zimmer@aphp.fr