ISRCTN20910962已完成未知
Randomised controlled feasibility trial of a complex behavioural intervention to reduce salt intake among people with high blood pressure
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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