Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France.
Trials. 2010 Dec 6;11:119. doi: 10.1186/1745-6215-11-119.
Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'ALImentation et de l'Activité Physique) trial aims to evaluate the effectiveness for these conditions of 3 health promotion strategies--educational, screening and environmental--applied singly or in combination in high schools over a 2-year intervention period.
PRALIMAP is a stratified 2 × 2 × 2 factorial cluster randomised controlled trial including 24 state high schools in Lorraine, northeastern France, in 2 waves: 8 schools in 2006 (wave 1) and 16 in 2007 (wave 2). Students entering the selected high schools in the 4 academic years from 2006 to 2009 are eligible for data collection. Interventional strategies are organized over 2 academic years. The follow-up consists of 3 visits: at the entry of grade 10 (T0), grade 11 (T1) and grade 12 (T2). At T0, 5,458 (85.7%) adolescents participated. The educational strategy consists of nutritional lessons, working groups and a final party. The screening strategy consists in detecting overweight/obesity and eating disorders in adolescents and proposing, if necessary, an adapted care management program of 7 group educational sessions. The environmental strategy consists in improving dietary and physical activity offerings in high schools and facilities, especially catering. The main outcomes are body size evolution over time, nutritional behaviour and knowledge, health and quality of life. An evaluation process documents how each intervention strategy is implemented in the schools and estimates the dose of the intervention, allowing for a per protocol analysis after the main intention-to-treat analysis.
PRALIMAP aims at improving the prevention and management of overweight and obesity in adolescents by translating current evidence into public health practice. Particular attention is paid to clustering, multiple factorials and long-term duration to address common pitfalls in health promotion trials. The results should inform how best to implement, in a school environment, effective nutrition prevention programs targeting adolescents who are at a point their lives when they develop responsibilities and empowerment for health attitude behaviours.
This trial is registered at ClinicalTrials.gov under NCT00814554.
鉴于过去十年青少年超重和肥胖患病率的增加，迫切需要针对这些情况制定有效的预防策略。PRALIMAP（促进饮食和体育活动）试验旨在评估在 2 年的干预期间，在高中应用 3 种健康促进策略（教育、筛查和环境）的单一或组合对这些情况的有效性。
PRALIMAP 是一项分层 2×2×2 析因聚类随机对照试验，包括法国东北部洛林的 24 所州立高中，分 2 个波次进行：2006 年 8 所（波 1）和 2007 年 16 所（波 2）。在 2006 年至 2009 年的 4 个学年中，符合条件的学生将进入所选高中就读。干预策略组织了 2 个学年。随访包括 3 次就诊：在 10 年级（T0）、11 年级（T1）和 12 年级（T2）。在 T0，有 5458 名（85.7%）青少年参与。教育策略包括营养课程、工作组和最后的派对。筛查策略包括检测青少年超重/肥胖和饮食失调，并在必要时提出适应护理管理方案，包括 7 个小组教育课程。环境策略包括改善高中和设施的饮食和体育活动供应，特别是餐饮。主要结局是随时间的身体大小变化、营养行为和知识、健康和生活质量。一个评估过程记录了每个干预策略在学校中的实施情况，并估计了干预的剂量，以便在主要意向治疗分析后进行方案分析。
PRALIMAP 旨在通过将当前的证据转化为公共卫生实践，改善青少年超重和肥胖的预防和管理。特别关注聚类、多因素和长期持续时间，以解决健康促进试验中的常见陷阱。结果将为如何在学校环境中实施针对青少年的有效营养预防计划提供信息，这些青少年正处于他们发展健康态度和行为的责任和赋权阶段。
该试验在 ClinicalTrials.gov 注册，编号为 NCT00814554。
