An intervention study to improve food shopping and prevent cardiovascular disease among patients in primary care: the PC SHOP trial
- Conditions
- Adults with high LDL cholesterolNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN14279335
- Lead Sponsor
- niversity of Oxford
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 113
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in SFA intake is measured using the 2 x 24h dietary recalls using the Web-Q instrument at baseline and 3 months (follow up).
- Secondary Outcome Measures
Name Time Method