The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial

Abstract

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 (n = 9 IG, n = 8 UC). Retention at 12-months was 13 (76.4%) (n = 6 IG, n = 7 UC). All a priori 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.

Clinical trial registration: www.clinicalTrials.gov, identifier: NCT03996551.

Keywords: behavior change; kidney transplantation; physical activity; web-based intervention; weight gain prevention.

Figure 1

Feasibility CONSORT diagram. ^aIndicates the recruitment window (3rd September 2019–15th March 2020 for KCH and 19th February−15th March 2020 for GSTT), ^bindicates potential participants at KCH who were eligible days before recruitment was put on hold due to Coronavirus disease 2019 (COVID-19) on the 15th March 2020, ^cdemonstrates the 3 potential participants at KCH who were given patient information sheets but unable to consent due to the first wave of COVID-19, and ^dindicates 3 participants who consented at GSTT but unfortunately due to pausing of recruitment, became ineligible and were therefore not baselined or randomized. KTR, kidney transplant recipients; PI, Principal Investigator; KCH, King's College Hospital; GSTT, Guy's and St Thomas' Hospital; ESL, English as a second language; TF, transfer; BMI, body mass index; ITU, Intensive Care Unit.

Figure 2

Data series of individual and median body weight values for IG participants (n = 9). Individual data series for participants in the intervention group depicted by the pale blue lines. Median depicted by darker blue line, with IQR error bars. Median was calculated from all recorded data at each assessment point. n = 9 at baseline, n = 8 at 3-months, and n = 6 at 12-months.

Figure 3

Data series of individual and median body weight values for UC participants (n = 8). Individual data series for participants in the usual care group are depicted by the pale blue lines. Median depicted by darker blue line, with IQR error bars. Median was calculated from all recorded data at each assessment point. n = 8 at baseline, n = 7 at 3-months, and n = 7 at 12-months.

Figure 4

Thematic map from reflexive thematic analysis (n = 13). Key themes are represented in different colors. The research question is shown at the center of the diagram, with outward branching themes (T1 to T4), and subthemes from the qualitative analysis. The * in Theme 2 above depicts the first wave of COVID-19 and the shielding enforced to Kidney Transplant Recipients (23rd March 2020 to the 1st of August 2020). Ax, assessment; comms, communication; DHI, digital health intervention; edu, education; PA, physical activity; PT, physiotherapist; tech, technical; 6MWT, six-minute walk test.