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

August 19, 2021 updated by: King's College Hospital NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility- screening of participants
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
number of participants recruited per month
through study completion, an average of 1 year
Feasibility- proportion of participants willing to be randomized
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
number of participants retained per month
through study completion, an average of 1 year
feasibility- total retention of participants over the trial period
Time Frame: through study completion, an average of 1 year
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)
Time Frame: by three months
aim for 60% completion of sessions
by three months
feasibility- time taken to complete all study visits
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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
Time Frame: 12 months
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
Time Frame: 3 months
individual semi-structured interviews in a purposive sample from the treatment group
3 months
feasibility- qualitative experience of participants participation in the trial
Time Frame: 6 months
individual semi-structured interviews in a purposive sample of study participants
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in body weight in kilograms over the trial
Time Frame: baseline, 3 months and 12 months
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
Time Frame: baseline, 3 months, 12 months
body mass index at each 3 study visits
baseline, 3 months, 12 months
body composition over the 12 month trial
Time Frame: baseline, 3 months, 12 months
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
Time Frame: baseline, 3 months, 12 months
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
Time Frame: 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.
baseline, 3 months, 12 months
self reported self-efficacy for physical exercise scale over the 12 month trial
Time Frame: 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.
baseline, 3 months, 12 months
Total score self reported fatigue via the Chalder Fatigue Questionnaire over the 12 months
Time Frame: 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).
baseline, 3 months, 12 months
Physical fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months
Time Frame: baseline, 3 months, 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
Time Frame: baseline, 3 months, 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
Time Frame: at baseline, 3 months and 12 months
arterial stiffness will be measured by pulse wave velocity
at baseline, 3 months and 12 months
physical function over the 12 month trial
Time Frame: baseline, 3 months, 12 months
physical function will be assessed by the six minute walk test at each timepoint
baseline, 3 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College Hospital NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kidney Research U.K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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