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

Weight Gain Clinical Trial

— ExeRTiOn2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996551
• Other study ID #: KCH-ExeRTiOn2
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Kidney Transplant; Complications
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' Hospital	London	UK
United Kingdom	King's College Hospital	London	UK

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Kidney Research U.K.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility- screening of participants	number of participants screened per month, and those unwilling to take part	through study completion, an average of 1 year
Primary	Feasibility- recruitment of participants into the trial	number of participants recruited per month	through study completion, an average of 1 year
Primary	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
Primary	feasibility- monthly retention of participants over the trial period	number of participants retained per month	through study completion, an average of 1 year
Primary	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
Primary	feasibility-adherence to ExeRTiOn online resource (intervention group)	aim for 60% completion of sessions	by three months
Primary	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
Primary	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
Primary	feasibility- safety throughout the trial	the number of hospital admissions (non-elective, or elective staying >24 hours) will be captured	12 months
Primary	feasibility- qualitative experience of participants using the online resource	individual semi-structured interviews in a purposive sample from the treatment group	3 months
Primary	feasibility- qualitative experience of participants participation in the trial	individual semi-structured interviews in a purposive sample of study participants	6 months
Secondary	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
Secondary	body mass index over the 12 month trial	body mass index at each 3 study visits	baseline, 3 months, 12 months
Secondary	body composition over the 12 month trial	body composition will be measured at each of the 3 study visits	baseline, 3 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	arterial stiffness over the 12 month trial	arterial stiffness will be measured by pulse wave velocity	at baseline, 3 months and 12 months
Secondary	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