NCT Number: NCT03996551
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Guy's and St Thomas' Hospital, London, UK, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: through study completion, an average of 1 year
number of participants screened per month, and those unwilling to take part
Time frame: through study completion, an average of 1 year
number of participants recruited per month
Time frame: through study completion, an average of 1 year
willingness of participants to be randomized to each group
Time frame: through study completion, an average of 1 year
number of participants retained per month
Time frame: through study completion, an average of 1 year
number of participants retained and at end of study
Time frame: by three months
aim for 60% completion of sessions
Time frame: through study completion, an average of 1 year
the average time taken to complete study visits will be captured
Time frame: through study completion, an average of 1 year
the proportion of completed study visits for outcome measures will be calculated
Time frame: 12 months
the number of hospital admissions (non-elective, or elective staying >24 hours) will be captured
Time frame: 3 months
individual semi-structured interviews in a purposive sample from the treatment group
Time frame: 6 months
individual semi-structured interviews in a purposive sample of study participants
Time frame: baseline, 3 months and 12 months
body weight in kilograms will be recorded at the three study visits and the change will be calculated
Time frame: baseline, 3 months, 12 months
body mass index at each 3 study visits
Time frame: baseline, 3 months, 12 months
body composition will be measured at each of the 3 study visits
Time frame: baseline, 3 months, 12 months
QOL will be measured by the EQ5D questionnaire at each of the 3 study visits
Time frame: baseline, 3 months, 12 months
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-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
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
7 of the items measure physical fatigue, the maximum sub score is 21(high physical fatigue)
Time frame: baseline, 3 months, 12 months
4 of the items measure mental fatigue, the maximum sub score is 12 (high mental fatigue)
Time frame: at baseline, 3 months and 12 months
arterial stiffness will be measured by pulse wave velocity
Time frame: baseline, 3 months, 12 months
physical function will be assessed by the six minute walk test at each timepoint
King's College Hospital NHS Trust
Other
ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study. A Feasibility Randomised Controlled Trial.
Acronym: ExeRTiOn2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03699059
Behavior, Body Weight
London, United Kingdom
View Trial DetailsNCT06030609
Electrolyte Imbalance, Kidney Transplant; Complications
Bangkok, Thailand
View Trial DetailsNCT03206801
Kidney Transplant; Complications, Rejection of Renal Transplant
Adelaide, South Australia, Australia
View Trial DetailsNCT05836636
Kidney Transplant Infection, Kidney Transplant Rejection
Singapore
View Trial Details