Kidney Transplant; Complications, Weight Gain
Conditions
Keywords
kidney transplant, weight gain prevention, behavior change techniques, dietary advice, physical activity advice
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.
Interventions
BEHAVIORALExeRTiOn online resource
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.
Sponsors
Kidney Research U.K.
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility- qualitative experience of participants participation in the trial | 6 months | individual semi-structured interviews in a purposive sample of study participants |
| 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- recruitment of participants into the trial | through study completion, an average of 1 year | number of participants recruited per month |
| 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- monthly retention of participants over the trial period | through study completion, an average of 1 year | number of participants retained per month |
| 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-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- safety throughout the trial | 12 months | the number of hospital admissions (non-elective, or elective staying \>24 hours) will be captured |
| feasibility- qualitative experience of participants using the online resource | 3 months | individual semi-structured interviews in a purposive sample from the treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| body mass index over the 12 month trial | baseline, 3 months, 12 months | body mass index at each 3 study visits |
| 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 |
| 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. |
| 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). |
| 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) |
| 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) |
| arterial stiffness over the 12 month trial | at baseline, 3 months and 12 months | arterial stiffness will be measured by pulse wave velocity |
| 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 |
Countries
United Kingdom
Outcome results
None listed