Hypertension Circulatory System Hypertensive diseases
Conditions
Interventions
Participants will be randomised to one of two groups using computer generated block randomisation.
Intervention: Participants will receive a behavioural intervention consisting of one
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 1. Participants’ most recent blood pressure reading in the past 2 years is 140/90 mmHg or higher (taken in clinic, with or without subsequent ambulatory blood pressure monitoring daytime average or home blood pressure monitoring average blood pressure of 135/85 mmHg or higher) 2. Not currently taking hypertension medication 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) 8. Who express a desire for support to improve the nutritional quality of their diet to reduce their CVD risk
Exclusion criteria
Exclusion 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 10. Patients that the GP judges not able to meet the demands of the study or unlikely to comply with study procedures as stated in the protocol 11. They are planning on going away from home for more than 2 consecutive weeks during the 6 week intervention period Previous exclusion criteria: 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. Currently on blood pressure lowering medication 6. Currently on any medication that may lead to hyponatraemia or fluid retention 7. 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. 8. Currently participating in another study (including follow-up) 9. Patients that the GP judges not able to meet the demands of the study or unlikely to comply with study procedures as stated in the protocol 10. They are planning on going away from home (holiday or other) for more than 4 consecutive days during the 6 week intervention period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Study follow -up rate will be measured as the percentage of participants, in each arm of the study who attend the follow-up session within within 4 weeks from the end of the intervention period. 2. Intervention fidelity will be measured, on completion of delivery of all intervention advice sessions, as the mean percentage of pre-specified components of the intervention advice session which are delivered by the practice nurse(s). The fidelity with which the intervention was implemented will be tested by asking nurses to audio-record the consultation which is then compared against a checklist of the components required by the protocol. 3. Intervention usage (app usage) will be measured as the number of participants who use the app to scan products on at least one occasion by the end of month one of the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Salt content of purchased foods is measured as salt in g/100g of total product weight, assessed through scanning of purchased product bar-codes and linking to a food and nutrient information database during a baseline period of two weeks before the intervention and over the intervention period 2. Sodium intake is measured using a 24 hour urinary sodium test, at baseline and at the 6 week follow up appointment 3. Blood pressure is measured using an electronic BP monitor at baseline and at the 6 week follow up | — |
Countries
England, United Kingdom
Outcome results
None listed