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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03996551
Other study ID # KCH-ExeRTiOn2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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