Clinical trial NCT03996551: ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study
Official title: ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study. A Feasibility Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Weight Gain
Keywords: kidney transplant
weight gain prevention
behavior change techniques
dietary advice
physical activity advice
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Kidney Research U.K.
First posted: 2019-06-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility- screening of participants
timeFrame: through study completion, an average of 1 year
measure: Feasibility- recruitment of participants into the trial
timeFrame: through study completion, an average of 1 year
measure: Feasibility- proportion of participants willing to be randomized
timeFrame: through study completion, an average of 1 year
measure: feasibility- monthly retention of participants over the trial period
timeFrame: through study completion, an average of 1 year
measure: feasibility- total retention of participants over the trial period
timeFrame: through study completion, an average of 1 year
measure: feasibility-adherence to ExeRTiOn online resource (intervention group)
timeFrame: by three months
measure: feasibility- time taken to complete all study visits
timeFrame: through study completion, an average of 1 year
measure: feasibility- adherence to study visits throughout the trial
timeFrame: through study completion, an average of 1 year
measure: feasibility- safety throughout the trial
timeFrame: 12 months
measure: feasibility- qualitative experience of participants using the online resource
timeFrame: 3 months
measure: feasibility- qualitative experience of participants participation in the trial
timeFrame: 6 months
Secondary outcomes:
measure: change in body weight in kilograms over the trial
timeFrame: baseline, 3 months and 12 months
measure: body mass index over the 12 month trial
timeFrame: baseline, 3 months, 12 months
measure: body composition over the 12 month trial
timeFrame: baseline, 3 months, 12 months
measure: quality of life (self-reported) over the 12 month trial
timeFrame: baseline, 3 months, 12 months
measure: self reported self-efficacy for nutrition scale over the 12 month trial
timeFrame: baseline, 3 months, 12 months
measure: self reported self-efficacy for physical exercise scale over the 12 month trial
timeFrame: baseline, 3 months, 12 months
measure: Total score self reported fatigue via the Chalder Fatigue Questionnaire over the 12 months
timeFrame: baseline, 3 months, 12 months
measure: Physical fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months
timeFrame: baseline, 3 months, 12 months
measure: Mental fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months
timeFrame: baseline, 3 months, 12 months
measure: arterial stiffness over the 12 month trial
timeFrame: at baseline, 3 months and 12 months
measure: physical function over the 12 month trial
timeFrame: baseline, 3 months, 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
state: UK
city: London
country: United Kingdom
facility: King's College Hospital
state: UK
Study officials:
References:
citation: 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.