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ContextAt least 40% of cancers are linked to environmental or behavioral factors, and dietary behavior appears to be a major lever. Epidaure Market is a prevention initiative developed using a method for co-constructing health promotion initiatives and prevention programs that stratifies evidence from the scientific literature and combines it with experiential knowledge (DEVA, TPB, BCT). It promotes a sustainable diet (i.e., healthy, ecological and ethical nutrition) among 5th and 4th grade students during the crucial period of adolescence, when these behaviors are often far from the recommendations.MethodThe protocol implemented was carried out in 72 middle school classes in the Montpellier and Dijon academies. The intervention included teaching sessions and a virtual supermarket game, integrated into the school curriculum and delivered by science teachers. Effectiveness is tested in a cluster randomized controlled trial with 3 evaluation times (pre- and post-intervention and 1 follow-up). The study also includes an implementation assessment, with process analysis and implementation elements, as well as a transferability assessment based on key functions (FIC model and Astaire grid).Expected outcomesThe study is still underway within the school. The primary expected outcome is a positive influence on the motives underlying food choices to move towards a sustainable diet. Secondary expectations involve changes in variables such as self-efficacy and perceived social norms, as well as an increase in knowledge about healthy eating. We also expect the qualitative approaches to provide information on the deployment process in the new territories.DiscussionThe study aims not only to demonstrate the effectiveness of Epidaure Market, but also to identify the optimal conditions for its nationwide implementation in France's middle schools. Ultimately, the initiative aims to help reduce the incidence of cancer by promoting healthier eating habits among teenagers.

Abstract Background Diet and physical activity are key components of healthy aging. Current interventions that promote healthy eating and physical activity among the elderly have limitations and evidence of French interventions’ effectiveness is lacking. We aim to assess (i) the effectiveness of a combined diet/physical activity intervention (the “ALAPAGE” program) on older peoples’ eating behaviors, physical activity and fitness levels, quality of life, and feelings of loneliness; (ii) the intervention’s process and (iii) its cost effectiveness. Methods We performed a pragmatic cluster randomized controlled trial with two parallel arms (2:1 ratio) among people ≥60 years old who live at home in southeastern France. A cluster consists of 10 people participating in a “workshop” (i.e., a collective intervention conducted at a local organization). We aim to include 45 workshops randomized into two groups: the intervention group (including 30 workshops) in the ALAPAGE program; and the waiting-list control group (including 15 workshops). Participants (expected total sample size: 450) will be recruited through both local organizations’ usual practices and an innovative active recruitment strategy that targets hard-to-reach people. We developed the ALAPAGE program based on existing workshops, combining a participatory and a theory-based approach. It includes a 7-week period with weekly collective sessions supported by a dietician and/or an adapted physical activity professional, followed by a 12-week period of post-session activities without professional supervision. Primary outcomes are dietary diversity (calculated using two 24-hour diet recalls and one Food Frequency Questionnaire) and lower-limb muscle strength (assessed by the 30-second chair stand test from the Senior Fitness Test battery). Secondary outcomes include consumption frequencies of main food groups and water/hot drinks, other physical fitness measures, overall level of physical activity, quality of life, and feelings of loneliness. Outcomes are assessed before the intervention, at 6 weeks and 3 months later. The process evaluation assesses the fidelity, dose, and reach of the intervention as its causal mechanisms (quantitative and qualitative data). Discussion This study aims to improve healthy aging while limiting social inequalities. We developed and evaluated the ALAPAGE program in partnership with major healthy aging organizations, providing a unique opportunity to expand its reach. Trial registration ClinicalTrials.gov Identifier: NCT05140330 , December 1, 2021. Protocol version: Version 3.0 (November 5, 2021).

Abstract Background The presence of bacteraemia in pneumococcal pneumonia in critically ill patients does not appear to be a strong independent prognostic factor in the existing literature. However, there may be a specific pattern of factors associated with mortality for ICU patients with bacteraemic pneumococcal community-acquired pneumonia (CAP). We aimed to compare the factors associated with mortality, according to the presence of bacteraemia or not on admission, for patients hospitalised in intensive care for severe pneumococcal CAP. Methods This was a post hoc analysis of data from the prospective, observational, multicentre STREPTOGENE study in immunocompetent Caucasian adults admitted to intensive care in France between 2008 and 2012 for pneumococcal CAP. Patients were divided into two groups based on initial blood culture (positive vs. negative) for Streptococcus pneumoniae. The primary outcome was hospital mortality, which was compared between the two groups using odds ratios according to predefined variables to search for a prognostic interaction present in bacterial patients but not non-bacteraemic patients. Potential differences in the distribution of serotypes between the two groups were assessed. The prognostic consequences of the presence or not of initial bi-antibiotic therapy were assessed, specifically in bacteraemic patients. Results Among 614 included patients, 274 had a blood culture positive for S. pneumoniae at admission and 340 did not. The baseline difference between the groups was more frequent leukopaenia (26% vs. 14%, p = 0.0002) and less frequent pre-hospital antibiotic therapy (10% vs. 16.3%, p = 0.024) for the bacteraemic patients. Hospital mortality was not significantly different between the two groups (p = 0.11). We did not observe any prognostic factors specific to the bacteraemic patient population, as the statistical comparison of the odds ratios, as an indication of the association between the predefined prognostic parameters and mortality, showed them to be similar for the two groups. Bacteraemic patients more often had invasive serotypes but less often serotypes associated with high case fatality rates (p = 0.003). The antibiotic regimens were similar for the two groups. There was no difference in mortality for patients in either group given a beta-lactam alone vs. a beta-lactam combined with a macrolide or fluoroquinolone. Conclusion Bacteraemia had no influence on the mortality of immunocompetent Caucasian adults admitted to intensive care for severe pneumococcal CAP, regardless of the profile of the associated prognostic factors.

Objectives: Summer intermittent sun exposure is a major risk factor for melanoma. Socioeconomic position, cognitive and psychosocial factors play a role in sun protection behaviors but the underlying mechanisms are unknown. This study aimed to measure the influence of educational level on sun protection behaviors in French summer vacationers on the Mediterranean coastline, and to identify the mediating psychosocial factors in this pathway.Methods: In summer 2019, French vacationers aged 12–55 staying in coastline campsites were asked about their holiday sun protection behaviors, their knowledge, attitudes, perceived control, and social norm relative to sun protection. A structural equation model measured the direct and indirect effects of educational level on protection behaviors via cognitive and psychosocial factors.Results: Sun protection during vacation increased with educational level. Theoretical knowledge partially mediated this association, from 22% to 86%, particularly for intermediate educational levels.Conclusion: Our results highlight the importance of implementing suitable sun prevention interventions for vacationers, especially those with a lower socioeconomic position. Improving theoretical knowledge around sun protection may be an important part of broader efforts to encouraging improved preventive behaviors.

BackgroundIn metastatic colorectal cancer (CRCm), fatigue is pervasive, reduces quality of life, and is negatively associated with survival. Its course is explained in part by psychosocial variables such as emotional distress, coping strategies, or perceived control. Thus, to reduce fatigue, psychosocial interventions appear to be relevant. In some cancers, Cognitive Behavioral Therapies (CBT) reduce fatigue. Hypnosis is also used as a complementary therapy to reduce the side effects of cancer. While CBT requires specific training often reserved for psychologists, hypnosis has the advantage of being increasingly practiced by caregivers and is therefore less expensive (Montgomery et al., 2007). On the other hand, CBT and hypnosis remain understudied in the CRC, do not focus on the symptom of fatigue and in Europe such programs have never been evaluated.ObjectivesImplementing an intervention in a healthcare setting is complex (e.g., economic and practical aspects) and recruiting participants can be challenging. The primary objective will therefore be to study the feasibility of two standardized interventions (hypnosis and CBT) that aim to reduce fatigue in patients with CRCm treated in a French cancer center.Methods and designA prospective, single-center, randomized interventional feasibility study, using mixed methods (both quantitative and qualitative). A total of 60 patients will be allocated to each intervention group [Hypnosis (n = 30) and CBT (n = 30)]. Participants will be randomized into two parallel groups (ratio 1:1). Both programs will consist of 6 weekly sessions focusing on the CRF management over a period of 6 weeks. Trained therapists will conduct the program combining 3 face-to-face sessions and 3 online sessions. The feasibility and experience of interventions will be evaluated by the outcome variables, including the adhesion rate, the reasons for acceptability, relevance or non-adherence, the satisfaction, the fatigue evolution (with ecological momentary assessments), and the quality of life. All questionnaires will be self-assessment using an online application from the cancer center.DiscussionResults will highlight the barriers/facilitators to the implementation of the program and the relevance of the program to the patients, and will be used to generate hypotheses for a randomized control trial.Clinical trial registrationClinicalTrials.gov Identifier: NCT04999306; https://clinicaltrials.gov/ct2/show/NCT04999306.

Abstract Background While aminoglycosides (AG) have been used for decades, debate remains on their optimal dosing strategy. We investigated the international practices of AG usage specifically regarding dosing and therapeutic drug monitoring (TDM) in critically ill patients. We conducted a prospective, multicentre, observational, cohort study in 59 intensive-care units (ICUs) in 5 countries enrolling all ICU patients receiving AG therapy for septic shock. Results We enrolled 931 septic ICU patients [mean ± standard deviation, age 63 ± 15 years, female 364 (39%), median (IQR) SAPS II 51 (38–65)] receiving AG as part of empirical (761, 84%) or directed (147, 16%) therapy. The AG used was amikacin in 614 (66%), gentamicin in 303 (33%), and tobramycin in 14 (1%) patients. The median (IQR) duration of therapy was 2 (1–3) days, the number of doses was 2 (1–2), the median dose was 25 ± 6, 6 ± 2, and 6 ± 2 mg/kg for amikacin, gentamicin, and tobramycin respectively, and the median dosing interval was 26 (23.5–43.5) h. TDM of C max and C min was performed in 437 (47%) and 501 (57%) patients, respectively, after the first dose with 295 (68%) patients achieving a C max/MIC > 8 and 353 (71%) having concentrations above C min recommended thresholds. The ICU mortality rate was 27% with multivariable analysis showing no correlation between AG dosing or pharmacokinetic/pharmacodynamic target attainment and clinical outcomes. Conclusion Short courses of high AG doses are mainly used in ICU patients with septic shock, although wide variability in AG usage is reported. We could show no correlation between PK/PD target attainment and clinical outcome. Efforts to optimize the first AG dose remain necessary. Trial registration Clinical Trials, NCT02850029, registered on 29th July 2016, retrospectively registered, https://www.clinicaltrials.gov

Context: At least 40% of cancers are linked to environmental or behavioral factors, and dietary behavior appears to be a major lever. Epidaure Market is a prevention initiative developed using a method for co-constructing health promotion initiatives and prevention programs that stratifies evidence from the scientific literature and combines it with experiential knowledge (DEVA, TPB, BCT). It promotes a sustainable diet (i.e., healthy, ecological and ethical nutrition) among 5th and 4th grade students during the crucial period of adolescence, when these behaviors are often far from the recommendations. Method: The protocol implemented was carried out in 72 middle school classes in the Montpellier and Dijon academies. The intervention included teaching sessions and a virtual supermarket game, integrated into the school curriculum and delivered by science teachers. Effectiveness is tested in a cluster randomized controlled trial with 3 evaluation times (pre- and post-intervention and 1 follow-up). The study also includes an implementation assessment, with process analysis and implementation elements, as well as a transferability assessment based on key functions (FIC model and Astaire grid). Expected outcomes: The study is still underway within the school. The primary expected outcome is a positive influence on the motives underlying food choices to move towards a sustainable diet. Secondary expectations involve changes in variables such as self-efficacy and perceived social norms, as well as an increase in knowledge about healthy eating. We also expect the qualitative approaches to provide information on the deployment process in the new territories. Discussion: The study aims not only to demonstrate the effectiveness of Epidaure Market, but also to identify the optimal conditions for its nationwide implementation in France's middle schools. Ultimately, the initiative aims to help reduce the incidence of cancer by promoting healthier eating habits among teenagers. [ABSTRACT FROM AUTHOR]

Purpose: The theory of planned behavior (TPB) has been criticized for not including interactions between the variables assumed to predict behavior. This study sought to test how TPB variables interact to predict physical activity (PA) in children. Method: Four hundred thirty-eight children (M[subscript age] = 8.6 years, SD = 1.6 years) completed a TPB questionnaire and a PA questionnaire at Time 1. The PA measure was repeated 2 months later. Path analyses were performed to test the hypothesized model including interaction terms between TPB variables. Simple slopes analyses were also carried out to examine the statistically significant interaction terms. Results: Path analyses confirmed the classical hypotheses of TPB (R[superscript 2] for intentions = 0.39, R[superscript 2] for PA = 0.12) and also demonstrated only statistically significant Attitudes × Perceived Behavioral Control and Subjective Norms × Attitudes interactions (R[superscript 2] change for intentions = 0.01, p = 0.009). Simple slopes analyses revealed that the strength of the association between perceived behavioral control and intentions was only statistically significantly higher (t = 2.18, p = 0.05, d = 0.34, 95% CI [0.03, 0.65]) when attitudes were high compared with when attitudes were low. The link between attitudes and intentions was only statistically significant at a low level of subjective norms but not at a high level. Conclusion: The integration of interaction effects between TPB variables did not increase for the variance of PA explained by the model. More research appears to be necessary to explore how the TPB could be augmented to better predict PA in children.

Abstract Background Recent population-based surveys have reported that large majorities of children in France, Europe and in the US are not complying with international physical activity (PA) guidelines. There is, therefore, a need to find programs that will improve children’s PA habits from an early age. Theory-based interventions that include school, family, and community involvement have the potential to generate a considerable increase in the PA level of children. The theory of planned behavior (TPB) is one of the most widely tested models of the factors influencing health-related behaviors. The Great Live and Move Challenge (GLMC) is an extended TPB-based intervention designed to promote PA in French primary school children aged 7–11 years. The objective of this paper is to describe the protocol of a randomized controlled trial to evaluate the effectiveness of the GLMC on the PA level of children. Methods This is a two-year cluster-randomized controlled trial comparing an intervention group to a control group, randomized into clusters (community of communes) and stratified by department (Hérault, Gard, Aude) and residential environment (urban, rural). The goal is to recruit 4000 children. The GLMC involves children and their parents, and multiple local grassroots partners, such as school teachers, municipal officials and policy stakeholders. The intervention will be delivered over 3.5 months per year for a two-year period. Pre- and post-intervention, children and parents will be asked to fulfill a questionnaire concerning current PA level, TPB variables (i.e., intentions, attitudes, subjective norms, perceived behavioral control) and other psychosocial variables (e.g., perceptions of activity opportunities). A subsample of 400 children will be proposed to wear an accelerometer (i.e., the Actigraph GT3X+). The primary hypothesis is that the GLMC intervention will increase the proportion of children achieving the World Health Organization’s recommended 60 min of moderate to vigorous PA per day by 15%. Discussion This study will evaluate the effectiveness of a multilevel, theory-based PA program and potentially provide valuable information for schools and public health officers looking for innovative PA programs. Trial registration ISRCTN:61116221, 19/06/2018.

Background: Sun exposure has short- and long-term adverse effects on eyes, skin, and the immune system. The most serious effect, melanoma, is largely attributable to natural ultraviolet radiation. Its prevalence is steadily increasing in fair-skinned populations in most European countries. Despite annual prevention campaigns, the French population continues to be overexposed to the sun and under-protected. Social and psychosocial characteristics may play an important role in sun protection determinants. Overexposure is partially motivated by a desire to tan oneself for aesthetic reasons. During summer, intense exposure constitutes a major risk factor for melanoma, making tourists a particularly high-risk population. Literature reviews concluded that appearance-based interventions highlighting the aesthetic effects of sun exposure on skin photoaging showed promise in terms of improving sun-exposure and sun-protection behaviors, especially among younger people, but that more rigorous studies were needed. In this context, we implemented the PRISME study to:- identify the determinants, in particular social and psychosocial, of sun-protection of French summer tourists visiting the Mediterranean coastline;- design two prevention interventions grounded in psychosocial theories;- compare the impact of both interventions on tourists' sun-protection behaviors, and identify the determinants influencing this impact.This paper presents the methodology of the PRISME study.Methods: During summer 2019, we conducted a cluster randomized crossover trial to compare two prevention interventions, one based on health-related messages (health effects information, phototype calculation), the other on appearance-related messages (photoaging information, ultraviolet photography), among French tourists aged 12–55 years old in coastline campsites in the French region of Occitanie. Both interventions were anchored in the theory of planned behavior and in the transtheoretical model. The interventions' impact was measured using face-to-face questionnaires and skin color measurements both immediately before and 4 days after the interventions. A second follow-up, using an online questionnaire, will be conducted in September 2020 to measure the longer-term effects of both interventions.Discussion: Despite certain study limitations, PRISME take into consideration several known methodological gaps. The study's results will enable to evaluate the efficacy of the promising appearance-based approach in France, and to identify vulnerable sub-populations and mechanisms to improve sun-protection behaviors of French tourists.