Pilot Randomised Controlled Trial of a Web-Based Intervention to Promote Healthy Eating, Physical Activity and Meaningful Social Connections Compared with Usual Care Control in People of Retirement Age Recruited from Workplaces

BackgroundLifestyle interventions delivered during the retirement transition might promote healthier ageing. We report a pilot randomised controlled trial (RCT) of a web-based platform (Living, Eating, Activity and Planning through retirement; LEAP) promoting healthy eating (based on a Mediterranean diet (MD)), physical activity (PA) and meaningful social roles.MethodsA single blinded, two-arm RCT with individual allocation. Seventy-five adult regular internet users living in Northeast England, within two years of retirement, were recruited via employers and randomised in a 2:1 ratio to receive LEAP or a ‘usual care’ control. Intervention arm participants were provided with a pedometer to encourage self-monitoring of PA goals. Feasibility of the trial design and procedures was established by estimating recruitment and retention rates, and of LEAP from usage data. At baseline and 8-week follow-up, adherence to a MD derived from three 24-hour dietary recalls and seven-day PA by accelerometry were assessed. Healthy ageing outcomes (including measures of physiological function, physical capability, cognition, psychological and social wellbeing) were assessed and acceptability established by compliance with measurement protocols and completion rates. Thematically analysed, semi-structured, qualitative interviews assessed acceptability of the intervention, trial design, procedures and outcome measures.ResultsSeventy participants completed the trial; 48 (96%) participants in the intervention and 22 (88%) in the control arm. Participants had considerable scope for improvement in diet as assessed by MD score. LEAP was visited a median of 11 times (range 1–80) for a mean total time of 2.5 hours (range 5.5 min– 8.3 hours). ‘Moving more‘, ‘eating well’ and ‘being social’ were the most visited modules. At interview, participants reported that diet and PA modules were important and acceptable within the context of healthy ageing. Participants found both trial procedures and outcome assessments acceptable.ConclusionsThe trial procedures and the LEAP intervention proved feasible and acceptable. Effectiveness and cost-effectiveness of LEAP to promote healthy lifestyles warrant evaluation in a definitive RCT.Trial RegistrationClinicalTrials.gov NCT02136381背景：在退休过渡期开展的生活方式干预或可助力健康老龄化。本研究报道了一项基于网络平台“LEAP（Living, Eating, Activity and Planning through retirement，退休后生活、饮食、活动与规划）”的先导随机对照试验（randomised controlled trial, RCT），该平台旨在推广基于地中海饮食（Mediterranean diet, MD）的健康饮食、身体活动（physical activity, PA）以及富有意义的社会角色构建。 方法：本研究为单盲、两组平行的个体随机对照试验。通过雇主招募75名居住在英格兰东北部、退休前两年内的成年网络用户，以2:1的比例随机分配至LEAP干预组或常规护理对照组。干预组参与者获配计步器，以辅助自我监测身体活动目标。通过估算招募率、保留率以及基于平台使用数据评估LEAP的可行性，确立本试验设计与流程的可行性。在基线及8周随访节点，通过三次24小时膳食回顾法及加速度计测量的7天身体活动数据，评估受试者对地中海饮食的依从性。同时评估健康老龄化相关结局指标（包括生理功能、身体能力、认知功能、心理与社会福祉等），并通过受试者对测量方案的依从性及完成率评估研究的可接受性。此外，通过半结构化质性访谈并采用主题分析法，评估受试者对干预措施、试验设计、流程及结局评估指标的接受度。 结果：共有70名参与者完成本试验，其中干预组48人（依从率96%），对照组22人（依从率88%）。通过地中海饮食评分评估可知，参与者的饮食状况存在较大改善空间。LEAP平台的中位访问次数为11次（范围1~80次），平均总使用时长为2.5小时（范围5.5分钟~8.3小时）。其中“适度活动”“健康饮食”与“社交参与”为访问量最高的模块。访谈结果显示，参与者认为饮食与身体活动模块在健康老龄化的语境下具有重要意义且易于接受。同时，参与者对试验流程及结局评估均表示认可。 结论：本试验流程与LEAP干预方案均具备可行性与可接受性。LEAP平台在推广健康生活方式方面的有效性与成本效益，有待在确证性随机对照试验中进一步评估。 试验注册：ClinicalTrials.gov NCT02136381