Castle Ellen M, Dijk Giulia, Asgari Elham, Shah Sapna, Phillips Rachel, Greenwood James, Bramham Kate, Chilcot Joseph, Greenwood Sharlene A
Therapies Department, King's College Hospital, NHS Foundation Trust, London, United Kingdom.
King's Kidney Care, King's College Hospital, London, United Kingdom.
Front Nutr. 2022 May 23;9:887580. doi: 10.3389/fnut.2022.887580. eCollection 2022.
Half of kidney transplant recipients (KTRs) gain more than 5% of their body weight in the first year following transplantation. KTRs have requested support with physical activity (PA) and weight gain prevention, but there is no routine care offered. There are few high-quality studies investigating the clinical value of diet, PA or combined interventions to prevent weight gain. The development and evaluation of theoretically informed complex-interventions to mitigate weight gain are warranted. The aims of this mixed-methods randomized controlled trial (RCT) were to explore the feasibility, acceptability and user-experience of a digital healthcare intervention (DHI) designed to prevent post-transplant weight gain, in preparation for a large multi-center trial. New KTRs (<3 months) with access to an internet compatible device were recruited from a London transplant center. The usual care (UC) group received standard dietary and PA advice. The intervention group (IG) received access to a 12-week DHI designed to prevent post-transplant weight gain. Primary feasibility outcomes included screening, recruitment, retention, adherence, safety and hospitalizations and engagement and experience with the DHI. Secondary outcomes (anthropometrics, bioimpedance, arterial stiffness, 6-minute walk distance and questionnaires) were measured at baseline, 3- and 12-months. 38 KTRs were screened, of which 32 (84.2%) were eligible, and of those 20 (62.5%) consented, with 17 participants (85%) completing baseline assessment (Median 49 years, 58.8% male, Median 62 days post-transplant). Participants were randomized using a computer-generated list ( = 9 IG, = 8 UC). Retention at 12-months was 13 (76.4%) ( = 6 IG, = 7 UC). All progression criteria were achieved. There were no associated adverse events. Reflexive thematic analysis revealed four themes regarding trial participation and experience whilst using the DHI. Halting recruitment due to COVID-19 resulted in the recruitment of 40% of the target sample size. Mixed-methods data provided important insights for future trial design. A definitive RCT is warranted and welcomed by KTRs.
www.clinicalTrials.gov, identifier: NCT03996551.
一半的肾移植受者（KTR）在移植后的第一年体重增加超过其体重的5%。KTR要求在身体活动（PA）和预防体重增加方面获得支持，但目前没有提供常规护理。很少有高质量的研究调查饮食、PA或联合干预措施预防体重增加的临床价值。因此，开展并评估理论依据充分的复杂干预措施以减轻体重增加是很有必要的。这项混合方法随机对照试验（RCT）的目的是探索一种旨在预防移植后体重增加的数字医疗干预（DHI）的可行性、可接受性和用户体验，为大型多中心试验做准备。从伦敦一家移植中心招募了能够使用互联网兼容设备的新KTR（移植后<3个月）。常规护理（UC）组接受标准的饮食和PA建议。干预组（IG）可以使用一个为期12周的DHI，该DHI旨在预防移植后体重增加。主要可行性结果包括筛查、招募、留存率、依从性、安全性、住院情况以及对DHI的参与度和体验。次要结果（人体测量学、生物电阻抗、动脉僵硬度、6分钟步行距离和问卷调查）在基线、3个月和12个月时进行测量。共筛查了38名KTR，其中32名（84.2%）符合条件，其中20名（62.5%）同意参与，17名参与者（85%）完成了基线评估（中位年龄49岁，男性占58.8%，移植后中位时间62天）。参与者使用计算机生成的列表进行随机分组（IG组 = 9名，UC组 = 8名）。12个月时的留存率为13名（76.4%）（IG组 = 6名，UC组 = 7名）。所有进展标准均已达成。没有相关不良事件。反思性主题分析揭示了关于试验参与和使用DHI体验的四个主题。由于新冠疫情停止招募导致招募人数为目标样本量的40%。混合方法数据为未来试验设计提供了重要见解。一项确定性的RCT是有必要的，并且受到KTR的欢迎。
