MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK
MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.
BMJ Open. 2019 Oct 28;9(10):e030902. doi: 10.1136/bmjopen-2019-030902.
Family-based physical activity (PA) interventions present a promising avenue to promote children's activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.
FRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families' website engagement will also be explored.
This study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.
ISRCTN12789422.
基于家庭的身体活动（PA）干预措施为促进儿童活动提供了一个有前途的途径；然而，高质量的实验研究却很缺乏。本文介绍了 FRESH（家庭报告健康的每一步）试验的方案，这是一种基于儿童的、基于家庭的 PA 干预措施，通过在线进行。
FRESH 是一项三臂、平行组、随机对照试验，采用 1:1:1 的分配比例，在基线后 8 周和 52 周进行随访评估。如果有至少一名小学生（7-11 岁）和至少一名负责该儿童的成年人愿意参加，则家庭有资格参加。家庭成员可以参加干预措施，而无需参加伴随的评估，反之亦然。在基线评估后，家庭将被随机分配到三个组之一：（1）FRESH；（2）计步器组或（3）无干预对照组。计步器组和 FRESH 组的所有家庭成员都将收到计步器和一般的 PA 促进信息。FRESH 家庭还可以访问干预网站；允许参与者选择步长挑战，以“旅行”到世界各地的目标城市，记录步数并跟踪他们虚拟环球旅行的进展。对照组家庭将不接受任何治疗。所有家庭成员都有资格参加评估，评估有两次随访（8 周和 52 周）。将在每个时间点收集身体（如，体能和血压）、心理社会（如，社会支持）和行为（如，客观测量的家庭 PA）措施。在 8 周的随访中，将进行混合方法的过程评估（问卷调查和家庭焦点小组），评估干预措施和评估的可接受性。还将探索 FRESH 家庭的网站参与情况。
这项研究获得了剑桥大学人文社会科学学院伦理委员会的批准。研究结果将通过同行评审的出版物、会议和参与家庭进行传播。
ISRCTN85070017。
