ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study
- Conditions
- Weight GainKidney Transplant; Complications
- Interventions
- Behavioral: ExeRTiOn online resource
- Registration Number
- NCT03996551
- Lead Sponsor
- King's College Hospital NHS Trust
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- age 18 or above
- able to provide written consent
- less than 3 months post kidney transplant
- access to the internet connected computer, tablet, laptop or smartphone
- a body mass index greater than or equal to 18.5 (healthy range)
- age < 18
- current pregnancy
- unstable medication condition such as uncontrolled angina
- participation in a recent structured exercise programme in the last 3 months
- BMI of less than 18.5 (classified as underweight)
- significant cognitive impairment preventing them from engaging with the online resource
- unable to complete the resource in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group ExeRTiOn online resource This group will receive access to the 12-week kidney transplant specific weight gain prevention online resource (ExeRTiOn online resource). After the 12 weeks, they will be offered the option to continue using the website up until the completion of the study (12 months)
- Primary Outcome Measures
Name Time Method Feasibility- proportion of participants willing to be randomized through study completion, an average of 1 year willingness of participants to be randomized to each group
feasibility- total retention of participants over the trial period through study completion, an average of 1 year number of participants retained and at end of study
Feasibility- screening of participants through study completion, an average of 1 year number of participants screened per month, and those unwilling to take part
feasibility- monthly retention of participants over the trial period through study completion, an average of 1 year number of participants retained per month
feasibility-adherence to ExeRTiOn online resource (intervention group) by three months aim for 60% completion of sessions
feasibility- time taken to complete all study visits through study completion, an average of 1 year the average time taken to complete study visits will be captured
feasibility- adherence to study visits throughout the trial through study completion, an average of 1 year the proportion of completed study visits for outcome measures will be calculated
feasibility- qualitative experience of participants using the online resource 3 months individual semi-structured interviews in a purposive sample from the treatment group
feasibility- qualitative experience of participants participation in the trial 6 months individual semi-structured interviews in a purposive sample of study participants
Feasibility- recruitment of participants into the trial through study completion, an average of 1 year number of participants recruited per month
feasibility- safety throughout the trial 12 months the number of hospital admissions (non-elective, or elective staying \>24 hours) will be captured
- Secondary Outcome Measures
Name Time Method body mass index over the 12 month trial baseline, 3 months, 12 months body mass index at each 3 study visits
self reported self-efficacy for physical exercise scale over the 12 month trial 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.
Total score self reported fatigue via the Chalder Fatigue Questionnaire over the 12 months 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).
body composition over the 12 month trial baseline, 3 months, 12 months body composition will be measured at each of the 3 study visits
quality of life (self-reported) over the 12 month trial baseline, 3 months, 12 months QOL will be measured by the EQ5D questionnaire at each of the 3 study visits
change in body weight in kilograms over the trial baseline, 3 months and 12 months body weight in kilograms will be recorded at the three study visits and the change will be calculated
Mental fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months baseline, 3 months, 12 months 4 of the items measure mental fatigue, the maximum sub score is 12 (high mental fatigue)
physical function over the 12 month trial baseline, 3 months, 12 months physical function will be assessed by the six minute walk test at each timepoint
Physical fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months baseline, 3 months, 12 months 7 of the items measure physical fatigue, the maximum sub score is 21(high physical fatigue)
arterial stiffness over the 12 month trial at baseline, 3 months and 12 months arterial stiffness will be measured by pulse wave velocity
self reported self-efficacy for nutrition scale over the 12 month trial 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.
Trial Locations
- Locations (2)
King's College Hospital
🇬🇧London, UK, United Kingdom
Guy's and St Thomas' Hospital
🇬🇧London, UK, United Kingdom