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

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

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).

Study Overview

• Status: Completed
• Conditions: Weight Gain; Kidney Transplant; Complications
• Intervention / Treatment: Behavioral: ExeRTiOn online resource

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom, SE1 9RT
      • Guy's and St Thomas' Hospital
    • London, UK, United Kingdom, SE5 9RS
      • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: Kidney Research U.K.

Publications and helpful links

General Publications

• Castle EM, Dijk G, Asgari E, Shah S, Phillips R, Greenwood J, Bramham K, Chilcot J, Greenwood SA. The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial. Front Nutr. 2022 May 23;9:887580. doi: 10.3389/fnut.2022.887580. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2019
• Primary Completion (ACTUAL): March 22, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (ACTUAL): June 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: kidney transplant; weight gain prevention; behavior change techniques; dietary advice; physical activity advice
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain
• Other Study ID Numbers: KCH-ExeRTiOn2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The research team plans to publish the results in a journal publication. They will include anoymized raw data in the supplementary material

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No