"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"
Phase: NA
Conditions: Impact of Cooking Workshops on Obese Adults
Sponsor: 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 clusters" 
 
 
Therapeutic Kitchen of Obese Patient Project 
(CuisTO) 
RCB ID No.: 2021-A00214-37 
 
 
Version n°2 of the CuisTO protocol : 20/10/2022 
 
Coordinating Investigator : Damien GALTIER 
 
 
 
 
Cellule de Recherche en Soin Paramédical et Prévention 
 
 
 
 
CH Frédéric Henry Manhès (91) 
00331 69 25 64 61 / damien.galtier@ch-manhes.fr 
 
Promoter : 
 
 
Centre Hospitalier FH Manhès 
 
 
 
 
8 rue Roger Clavier 
91700 Fleury-Mérogis 
00331 69 25 64 00 
 
 
 
 
 
 

1 
 
Table of Contents 
 
SYNOPSIS............................................................................................................................................ 2 
BACKGROUND................................................................................................................................... 4 
MODIFICATION OF THE CUISTO PROTOCOL RELATED TO THE COVID-19 CRISIS ........... 4 
DIFFERENCES FROM USUAL CARE ............................................................................................. 5 
HYPOTHESIS……………………………………………………………………….......................... 5 
MAIN OBJECTIVE ............................................................................................................................. 6 
SECONDARY OBJECTIVES ............................................................................................................. 6 
PRIMARY ENDPOINT ....................................................................................................................... 6 
SECONDARY EVALUATION CRITERIA........................................................................................ 7 
INCLUSION CRITERIA ......................................................................................................................7 
NON-INCLUSION CRITERIA ........................................................................................................... 8 
EXPECTED BENEFITS ...................................................................................................................... 8 
EVALUATION OF THE BENEFITS AND RISKS ASSOCIATED WITH RESEARCH................. 9 
SEARCH CHARACTERISTICS ............................................................................................................ 9 
STATISTICAL ANALYSES…………………………………………………………………............ 9 
SOURCES OF FUNDING.................................................................................................................. 11 
PROVISIONAL TIMETABLE .......................................................................................................... 11 
BIBLIOGRAPHICAL REFERENCES .............................................................................................. 11 
 
 

2 
 
 
 
 
PROMOTER 
Centre Hospitalier Frédéric Henry 
Manhès 8 rue Roger Clavier 
91300 Fleury-Mérogis 
TITLE 
« Impact of remote therapeutic cooking workshops in the management 
of adult patients living with obesity on dietary balance : 
Stepped Wedge cluster-randomized interventional study » 
ACRONYM 
" CuisTO Project " (Cuisine Therapeutic of patient Obèse) 
Version 
Version of Protocol n°2 of 09/08/21 
PRINCIPAL 
INVESTIGATOR 
Damien GALTIER 
Dietician, Paramedical Coordinator of Care Research 
C.R.E.P.S. of CH Manhès, Fleury-Mérogis 
damien.galtier@ch-manhes.fr or 
dam.galtier@gmail.com 
PROFESSION- 
ASSOCIATED 
AND/OR 
CONCERNED 
STEERING COMMITTEE (SPC) 
 
Pr Etienne AUDUREAU, methodologist, biostatistician, Henri Mondor, Créteil, President 
of the CP "CuisTO " (94) 
Damien GALTIER, Dietician, Paramedical Coordinator of Care Research , CH Manhès 
(91) 
Nicolas DARCEL, Associate Professor , PNCA Research Unit , Agro Paris Tech (75) 
Camille HARPON, Assistant of Clinical Research , Lyon (69) 
Thomas BOZZO, Consultant for the implementation of the CuisTO protocol , TB 
Consulting (Paris, 75) 
 
SCIENTIFIC AND SUPERVISORY BOARD (CSS) 
 
Dr Claire CARETTE, HEGP Paris, President of CSS "CuisTO" 
Pr Sébastien CZERNICHOW, HEGP Paris 
Pr Jean Michel OPPERT, CHU Pitié Salpêtrière 
Dr Jocelyne RAISON, CH Manhès and Réseau de santé 
ROMDES Dr Léa LUCAS MARTINI, CH Cognacq-Jay 
Pr Etienne AUDUREAU, Henri Mondor, Créteil,  
Nicolas DARCEL, PNCA Research Unit , AgroParisTech 
SYNOPSIS 

3 
 
 
REFERENTS INVESTIGATOR CENTERS (RCI) 
 
Camille SUEL, Dietician, Cognacq-Jay 
Cécile SERON, Dietician CH Forcilles 
Mireille SCHAFFNER, Dietician, CHU Pitié Salpêtrière 
Aymie ZIMER, Dietician HEGP 
Carole PILLIAS, CH Bligny 
Chloé NEURY, Nutritionist, CH Manhès 
 
NUMBER OF 
CENTRES 
6 
(CHU Pitié Salpêtrière ; Georges Pompidou European Hospital ; CH 
Forcilles ; CH Bligny; CH Cognacq-Jay; CH Manhès) 
TYPE OF STUDY 
Open-label , multicenter randomized controlled intervention study in
Stepped Wedge clusters » 
CHARACTER-
TIQUE 
RESEARCH 
This is a multicenter, open-label, controlled intervention study with step-wedge 
sequential randomization. This is a research in paramedical care that has received 
PHRIP funding (Hospital Nursing and Paramedical Research Program) from
the DGOS French Ministry of Health (Care Delivery Branch )  
NUMBER OF 
PARTICIPANTS 
420 patients (i.e. 4.6 patients / center / month) 
 140 in the control group : Usual management + Questionnaires (arm A) 
 280 in the interventional group: Usual care + Questionnaires + 6 cooking 
workshops: 
- either in "classic " form (arm B) 
- either in the form of "culinary challenge " (arm C) 
DURATION OF 
THE STUDY 
21 months of experimentation from the 1st inclusion 
 
 

4 
 
 
 
 
The France does not escape the "epidemic" of obesity, as demonstrated by the latest results of the 
Constances cohort (BEH Matta J et al. 2016)(1): more than 33% of French adults are overweight, and more 
than 15%, or almost 7 million people, are obese. Because of cardio-metabolic, psychological and joint 
morbidity and associated mortality, obesity is responsible for major health and economic consequences. Its 
management requires the implementation of long-term lifestyle changes, placing therapeutic patient 
education (TPE) at the heart of care (Ziegler O, 2014)(2). The High Authority for Health (HAS) 
recommends a global approach along four distinct axes (HAS, 2011)(3) : 
 Tips to promote physical activity  
 A psychological approach  
 medical follow-up  
 dietary education  
 
For the latter, 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 C, 2008)(4)(5). The literature shows that adults 
participating in cooking workshops are satisfied and acquire cooking skills that are potentially useful for 
improving their health (Wolfson JA, Bleich SN, 2015; Caraher M, 1999)(6)(7). However, Reicks (2014, 
2018)(8)(9) and Rees (2012)(10) point out 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 global COVID-19 pandemic has led to the unprecedented implementation of health measures in France 
(confinements, barrier gestures, social distancing, etc.) which initially led to the suspension of all collective 
therapeutic workshops on the hospital sites provided for in the protocol CuisTO. Initially planned as a 
research protocol on the impact of face-to-face cooking workshops when submitted and accepted by the 
Hospital Research Program in Nursing and Paramedical Care (PHRIP) of the DGOS (Ministry of Health) at 
the end of December 2019, the reflections related to the health crisis we are experiencing led us to 
reconsider our mode of operation concerning the cooking workshops. 
Context 
Modification of the CuisTO protocol linked to the covid-19 

5 
 
Thus, the members of the scientific committee of the CuisTO protocol unanimously advise that CuisTO 
adapt to this health crisis by proposing not to measure the impact of face-to-face cooking workshops, but 
the impact of remote cooking workshops. 
This suggestion would be in line with current recommendations, thus allowing the continuation of the care 
of patients, without risk to their health, and to begin our research as soon as possible. 
Our funding partners (DGOS and ARS Ile de France) have given their agreement, as long as the entire 
protocol remains unchanged in its general form : 6 centers, same objectives (measurement of the impact on 
dietary balance and psycho-social behaviors), same judgment criteria (repercussions on the main 
recommendations of the PNNS-4) and same overall budget. Only an orientation of the budget lines can be 
envisaged. 
 
 
 
 
Even if the usefulness of cooking workshops is well perceived by the medical profession (M Roussel, 
Picot, 2008)(11)), they are not sufficiently implemented in the hospital management of patients living with 
obesity. 
We also lack solid data regarding the effectiveness and value of therapeutic cooking workshops in the 
management of patients with one (or more) chronic disease(s). The only recommendations relating to the 
establishment of cooking workshops concern the regulation of hygiene standards (CCLIN-Ouest, 2002; 
DGAL 2011)(12)(13). Paradoxically, there are no recommendations for the facilitation of these workshops 
and the orientation of patients. 
Our research must therefore not only establish the importance of cooking workshops , but also give the 
desire to the various hospitals, care structures or health networks to implement them, while proposing 
useful recommendations for their practice, particularly on animation. Pedagogical (" classic" or " 
challenge"), on the possibilities of distance learning (video) and patient orientation. 
 
 
 
 
We hypothesize that the implementation of cooking workshops by video in the care of adult patients living 
with obesity allows the improvement of their dietary balance, particularly with regard to compliance with 
the recommendations of the PNNS (National Nutrition and Health Program), the consumption of fruits and 
vegetables, the frequency of cooking and the decrease in the consumption of already prepared dishes 
DIFFERENCES COMPARED TO USUAL MANAGEMENT 
HYPOTHESIS 

6 
 
 
 
 
The main objective of this research is to evaluate the effectiveness of distance cooking workshops in the 
management of obesity, through two modalities of setting up therapeutic cooking workshops, for the 
improvement of dietary balance in the context of the management of adult patients living with obesity. The 
balanced diet will be estimated by compliance with the recommendations of the last National Health 
Nutrition Program (PNNS-4 2019-2023)(14), "judged" by the PNNS-GS2 score(15), the consumption of 
fruits and vegetables, the frequency of cooking and the decrease in the consumption of dishes already 
prepared ultra-processed 
 
 
 
 Evaluate the impact of cooking workshops on dietary balance at 6 months after the start of the 
intervention (i.e. 3 months after its cessation) 
 To assess the impact of cooking workshops on weight and BMI at 3 and 6 months after the start of 
the intervention 
 Identify individual predictors of the effectiveness of cooking workshops with the implementation 
of the prioritization of patients' personal goals 
 To assess the impact of cooking workshops on the patient's sense of self-efficacy (16, given their 
involvement in obesity management (17), for improving nutrition and maintaining or losing weight 
(18), and on feelings of loneliness. 
 Evaluate among dietician facilitators the impact inherent in the "challenge" pedagogical approach 
and remote animation, through satisfaction, perceived advantages and obstacles, changes in 
practices outside obesity (ad hoc questionnaires with free comments, semi-structured interviews) 
 
 
 
 
The primary endpoint will be the absolute change at 3 months (M3) of the PNNS-GS2 score (15), 
allowing to understand in a global way the patient's adherence to the consumption benchmarks of the 
National Nutrition Health Program (PNNS) (14). 
 
 
PRIMARY OBJECTIVE 
SECONDARY OBJECTIVES 
Primary Endpoint 

7 
 
 
 
 The dietary survey and the calculation of the PNNS-GS2 again measured but at M6 (6 months after 
the start of the intervention, i.e. 3 months after its discontinuation) 
 The calculation of BMI (in m2/kg) measured at M0, M3 and M6 
 The Feeling of Self-Efficacy measured by the SEPOB (Feeling of Self-Efficacy questionnaire 
specific to Obesity) makes it possible to measure the feeling of specific personal effectiveness 
related to the management of usable weight in obese, overweight or normo-weight subjects (16) 
 The changes inherent in the "challenge" pedagogical approach as well as the remote animation will 
be evaluated through a semi-structured qualitative interview of the dieticians animating the cooking 
workshops. This measure is justified by the innovative nature of the "challenge" workshop and the 
distance learning 
 Demographic data will be collected at M0 in order to identify possible predictive factors of the 
effectiveness of cooking workshops, including gender, age, CSP (socio-professional categories), 
background, food allergies, family situation, geographical location, experience in a cooking class / 
via a menu application, EPICES score (Evaluation score of precariousness and health inequalities in 
Examination and Health Centers 
 
 
 
 Patients with all of the following criteria may be included : 
 adult with the ability 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, 
 with a kitchen in his place of accommodation (home, home ...), 
 able to understand French, 
 agreeing to answer the various questionnaires, 
 having signed the information and consent form  
 Patient with the necessary tools for a videoconference workshop (Smartphone, tablet or 
computer) 
 Patient with sufficient connectivity to a videoconference in his kitchen (wifi, 4G ...) 
 
Secondary endpoints 
INCLUSION CRITERIA 

8 
 
 
 
Patients will not be included in the study if they meet any of the following criteria : 
 bariatric surgery patient  
 patient planning to have bariatric surgery within 6 months 
 a patient who is not affiliated with or a beneficiary of a social security scheme , 
 Patient participating in other experimental research which may interfere with his physical or mental 
state to cook during the study. 
 Patients with treatments that may impact the study criteria will be excluded (treatment with 
cortisone, neuroleptic ...) according to the judgment of the doctors of the services concerned 
 patient with an unstabilized pathology (hyper or hypothyroidism ...) that may impact on the 
study criteria according to the judgment of the doctors of the departments concerned 
 patient who has attended other cooking programs or workshops (whether therapeutic or not, 
such as "chefs' workshop") in the past 6 months 
 patient who has planned to attend other programs or cooking workshops (whether therapeutic or 
not, such as "chefs' workshop") outside of those offered during the study 
 
 
 
For the patient: 
 feel useful and active in its care , 
 gain autonomy to cook, 
 improve self-esteem , 
 become aware of the importance of cooking, 
 erase the constraints of daily life that lead to not cooking thanks to the "culinary challenge" 
workshop which is close to reality (in terms of time, dealing with everyday foods, etc.), 
 losing weight, 
 get closer to the recommendations of the National Health Nutrition Program (PNNS 2019-2023) in 
terms of balanced diet, 
 fight against social isolation through group and playful workshops 
 
For public health and healthcare professionals: 
 Complete the care offer for the obese patient 
NON-INCLUSION CRITERIA 
EXPECTED BENEFITS 

9 
 
 Provide healthcare professionals with a new pedagogical approach to lead a therapeutic patient 
education workshop 
 Reduce hospitalizations and public health costs by improving the health of individuals through better 
nutrition 
 Encourage other hospitals to include cooking workshops in their treatment of obese patients 
 Allow better orientation of patients towards this or that type of cooking workshop animation 
according to their characteristics 
 Check the impact of remote workshops 
 
 
 
The care includes the filling out of various questionnaires but no particular medical examinations. 
 
 
 
This is a multicenter, open, controlled, comparative intervention study with sequential cluster randomization 
(clusters) of the "stepped wedge" type (19)(20). The chosen experimental scheme is based on an innovative 
and pragmatic approach which will make it possible to evaluate the effectiveness of the two forms of dietary 
workshops compared to the usual approach. The intervention study proposed is a multicentre randomized 
comparative study in a cluster of the “stepped wedge” type. All the centers included will be evaluated during 
a "pre-interventional" period lasting from 3 months to 9 months corresponding to the management of 
patients living with obesity without a cooking workshop, then a post-intervention period. intervention of 6 to 
12 months corresponding to the management of patients living with obesity with cooking workshops 
(whether in "classic" or "challenge" form). In total, 6 centers in Ile-de-France are invited to participate 
(Figure 1). 
This is research in paramedical care that has received PHRIP (Hospital Program for Nursing and 
Paramedical Research) funding from the DGOS (General Directorate for Healthcare) of the French Ministry 
of Health 
 
 
 
The analysis of the primary endpoint will be performed on an intention-to-treat basis and will compare the 
pre-intervention and intervention periods for all centers. The analysis of stepped wedge cluster trials 
presents a number of difficulties related in particular to the intra-cluster correlation, the one that exists 
ASSESSMENT OF RESEARCH BENEFITS AND RISKS 
Research Features 
Statistical analyzes 

10 
 
between data repeated over time, and the ability to control underlying temporal trends (21). Consequently, 
the analysis of the main judgment criterion and of the secondary quantitative criteria of the same nature 
(anthropomorphic data in particular) will be based on linear regression models with mixed effects, in order 
to introduce a random factor into the model taking into account the center level, a time term to evaluate the 
underlying evolution during the study period and an interaction term between time and treatment in order to 
identify a possible learning curve. The study will be sized to enable the main analysis to test the 
effectiveness of each intervention (challenge/classic workshop) with respect to the control periods at the 
bilateral alpha risk of 5%; in the event of significance of the two tests, a formal comparison will be carried 
out between the two interventions at the 5% risk following a hierarchical procedure in a pre-specified fixed 
sequence. Additional multivariate models will be carried out in order to take into account possible 
confounding factors and their evolution over time. 
The analysis of secondary criteria of a binary nature will be based on mixed-effects logistic regression 
models, following modeling principles identical to the description for the primary criterion. 
All analyzes will be carried out using Stata v15.1 software (StataCorp, College Station, TX, USA), within 
the Public Health Department of Henri Mondor Hospital and under the responsibility of Pr Etienne 
Audureau. 
Figure 1. Experimental design of the CuisTO study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

11 
 
 
 
 
The source of funding for the CuisTO protocol comes from two institutions: 
 The French Ministry of Health, Directorate General for the Care Offer (DGOS) thanks to the 
obtaining of the Hospital Nursing and Paramedical Research Program, letter of intent accepted in 
June 2019, file and financing accepted during the appearance before the jury in December 2019 
 The Ile de France Regional Health Agency (ARS IdF) in the additional financial contribution for 
coordination assistance 
 
 
 
 duration of the research from the 1st inclusion (February 2023) : 21 months 
 duration of participation for 1 patient : 6 months 
 main forecast dates : 
- 1st Control Group inclusion in the 6 centers: February 2023 
- 1st Intervention Group inclusion in 2 centers (out of 6): May 2023 
- Last Control Group inclusion in 2 centers (out of 6): November 2023 
- Last inclusion Groupe Intervention in the 6 centers: May 2024 
- End of experimental study: November 2024 
- End of statistical analysis: January 2025 
- Publication and communication: from February 2025 
 
 
 
 
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Provisional timetable 
Bibliographic references 

12 
 
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