Adults with high LDL cholesterol Nutritional, Metabolic, Endocrine Adults with high LDL cholesterol
Conditions
Interventions
Current interventions, as of 08/02/2019:
In the main trial participants are randomly allocated to either a control or intervention group.
Intervention 1: Brief advice s
or with mono- and polyunsaturated fat sources (e.g. change from butter to low-fat vegetable spread).
Intervention 2: Brief advice session and shopping report
In additio
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures, as of 08/02/2019: 1. Changes in SFA from total purchases and the proportion of food items with low SFA (e.g. products with =1.5 grams of SFA per 100 grams of the product) is measured using purchasing records obtained from the supermarket at baseline and 3 months (follow up). 2. Changes in LDL-cholesterol, HDL-cholesterol, total cholesterol and triglycerides is measured using blood samples taken at baseline and 3 months (follow up). 3. Changes in energy intake, total fat, total sugars, fibre and salt; and high SFA food groups (updated 19/03/2018) is measured using 2x24h dietary recalls using the Web-Q instrument at baseline and 3 months (follow up). 4. Changes in energy density, total fat, sugar, fibre and salt from purchases is measured using purchasing records obtained from the supermarket at baseline and 3 months (follow up). 5. Changes in systolic and diastolic blood pressure is measured using an electronic blood pressure monitors at baseline and 3 months (follow up). 6. Changes (absolute (kg) and relative (%)) in body weight is measured using a calibrated electronic platform scale at baseline and 3 months (follow up). 7. Feasibility and process measures: 7.1. Willingness of participants to take part in the study and be randomised is measured using recruitment rates at baseline. 7.2. Programme attendance and retention is measured using follow up and completion rates at 3 months. 7.3. Acceptability of the intervention for participants and health professionals; uptake of knowledge, motivation and swaps accepted is measured using non validated questionnaires at baseline and 3 months (follow up). 8. Issues related to food purchasing behaviours, including knowledge, perceived barriers, facilitators and actions, contextual influences, and value of the healthcar | — |
Countries
United Kingdom
Outcome results
None listed