Bryant Maria, Collinson Michelle, Burton Wendy, Stamp Elizabeth, Schofield Holly, Copsey Bethan, Hartley Suzanne, Webb Edward, Farrin Amanda J
Department of Health Sciences, University of York, York, YO10 5DD, UK.
Hull York Medical School, University of York, York, YO10 5DD, UK.
Pilot Feasibility Stud. 2021 Feb 26;7(1):59. doi: 10.1186/s40814-021-00798-z.
Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted. We initiated a systematic evaluation of HENRY by studying the feasibility of conducting a multi-centre definitive trial to evaluate its effectiveness and cost-effectiveness to prevent obesity. Objectives were to assess the feasibility of recruiting local authorities, centres and parents; test processes and time required to train and certify intervention staff; explore HENRY commissioning processes; identify potential sources (and associated impact) of contamination; and consider the feasibility of trial procedures.
We conducted a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study, with embedded process evaluation and pre-defined criteria for progression to definitive trial. We sought to recruit 120 parents from 12 children's centres, across two UK local authority (government) areas. Within each local authority, we planned to randomise three centres to HENRY and three to 'standard care' control. Our plan was to collect data in family homes at baseline and 12 months, including parent and child height and weight, and parent-reported questionnaires on self-efficacy, feeding, eating habits, quality of life and resource use. Contamination, implementation and study acceptability were explored using parent interviews.
We recruited two local authorities and 12 children's centres within eight months. One hundred and seventeen parents were recruited (average 3.9 parents per programme) and follow-up data were collected from 85% of participants. Process data from 20 parents and 24 members of staff indicate that both would benefit from more detail about their involvement as participants, but that methods were acceptable. Contamination was likely, though the impact of this on behaviour was unclear.
Our findings indicate that a cluster RCT of HENRY to assess its effect on childhood obesity prevention is feasible. This study has allowed us to design a pragmatic definitive trial with minimal bias, taking account of lessons learnt from conducting evaluation research in public health settings.
ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.
尽管证据有限，但仍经常委托开展基于社区的肥胖预防干预措施。HENRY（针对幼儿的健康、运动、营养）是一项面向英国各地学龄前儿童家长的项目。早期证据表明它可能有效，但尚未进行严格评估。我们通过研究开展多中心确定性试验以评估其预防肥胖的有效性和成本效益的可行性，启动了对HENRY的系统评价。目标是评估招募地方当局、中心和家长的可行性；测试培训和认证干预人员所需的流程和时间；探索HENRY的委托流程；确定潜在的污染来源（及相关影响）；并考虑试验程序的可行性。
我们开展了一项多中心、开放标签、两组、前瞻性、整群随机、对照的可行性研究，纳入过程评价以及向确定性试验推进的预定义标准。我们试图从英国两个地方当局（政府）辖区的12个儿童中心招募120名家长。在每个地方当局内，我们计划将三个中心随机分配到HENRY组，三个中心分配到“标准护理”对照组。我们计划在基线和12个月时在家庭中收集数据，包括家长和孩子的身高和体重，以及家长报告的关于自我效能、喂养、饮食习惯、生活质量和资源使用的问卷。通过家长访谈探索污染、实施情况和研究可接受性。
我们在八个月内招募了两个地方当局和12个儿童中心。招募了117名家长（每个项目平均3.9名家长），并从85%的参与者那里收集了随访数据。来自20名家长和24名工作人员的过程数据表明，双方都将从关于他们作为参与者参与情况的更多细节中受益，但方法是可接受的。污染很可能存在，尽管其对行为的影响尚不清楚。
我们的研究结果表明，开展一项关于HENRY对预防儿童肥胖影响的整群随机对照试验是可行的。这项研究使我们能够设计一项务实的确定性试验，将偏差降至最低，同时考虑到在公共卫生环境中进行评价研究所吸取的经验教训。
ClinicalTrials.gov标识符NCT03333733，于2017年11月6日注册。
