Randomised controlled feasibility trial of a complex behavioural intervention to reduce salt intake among people with high blood pressure

niversity of Oxford0 sites50 target enrollmentApril 5, 2017

Overview

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31604477 protocol (added 14/10/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34673535/ (added 25/02/2022)

Registry

who.int

Start Date

April 5, 2017

End Date

July 5, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 15/02/2019:
•1\. Participants’ most recent systolic blood pressure reading in the past 2 years is above 130 mmHg if they are currently taking anti\-hypertensive medication or above 140 mmHg (if non\-medicated)
•2\. If on pharmacological treatment for hypertension, participant has been prescribed a stable dose for at least the past 6 weeks.
•3\. Participant is willing and able to give informed consent for participation in the study
•4\. Male or female, aged between 18 and 80 years
•5\. English speaking
•6\. Who regularly shop in a supermarket (excluding online supermarkets), spending at least £25 at least once a fortnight
•7\. Own a smartphone (android or iOS) and express interest in using an app for healthy eating
•8\. Who express a desire for support to improve the nutritional quality of their diet to reduce their CVD risk
•Previous inclusion criteria:

•Current exclusion criteria as of 15/02/2019:
•1\. Already on a clinician supervised diet or a restricted diet
•2\. Unwilling to make dietary changes
•3\. Are currently using or have used the Foodswitch or Saltswitch apps previously
•4\. Unable to read and understand the instructions provided in English
•5\. Participants with secondary, previous accelerated or malignant hypertension as defined by read code
•6\. Currently being assessed for diagnosis of hypertension
•7\. Currently on any medication that may lead to hyponatraemia or fluid retention
•8\. Existing or recent cardiovascular conditions: heart attack or stroke within the last 3 months, heart failure of grade II New York Heart Association and more severe, or prolonged QT syndrome, angina, arrhythmia or atrial fibrillation
•9\. Currently participating in another study