Proportionate universalism intervention is effective for tackling nutritional social gradient in adolescents: the PRALIMAP-INÈS mixed randomised trial.

OBJECTIVE: This study aimed to investigate the effectiveness of proportionate universalism intervention to reduce the slope of the nutritional social gradient in adolescents. STUDY DESIGN: A mixed (experimental and quasi-experimental) multicentre trial. METHODS: Data from 985 adolescents of the PRALIMAP-INÈS trial (North-eastern France, 2012-2015) were analysed. For this, adolescents were split into five social classes according to the Family Affluence Scale: Highly Less Advantaged (H.L.Ad; n = 33), Less Advantaged (L.Ad; n = 155), Intermediate (Int; n = 404), Advantaged (Ad; n = 324) and Highly Advantaged (H.Ad; n = 69). The overweight care management was a standard care for all and a strengthened one adapted to the social class of adolescents. The main outcome was the 1-year change of the body mass index z-score (BMIz) slope. Other nutritional outcomes were BMI, ΔBMIp95 (BMI minus 95th percentile of the WHO reference), %BMIp95 (percent of 95th percentile of the WHO reference), leisure-time sport, consumption of fruits and vegetables and consumption of sugary foods and drinks. RESULTS: The inclusion data confirmed a weight social gradient expressed by a significant BMIz linear regression coefficient (ß = -0.09 [-0.14 to -0.04], P < 0.0001). The higher the social class, the lower the BMIz. The 1-year BMIz linear regression coefficient was -0.07 [-0.12 to -0.02], corresponding to a significant weight social gradient reduction of 23.3% (ß = 0.021 [0.001 to 0.041]; P = 0.04). Consistent results were found for other nutritional outcomes. CONCLUSIONS: PRALIMAP-INÈS shows that proportionate universalism intervention is effective to reduce the adolescents' nutritional social gradient and suggests that equitable health programmes and policies are a realistic goal.

[French version of The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, in a French law context]. / Version française des recommandations de la déclaration d'Ottawa sur la conception et la conduite éthique d'essais randomisés en clusters, dans le contexte législatif français.

INTRODUCTION: There is growing evidence on the ethical challenges raised by cluster randomized trials. This specificity is not reflected in the legal texts regulating research, which creates difficulties for researchers implementing these experimental designs. The Ottawa Statement (Weijer et al. 2012) aims to provide detailed guidance on the ethical design, conduct and assessment of cluster trials. More broadly aims to help research stakeholders and decision-makers to make informed ethical decisions regarding the particularity of these experimental designs. It seems that this international statement, written in English, is not sufficiently accessible to all of the French professionals involved in health research. The aim of this article is to provide these professionals with a contextualized and illustrated French translation of the "Ottawa statement". METHOD: . The "complex design" working group of the RECaP network (Research in Clinical Epidemiology and Public Health), carried out this work. A first version was discussed by the authors in several meetings. It was completed by contextual explanations and examples of French studies currently conducted by the authors. The final version was obtained by consensus and validated by the group. RESULTS: . This work reports 15 recommendations grouped into 7 key questions: How to justify cluster design? How to submit an article to an ethics committee? How to identify research participants? How and when to obtain informed consent? Who are the gatekeepers? How to assess benefits and harm? How to protect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommendations are explained and detailed through concrete examples. CONCLUSION: Without interfering with current French laws, this work provides a framework for the organization, conduct and ethical assessment of cluster randomized trials in France. In the present-day context, it is essential that all concerned groups can base their decisions on recommendations in line with the elementary principles of health research ethics.

Economic evaluation of a school-based strategy to prevent overweight and obesity in French adolescents: insights from the PRALIMAP randomised trial.

OBJECTIVES: This study aimed to provide cost-effectiveness and budget impact analyses of a school-based overweight/obesity screening and care prevention strategy among adolescents. STUDY DESIGN: Cost-effectiveness and budget impact analyses. METHODS: Data from 3538 adolescents who participated in a school-based randomised controlled trial in the Northeast of France were used. Costs (from a public payer's perspective) included screening for overweight and obesity and subsequent care. Effectiveness was measured as the change in body mass index (kilogram per square metre), prevalence of overweight/obesity, moderate physical activity energy expenditure, duration and frequency and total sitting time. The incremental cost-effectiveness ratio was calculated, and a budget impact analysis was conducted. RESULTS: The screening and care strategy resulted in an incremental cost-effectiveness ratio of €1634.48 per averted case of overweight/obesity and €255.43 per body mass index unit decrease. The costs for increasing moderate physical activity by 1000 metabolic equivalent of task-min/week, duration by 60 min/week and frequency 1 day/week were €165.28, €39.21 and €93.66 per adolescent, respectively. Decreasing total sitting time by 60 min/week had a cost of €8.49 per adolescent. The cost of implementing the strategy nationally was estimated to be €50.1 million with a payback period from 3.6 to 7.3 years. CONCLUSIONS: The screening and care strategy could be an efficient way to prevent overweight and obesity among adolescents. Future studies should investigate how the current results could be achieved in schools with different settings and thus justify its relevance for overweight and obesity prevention to policy-makers.

Opportunistic screening for osteoporosis using thoraco-abdomino-pelvic CT-scan assessing the vertebral density in rheumatoid arthritis patients.

INTRODUCTION: Screening for osteoporosis is crucial in rheumatoid arthritis (RA) patients. The aim of this study was to assess the value of thoraco-abdomino-pelvic CT-derived bone mineral density (BMD) results in L1, compared to dual energy X-ray absorptiometry (DXA) results for osteoporosis screening in rheumatoid arthritis patients. METHODS: Consecutive RA patients who underwent a CT-scan and DXA within a 2-year period were retrospectively included. The CT sagittal images were then evaluated for vertebral fractures from T4 to L5 using the Genant classification. The CT-attenuation values (in Hounsfield units (HU)) of trabecular bone in L1 were measured on axial images and compared to the DXA results. RESULTS: This study included 105 patients (mean age 61.1 years (± 9.5), 78.1% women). There were 28 patients (26.7%) with DXA-defined osteoporosis and 32 (30%) with osteoporotic fractures (vertebral and/or non-vertebral). The CT assessment indicated that the mean (SD) vertebral L1 attenuation was 142.2 HU (± 18.5). The diagnostic performance for the vertebral CT-attenuation measurement was acceptable: the AUC was 0.67 for predicting osteoporotic fractures and of 0.69 for predicting vertebral fractures. Among patients with osteoporotic fractures, there were 23 (74%) patients categorized as osteoporotic with a L1 CT-attenuation of 135 HU or less, whereas there were only 13 patients (42%) identified by DXA. CONCLUSION: CT offers a combined opportunistic screening for osteoporosis by assessing both vertebral fractures and bone density on routine CT-scans. This approach may be particularly interesting for RA patients with a high osteoporosis risk.

[Socioeconomic profile and smoking among adolescents in vocational training]. / Profil socioéconomique et tabagisme chez les adolescents en centre de formation des apprentis.

BACKGROUND: Targeted interventions among vulnerable youth populations represent an important approach to the reduction of health inequalities. We must, however, ensure that impacts are not unequally distributed according to the range of resources available to them. We explore these concerns among youth in vocational training to be enrolled in a smoking cessation intervention by describing (1) their socio-economic profile and (2) the association between their socioeconomic characteristics, their smoking practices, and key factors that could be targeted in interventions. METHODS: A total of 234 young people aged 15-20 years were recruited in three centers in the Lorraine region in France in 2016-2017 as part of the Social Network and Tobacco Cessation (Réseau social et sevrage tabagique [RESIST]) study. We measured participants' socio-economic characteristics using their parents' education and occupational grade. We examined the associations of these characteristics with participants' smoking habits, intention to quit, nicotine dependence, presence of smokers in their network, and representation of a young smoker. We examined the associations between variables with bivariate tests depending on the nature of the variables. RESULTS: Participants were more likely to be from a socio-professional background more modest than the national average (56% versus 33%), but still exhibited considerable socioeconomic variability. Smoking status did not vary significantly according to the educational level of the participants' parents (from 52% to 57%, P=0.78) or occupational grade (from 52% to 58%, P=0.35). Compared to participants whose parents had completed a professional or pre-university degree, participants with parents in the lowest education category were less likely to report not intending to quit (P=0.01) and more likely to report seriously considering to quit in the next six months (P=0.03) and to have already tried to quit but failed (P=0.01). CONCLUSION: It is tempting to define youth in vocational training as a homogeneous group, especially when they share the same school environment, employment status, and income. Our results, however, highlight substantial variability in their socioeconomic profiles and smoking characteristics. Researchers are encouraged to further consider these equity issues to contribute to the reduction of health inequalities.