NCT03996551

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

June 18, 2019

Last Update Submit

August 19, 2021

Conditions

Kidney Transplant; ComplicationsWeight Gain

Keywords

kidney transplantweight gain preventionbehavior change techniquesdietary advicephysical activity advice

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (11)

  • change in body weight in kilograms over the trial

    baseline, 3 months and 12 months

  • body mass index over the 12 month trial

    baseline, 3 months, 12 months

  • body composition over the 12 month trial

    baseline, 3 months, 12 months

  • quality of life (self-reported) over the 12 month trial

    baseline, 3 months, 12 months

  • self reported self-efficacy for nutrition scale over the 12 month trial

    baseline, 3 months, 12 months

  • +6 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

ExeRTiOn online resourceBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guy's and St Thomas' Hospital

London, UK, SE1 9RT, United Kingdom

Location

King's College Hospital

London, UK, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35677553DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 24, 2019

Study Start

September 20, 2019

Primary Completion

March 22, 2021

Study Completion

June 30, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

GB(2)