ISRCTN14279335已完成未知
Primary Care Shopping Intervention for Cardiovascular Disease Prevention
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 113
研究概览
简要总结
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30992293 (added 16/04/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33151934/ (added 12/03/2021) 2021 qualitative results in https://pubmed.ncbi.nlm.nih.gov/33807150/ (added 06/04/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria, as of 08/02/2019:
- •Main study:
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or Female, aged 18 years or above
- •3. With confirmed LDL cholesterol above 3 mmol/L at recruitment
- •4. Express a desire for support to improve the nutritional quality of their diet to reduce their CVD risk
- •5. Primarily responsible for household shopping (e.g. complete at least half of their household shopping)
- •6. Shops mainly at Tesco (e.g. at least once/week instore and/or online) using a Tesco’s storecard. They need to have had a Tesco’s storecard for at least 3 months before recruitment
- •7. Computer literate
- •Screening criteria:
- •1. Age =18 years with a blood test in the GP records which indicate LDL-cholesterol >3.5 mmol/L or total cholesterol >5.5 mmol/L in the past 24 months
- •2. Who will likely benefit from a lower SFA diet with no pre-existing conditions that warrant exclusion.
- •Qualitative study:
- •1. Participated in intervention 2 arm (brief advice plus shopping advice) of the PC-SHOP study
- •2. Willing to be interviewed
- •Previous participant inclusion criteria:
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or Female, aged 18 years or above
- •3. With confirmed LDL cholesterol above 3 mmol/L at recruitment
- •4. Express a desire for support to improve the nutritional quality of their diet to reduce their CVD risk
- •5. Primarily responsible for household shopping (e.g. complete at least half of their household shopping)
- •6. Shops mainly at Tesco (e.g. at least once/week instore and/or online) using a Tesco’s storecard. They need to have had a Tesco’s storecard for at least 3 months before recruitment
- •7. Computer literate
- •Screening criteria:
- •1. Age =18 years with a blood test in the GP records which indicate LDL-cholesterol >3.5 mmol/L or total cholesterol >5.5 mmol/L in the past 24 months
- •2. Who will likely benefit from a lower SFA diet with no pre-existing conditions that warrant exclusion.
排除标准
- •Current exclusion criteria, as of 19/03/2018:
- •1. Unable to read and understand the instructions provided in English
- •2. Pregnant, or planning to become pregnant during the course of the study
- •3. Planned or likely changes to cholesterol-lowering medication
- •4. 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
- •5. Familial hyperlipidaemia
- •6. Currently or recently (within the last 3 months) participating in another intervention study which likely affects the outcomes measured in this study.
- •7. Patients that the GP judges not able to meet the demands of the study or unlikely to adhere to study procedures as stated in the protocol
- •Previous exclusion criteria:
- •1. Unable to read and understand the instructions provided in English
- •2. Pregnant, or planning to become pregnant during the course of the study
- •3. Planned or likely changes to cholesterol-lowering medication
- •4. 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
- •5. Familial hyperlipidaemia
- •6. Currently or recently (within the last 3 months) participating in another study
- •7. Patients that the GP judges not able to meet the demands of the study or unlikely to adhere to study procedures as stated in the protocol
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