NCT05693506

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

December 22, 2022

Last Update Submit

August 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 months

Secondary Outcomes (3)

  • Self-efficacy

    3 and 6 months

  • Patient goals

    3 months

  • BMI

    3 and 6 months

Study Arms (3)

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.

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...

Other: Cooking workshops

Interventions

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 Group Arm BExperimental Group C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH Bligny

Briis-sous-Forges, 91640, France

RECRUITING

Hôpital FORCILLES

Férolles-Attilly, 77150, France

RECRUITING

CH Manhès

Fleury-Mérogis, 91700, France

RECRUITING

La Pitié Salpêtrière AP-HP.Sorbonne Université

Paris, 75013, France

RECRUITING

HEGP

Paris, 75015, France

RECRUITING

Hôpital Cognacq-Jay

Paris, 75015, France

RECRUITING

Study Officials

  • Damien GALTIER

    Centre Hospitalier FH Manhès

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped Wedge
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
care and prevention research coordinator

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 23, 2023

Study Start

February 6, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

September 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations