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

King's College Hospital NHS Trust

Status: Completed

Conditions: Weight Gain; Kidney Transplant; Complications

Treatments: Behavioral: ExeRTiOn online resource

Study type: Interventional

Funder types: Other

Identifiers

NCT03996551

KCH-ExeRTiOn2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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)

Treatment:

Behavioral: ExeRTiOn online resource

Control group

No Intervention group

Description:

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.