The primary aim of this trial is to assess the feasibility of a novel online weight gain prevention resource for new kidney transplant recipients at two London transplant clinics. A previous study conducted by the research team titled 'ExeRTiOn' provided usability feedback that led to revisions of this online resource in a purposive sample of kidney transplant recipients (n=11) and transplant multidisciplinary team members (n=6).
This current study aims to recruit a sample of new kidney transplant recipients (n=50) from two transplant sites in London. Participants will be randomized to either the 12-week kidney transplant specific novel online weight gain prevention resource (n=25) or usual care (n=25). All participants will be assessed at baseline, 12 weeks and 12 months. The primary outcome of this study is feasibility (screening, recruitment, randomization, retention, adherence to the intervention and adherence to the study visits). The research team will also assess the ability to collect measures for a definitive study (body weight, body mass index, body composition, quality of life, self-efficacy, fatigue, arterial stiffness and physical function). A nested qualitative study will capture participant experience at two time points during this 12 month trial. At 3 months semi-structured individual interviews will be conducted in a purposive approximately 6 to 10 of the intervention participants until data saturation is achieved. These interviews will assess the experience of using the online intervention. At 6 months a purposive sample of approximately 16 participants from both groups will complete individual semi-structured interviews to assess the experiences of participating in this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
17
This is a 12-week online resource, specifically designed for new kidney transplant recipients. It includes dietary advice, physical activity advice, and recognized behavior change techniques. The participant will be monitored by a specialist physiotherapist and will receive messages of encouragement a 6 weeks and 12 weeks.
Guy's and St Thomas' Hospital
London, UK, United Kingdom
King's College Hospital
London, UK, United Kingdom
Feasibility- screening of participants
number of participants screened per month, and those unwilling to take part
Time frame: through study completion, an average of 1 year
Feasibility- recruitment of participants into the trial
number of participants recruited per month
Time frame: through study completion, an average of 1 year
Feasibility- proportion of participants willing to be randomized
willingness of participants to be randomized to each group
Time frame: through study completion, an average of 1 year
feasibility- monthly retention of participants over the trial period
number of participants retained per month
Time frame: through study completion, an average of 1 year
feasibility- total retention of participants over the trial period
number of participants retained and at end of study
Time frame: through study completion, an average of 1 year
feasibility-adherence to ExeRTiOn online resource (intervention group)
aim for 60% completion of sessions
Time frame: by three months
feasibility- time taken to complete all study visits
the average time taken to complete study visits will be captured
Time frame: through study completion, an average of 1 year
feasibility- adherence to study visits throughout the trial
the proportion of completed study visits for outcome measures will be calculated
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Time frame: through study completion, an average of 1 year
feasibility- safety throughout the trial
the number of hospital admissions (non-elective, or elective staying \>24 hours) will be captured
Time frame: 12 months
feasibility- qualitative experience of participants using the online resource
individual semi-structured interviews in a purposive sample from the treatment group
Time frame: 3 months
feasibility- qualitative experience of participants participation in the trial
individual semi-structured interviews in a purposive sample of study participants
Time frame: 6 months
change in body weight in kilograms over the trial
body weight in kilograms will be recorded at the three study visits and the change will be calculated
Time frame: baseline, 3 months and 12 months
body mass index over the 12 month trial
body mass index at each 3 study visits
Time frame: baseline, 3 months, 12 months
body composition over the 12 month trial
body composition will be measured at each of the 3 study visits
Time frame: baseline, 3 months, 12 months
quality of life (self-reported) over the 12 month trial
QOL will be measured by the EQ5D questionnaire at each of the 3 study visits
Time frame: baseline, 3 months, 12 months
self reported self-efficacy for nutrition scale over the 12 month trial
self-efficacy for nutrition will be measured via the self-efficacy scale at each of the 3 study visits. The scale has 5 statements/questions. The user selects a number from 1 to 4, with 1 being very uncertain and 4 being very certain for each of the five statements. The highest score (higher self-efficacy) is 20, the lowest score (low self-efficacy) is 5.
Time frame: baseline, 3 months, 12 months
self reported self-efficacy for physical exercise scale over the 12 month trial
self-efficacy for physical exercise will be measured via this self-efficacy scale at each of the 3 study visits. The scale has 5 statements/questions. The user selects a number from 1 to 4, with 1 being very uncertain and 4 being very certain for each of the five statements. The highest score (higher self-efficacy) is 20, the lowest score (low self-efficacy) is 5.
Time frame: baseline, 3 months, 12 months
Total score self reported fatigue via the Chalder Fatigue Questionnaire over the 12 months
self-reported fatigue will be measured using the Chalder Fatigue scale. It has 11 items, 7 measure physical fatigue and 4 measure mental fatigue. The user rates each question on a likert scoring system 0-3, with the maximum score being 33 (high fatigue).
Time frame: baseline, 3 months, 12 months
Physical fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months
7 of the items measure physical fatigue, the maximum sub score is 21(high physical fatigue)
Time frame: baseline, 3 months, 12 months
Mental fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months
4 of the items measure mental fatigue, the maximum sub score is 12 (high mental fatigue)
Time frame: baseline, 3 months, 12 months
arterial stiffness over the 12 month trial
arterial stiffness will be measured by pulse wave velocity
Time frame: at baseline, 3 months and 12 months
physical function over the 12 month trial
physical function will be assessed by the six minute walk test at each timepoint
Time frame: baseline, 3 months, 12 months