Bryant Maria, Burton Wendy, Collinson Michelle, Hartley Suzanne, Tubeuf Sandy, Roberts Kim, Sondaal Annemijn E C, Farrin Amanda J
1Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT UK.
2Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT UK.
Pilot Feasibility Stud. 2018 Jun 21;4:118. doi: 10.1186/s40814-018-0309-1. eCollection 2018.
In the UK and beyond, public funding is used to commission interventions delivered in public health early years settings aimed at improving health and well-being and reducing inequalities in order to promote school readiness. This is a key setting for obesity prevention programmes, which are often commissioned despite the limited evidence base. The HENRY (Health, Exercise, Nutrition for the Really Young) programme is an 8-week programme delivered to parents of preschool children, designed to support families to optimise healthy weight behaviours. Early evidence suggests that it may be effective, but a robust evaluation using a randomised controlled design has not been conducted. This study begins this process by evaluating the feasibility of conducting a multi-centre definitive trial to evaluate the effectiveness and cost-effectiveness of HENRY to prevent obesity in the early years.
This is a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents from 12 children's centres, based in two local authority areas. Within each of the two local authorities, three centres will be randomised to HENRY and three will be randomised to a control arm of standard care (usual provision of services within children's centres). We will explore HENRY commissioning, provision and delivery and assess the feasibility of local authority, centre and parent recruitment, the processes and time required to train and certify staff to deliver the intervention, the potential sources (and associated risk) of contamination and the feasibility of the trial procedures. Research includes a process evaluation, feasibility of cost-effectiveness evaluation, with progression to the definitive trial judged against pre-defined criteria.
This feasibility study will support the decision to proceed to, and the design of, a future definitive trial, providing an evidence base of an approach to prevent childhood obesity, which has been deemed attractive to all stakeholders, including parents. Given the widespread adoption of the intervention, this has the potential to impact on public health in the UK and beyond.
ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017Protocol date: 25th October 2017Protocol version: 4.0.
在英国及其他地区，公共资金被用于委托在早期公共卫生环境中实施干预措施，旨在改善健康和福祉，减少不平等现象，以促进儿童入学准备。这是肥胖预防计划的关键环境，尽管证据基础有限，但此类计划仍经常获得委托实施。HENRY（针对幼儿的健康、运动、营养）计划是一项为期8周的计划，面向学龄前儿童的家长，旨在支持家庭优化健康体重行为。早期证据表明该计划可能有效，但尚未进行使用随机对照设计的严格评估。本研究通过评估开展一项多中心确定性试验以评估HENRY预防早期肥胖的有效性和成本效益的可行性，开启了这一进程。
这是一项多中心、开放标签、两组、前瞻性、整群随机、对照的可行性研究，旨在从两个地方政府辖区的12个儿童中心招募120名家长。在两个地方政府中的每个辖区内，三个中心将被随机分配到HENRY组，另外三个中心将被随机分配到标准护理对照组（儿童中心内通常提供的服务）。我们将探索HENRY的委托、提供和实施情况，并评估地方政府、中心和家长招募的可行性，培训和认证工作人员实施干预措施所需的流程和时间，污染的潜在来源（及相关风险）以及试验程序的可行性。研究包括过程评估、成本效益评估的可行性，并根据预先定义的标准判断是否推进到确定性试验。
这项可行性研究将支持未来进行确定性试验的决策及其设计，提供一种预防儿童肥胖方法的证据基础，该方法已被包括家长在内的所有利益相关者认为具有吸引力。鉴于该干预措施的广泛采用，这有可能对英国及其他地区的公共卫生产生影响。
ClinicalTrials.gov标识符NCT03333733，于2017年11月6日注册
2017年10月25日
4.0
