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

Primary Purpose

Impact of Cooking Workshops on Obese Adults

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cooking workshops
Sponsored by
Centre Hospitalier FH Manhes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impact of Cooking Workshops on Obese Adults

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH BlignyRecruiting
  • CH ManhèsRecruiting
  • Hôpital FORCILLESRecruiting
  • La Pitié Salpêtrière AP-HP.Sorbonne UniversitéRecruiting
  • HEGPRecruiting
  • Hôpital Cognacq-JayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group Arm A

Experimental Group Arm B

Experimental Group C

Arm Description

Arm A: Usual care in the investigating hospitals + questionnaires on daily eating habits, feeling of self-efficacy, etc.

Arm B: Usual care in the investigating hospitals + Classic cooking workshops (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy, etc.

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...

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.
BMI
Patient weight and height (Body Mass Index)

Full Information

First Posted
December 22, 2022
Last Updated
February 20, 2023
Sponsor
Centre Hospitalier FH Manhes
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1. Study Identification

Unique Protocol Identification Number
NCT05693506
Brief Title
Impacts of Remote Cooking Workshops on Patients With Obesity (CuisTO)
Acronym
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier FH Manhes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impact of Cooking Workshops on Obese Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped Wedge
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group Arm A
Arm Type
No Intervention
Arm Description
Arm A: Usual care in the investigating hospitals + questionnaires on daily eating habits, feeling of self-efficacy, etc.
Arm Title
Experimental Group Arm B
Arm Type
Experimental
Arm Description
Arm B: Usual care in the investigating hospitals + Classic cooking workshops (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy, etc.
Arm Title
Experimental Group C
Arm Type
Experimental
Arm Description
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...
Intervention Type
Other
Intervention Name(s)
Cooking workshops
Intervention Description
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
Primary Outcome Measure Information:
Title
daily diet
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Self-efficacy
Description
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
Time Frame
3 and 6 months
Title
Patient goals
Description
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.
Time Frame
3 months
Title
BMI
Description
Patient weight and height (Body Mass Index)
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien GALTIER
Phone
00 33 610105577
Email
damien.galtier@ch-manhes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien GALTIER
Organizational Affiliation
Centre Hospitalier FH Manhès
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Bligny
City
Briis-sous-Forges
ZIP/Postal Code
91640
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole PILLIAS
Phone
01 69 26 30 00
Email
carole.pillias.diet@gmail.com
First Name & Middle Initial & Last Name & Degree
Carole PILLIAS
Facility Name
CH Manhès
City
Fleury-Mérogis
ZIP/Postal Code
91700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloé NEURY
Phone
01.69.25.67.07
Email
chloe.neury@ch-manhes.fr
First Name & Middle Initial & Last Name & Degree
Chloé NEURY
Facility Name
Hôpital FORCILLES
City
Férolles-Attilly
ZIP/Postal Code
77150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile SERON
Phone
01.60.64.61.72
Email
CSERON@cognacq-jay.fr
First Name & Middle Initial & Last Name & Degree
Cécile SERON
Facility Name
La Pitié Salpêtrière AP-HP.Sorbonne Université
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireille SCHAFFNER
Phone
01 42 16 19 13
Email
mireille.schaffner@aphp.fr
First Name & Middle Initial & Last Name & Degree
Mireille SCHAFFNER
Facility Name
HEGP
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aymie ZIMMER
Email
aymie.zimmer@aphp.fr
Phone
01 56 09 55 79
First Name & Middle Initial & Last Name & Degree
Aymie ZIMMER
Facility Name
Hôpital Cognacq-Jay
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille SUEL
Phone
01.45.30.83.68
Email
camille.suel@cognacq-jay.fr
First Name & Middle Initial & Last Name & Degree
Camille SUEL

12. IPD Sharing Statement

Plan to Share IPD
No

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

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