Impacts of Remote Cooking Workshops on Patients With Obesity (CuisTO) (CuisTO)

February 20, 2023 updated by: Damien GALTIER, Centre Hospitalier FH Manhes

"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 .

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 Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Briis-sous-Forges, France, 91640
        • Recruiting
        • CH Bligny
        • Contact:
        • Principal Investigator:
          • Carole PILLIAS
      • Fleury-Mérogis, France, 91700
        • Recruiting
        • CH Manhès
        • Contact:
        • Principal Investigator:
          • Chloé NEURY
      • Férolles-Attilly, France, 77150
        • Recruiting
        • Hôpital Forcilles
        • Contact:
        • Principal Investigator:
          • Cécile SERON
      • Paris, France, 75015
        • Recruiting
        • HEGP
        • Contact:
        • Contact:
          • Phone Number: 01 56 09 55 79
        • Principal Investigator:
          • Aymie ZIMMER
      • Paris, France, 75013
        • Recruiting
        • La Pitié Salpêtrière AP-HP.Sorbonne Université
        • Contact:
        • Principal Investigator:
          • Mireille SCHAFFNER
      • Paris, France, 75015
        • Recruiting
        • Hôpital Cognacq-Jay
        • Contact:
        • Principal Investigator:
          • Camille SUEL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group Arm A
Arm A: Usual care in the investigating hospitals + questionnaires on daily eating habits, feeling of self-efficacy, etc.
Experimental: Experimental Group Arm B
Arm B: Usual care in the investigating hospitals + Classic cooking workshops (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy, etc.
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
Experimental: Experimental Group C
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...
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: 3 and 6 months
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
3 and 6 months
Patient goals
Time Frame: 3 months
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.
3 months
BMI
Time Frame: 3 and 6 months
Patient weight and height (Body Mass Index)
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Damien GALTIER, Centre Hospitalier FH Manhès

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-A00214-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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