Bryant Maria, Burton Wendy, Cundill Bonnie, Farrin Amanda J, Nixon Jane, Stevens June, Roberts Kim, Foy Robbie, Rutter Harry, Hartley Suzanne, Tubeuf Sandy, Collinson Michelle, Brown Julia
Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
Department of Nutrition, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.
Trials. 2017 Jan 24;18(1):40. doi: 10.1186/s13063-016-1732-3.
Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness.
METHODS/DESIGN: The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle.
This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot trial is planned to determine the practicality of undertaking a definitive trial to robustly evaluate the effectiveness and cost-effectiveness of the optimised intervention on childhood obesity prevention.
ClinicalTrials.gov identifier: NCT02675699 . Registered on 4 February 2016.
基于家庭的儿童肥胖预防干预措施依赖于父母采取行动改善家庭饮食及其他生活方式行为。吸引并留住大量父母参与的项目为改善公众健康提供了更好的机会，而且相较于那些未能吸引大量父母参与的项目，可能也更具成本效益。我们开发了一种基于理论的优化干预措施，以促进父母参与现有的儿童肥胖预防群体项目“HENRY”（面向幼儿的健康、运动与营养项目）。在此，我们描述一项关于评估该优化干预措施在父母参与度和成本效益方面有效性的提议。
方法/设计：“HENRY项目中优化家庭参与度”（OFTEN）试验是一项整群随机对照试验，在24个地方当局（约144个儿童中心）开展，这些地方当局目前正在实施HENRY项目。主要结局将是父母在HENRY项目中的注册和参与情况，通过常规收集的过程数据进行评估。成本效益将根据主要结局，利用可接受性曲线并通过了解HENRY项目专员为优化措施支付费用的意愿来呈现。次要结局包括优化措施的纵向影响、父母报告的婴儿水果和蔬菜摄入量（作为依从性的指标）以及其他父母报告的家庭习惯和生活方式。
这项创新性试验将为实施一种基于理论的优化干预措施提供证据，以促进父母参与HENRY项目，这是一个基于社区的儿童肥胖预防项目。研究结果将适用于在其他基于社区的环境中向父母提供的其他干预措施。本研究满足了项目专员、儿童中心和父母明确表达的需求，即优化HENRY项目在预防肥胖方面的潜在影响。计划随后开展一项整群随机对照试点试验，以确定进行一项确定性试验的可行性，从而有力地评估优化干预措施在预防儿童肥胖方面的有效性和成本效益。
ClinicalTrials.gov标识符：NCT02675699。于2016年2月4日注册。
