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

Sponsor

King's College Hospital NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03996551

Collaborator

Kidney Research U.K. (Other)

Enrollment

Locations

Arms

21.3

Actual Duration (Months)

8.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant; Complications Weight Gain	Behavioral: ExeRTiOn online resource	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 20, 2019

Actual Primary Completion Date :

Mar 22, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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 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.
No Intervention: Control group 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.

Arm

Intervention/Treatment

Experimental: Intervention Group

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

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.

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

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
feasibility- qualitative experience of participants participation in the trial [6 months]
individual semi-structured interviews in a purposive sample of study participants

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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