The wEight Management in Renal Transplant Online Study (ExeRTiOn)

NCT03699059 | Completed DMC

• 3 other identifiers: KCH-EXERTION STUDY241928KCH18-085
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this project is to create an online weight management tool (Physical activity, weight management and cognitive behavioral therapy) to prevent significant weight gain following kidney transplantation. Designing the online interactive weight management resource for kidney transplant patients will involve patient and health care professional input through Qualitative methodology such as 'Think-Aloud' interviews and one-to-one semi-structured interviews. This online resource will be called "exertion" and will be created by the research team, with technical support from the Software Company (SPIKA). Results from this study will refine the resource, and lead to a study application for a randomized controlled feasibility trial where we plan to test the "exertion" online application. Therefore this project has potential to influence clinical practice for kidney transplant recipients. It will allow patients, who may not have routine access to physio or dietetic input to address weight gain with support. A study flow chart summarizing the project can be found below.

Conditions

Kidney Transplant; Complications; Obesity; Physical Activity; Weight Gain; Health Behavior

Keywords

Kidney transplant; Weight gain; Physical activity; Weight management

Outcome Measures

Primary Outcomes (1)

• Patient experience and learning using the "ExeRTiOn" online resource

  Patient experience and learning using the "ExeRTiOn" online resource determined by qualitative interview

  day 1

Secondary Outcomes (12)

• Transplant health care professional experience and knowledge reviewing the online resource

  day 1

• Any difficulties/ barriers to participating in the study

  day 1

• Any difficulties/ barriers to using the "ExeRTiOn" resource

  day 1

• Components of the "ExeRTiOn" resource that are helpful/ unhelpful

  day 1

• Weakness of the "ExeRTiOn" resource

  day 1

Study Arms (2)

Health Care Professionals

OTHER

A purposeful sample of 5 HCP's from the transplant team will test the online intervention and be interviewed using qualitative methods. This data will be analysed and used to plan a second study (feasibility RCT).

Other: ExeRTiOn

Kidney Transplant Patients

OTHER

A purposeful sample of 10 kidney transplant patients will test the online intervention and be interviewed using qualitative methods. This data will be analysed and used to plan a second study (feasibility RCT).

Other: ExeRTiOn

Interventions

ExeRTiOn OTHER

REHAB-online is an online weight gain prevention tool comprising of physical activity advice, dietetic advice, self-monitoring and tracking and behavioural change techniques. This resource is specific to kidney transplant patients and has been created by the research steering group including patient representation. During this study participants (both HCPs and patients) will have a one-off study visit to test and evaluate the online intervention.

Health Care Professionals; Kidney Transplant Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (18years+)
• Male or female
• Written informed consent
• \< 3 months post kidney transplant
• access to internet connected computer, smart-phone or tablet
• A Body Mass Index (BMI) greater than or equal to 18.5 (healthy range)

You may not qualify if:

• pregnancy
• Unstable medical conditions such as; angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis/ pericarditis, cardiac arrhythmia, co-morbid catabolic conditions, psychiatric illness.
• Participated in a structured exercise or physical activity intervention in the last three months.
• BMI of less than 18.5 (classified as underweight)
• significant cognitive impairment preventing them from engaging with online interactive material
• Eligibility criteria for the Transplant Health Care Professionals (n=5)
• A nephrologist, kidney doctor, nurse or member of the multi-disciplinary team who actively work with kidney transplant patients at King's College Hospital
• Adult above 18 years of age
• Able to provide written consent
• Access to Internet connected computer, smart-phone or tablet.
• Pregnancy
• Unstable medical conditions such as angina, uncontrolled hypertension or diabetes, congestive cardiac failure, active myocarditis, cardiac arrhythmia, co-morbid catabolic condition, psychiatric illness.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Kidney Research U.K.: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Weight Gain; Health Behavior

Interventions

Physical Exertion

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ellen Castle

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No blinding. Purposive sampling of the 15 subjects- 5 HCP, 10 kidney transplant patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A small study creating a kidney transplant specific online weight gain prevention tool with qualitative data from 15 participants (5 transplant MDT members and 10 kidney transplant recipients)

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: October 9, 2018
• Study Start: May 31, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: within 6-12 months of study completion
• Access Criteria: data will be available as supplementary material through online publication. For example Plos one.

Locations

GB (1)