ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study

Study Overview
=================
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.

Official Title
-----------------
ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study. A Feasibility Randomised Controlled Trial.

Conditions
-----------------
Kidney Transplant; Complications, Weight Gain

Intervention / Treatment
-----------------
* Behavioral: ExeRTiOn online resource


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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) | Behavioral: ExeRTiOn online resource<br>* 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.<br>|
| No Intervention: Control group<br>This group will not receive the online resource. They will receive the standard encouragement to follow a healthy diet and perform physical activity during routine transplant follow up appointments. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility- screening of participants | number of participants screened per month, and those unwilling to take part | through study completion, an average of 1 year | 
| Feasibility- recruitment of participants into the trial | number of participants recruited per month | 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 | through study completion, an average of 1 year | 
| feasibility- monthly retention of participants over the trial period | number of participants retained per month | 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 | through study completion, an average of 1 year | 
| feasibility-adherence to ExeRTiOn online resource (intervention group) | aim for 60% completion of sessions | by three months | 
| feasibility- time taken to complete all study visits | the average time taken to complete study visits will be captured | 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 | 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 | 12 months | 
| feasibility- qualitative experience of participants using the online resource | individual semi-structured interviews in a purposive sample from the treatment group | 3 months | 
| feasibility- qualitative experience of participants participation in the trial | individual semi-structured interviews in a purposive sample of study participants | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 3 months and 12 months | 
| body mass index over the 12 month trial | body mass index at each 3 study visits | baseline, 3 months, 12 months | 
| body composition over the 12 month trial | body composition will be measured at each of the 3 study visits | 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 | 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. | 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. | 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). | 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) | 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) | baseline, 3 months, 12 months | 
| arterial stiffness over the 12 month trial | arterial stiffness will be measured by pulse wave velocity | 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 | baseline, 3 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplant, weight gain prevention, behavior change techniques, dietary advice, physical activity advice