PRALIMAP-INESAccès aux soins pour les adolescents en surpoids et obèses au lycée
Cette étude vise à évaluer l'impact de l'accès aux soins sur la réduction du surpoids et de l'obésité chez les adolescents du secondaire en mesurant les changements de l'indice de masse corporelle sur une période de deux ans.
Standard care management
+ Standard care management
+ The strengthened care management
Poids Corporel+5
+ Troubles de la Nutrition
+ Maladies nutritionnelles et métaboliques
Étude de prévention
Résumé
Date de début de l'étude : 1 avril 2012
Date à laquelle le premier participant a commencé l'étude.Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial confirmed major social inequalities in overweight and obesity frequency in adolescents in grade 10. The trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management strategy for socially less advantaged adolescents in school in the short and long term (just after the intervention and 1 year later) has an equivalent effect as a standard-care management strategy on decreasing the prevalence of overweight and obesity among socially advantaged adolescents. Hypothesis: A strengthened overweight and obesity care management strategy for overweight and obesity (risk factors of cancer) can improve care access for socially less advantaged adolescents and maintain social equality in terms of overweight and obesity prevalence. Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial (one randomised part and one non-randomised part) of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013, 2013-2014 and 2014-2015. After a session to detect overweight and obese adolescents, the social status of included adolescents as "advantaged" or "less advantaged" is determined. Adolescents classified as advantaged are allocated to the standard-care management and those less advantaged are randomized to standard-care management or strengthened-care management. The standard-care management consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The team consists of physicians, dietitians, psychologists and sports educators from the AVRS Association. The content of sessions was validated in the PRALIMAP trial. The strengthened-care management consists of 5 collective sessions with the same standard operating procedure as the standard-care management with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings (adjusting the care management according to the social status). Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention = T0), at the end of grade 9 or 10 (at the end of the intervention = T1) and at the end of grade 10 or 11 (1 year after the intervention = T2). T1 measurement allows for evaluating the short-term effect of the intervention and T2, the long-term effect of a 1-year break from the intervention. Data on participation and from questionnaires, as well as focus group and activity reports, necessary for evaluation, are collected during the trial. Expected results: With this trial, the investigators expect to confirm the effectiveness of overweight and obesity care management for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight and obesity care.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.1689 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 13 à 17 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion criteria Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and be in a general, technological or vocational course, Aged ≤ 18 years old, not giving written refusal to participate in the trial, able to complete a questionnaire, overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria (for waist circumference) and/or have a high eating disorder score, and/or express the need for management of excess weight, confirmed as corresponding to the 4 previous inclusion criteria by the physician, with elimination of adolescents with false-positive BMI (particularly athletic adolescents), agree to an overweight and obesity care management program.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
ExpérimentalGroupe III
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site