Familial hypercholesterolaemia Nutritional, Metabolic, Endocrine Pure hypercholesterolaemia
Conditions
Interventions
Family units will be randomly assigned to one of two groups to receive either usual care (control group) or the 12-week nutrition and PA intervention (intervention group). 1:1 randomisation of family
11-16 year olds= 25g/day and 30g/day for =17 year olds)
6. 2g of stanol/sterols
The PA component of the intervention aims to help family units achieve the recommended population PA guidelines which a
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 10-18 years and their parent (=18 years) 2. Genetically confirmed clinical diagnosis of heterozygous FH 3. Receive their care from the paediatric or adult lipid clinics at Bristol University Hospitals or Royal United Hospitals Bath NHS Trust Foundations
Exclusion criteria
Exclusion criteria: 1. Pregnant female patients, or those planning pregnancy 2. Patients who are unable to give informed consent 3. Parents or carers of young people with FH who themselves do not have FH 4. Patients with a diagnosis of homozygous FH 5. Patients not established on statin therapy for at least 3 months prior to recruitment to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the intervention and research methods, assessed through measurement of: 1. Recruitment to the trial 2. Attendance at research visits 3. Retention rate 4. Adherence to research procedure methods including data collection 5. Acceptability of the dietary and PA intervention These will all be measured at the end of the study. Data from adult and child participants will be analysed separately. Recruitment, attendance and retention rates will be descriptively described. Adherence to research procedures will be measured through the calculating the number of participants who completed each research procedure. Acceptability of the dietary and PA intervention will be measured through analysis of the qualitative data collected through qualitative interviews conducted with a sub-sample of the participants at their final research visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood metabolomic (primarily lipidomic) markers , measured through analysis of blood samples collected pre and post intervention 2. Energy content and nutrient composition (macro- and micro-nutrient) of dietary intake, measured using online 24hr recall tool over 4 days at home by each participant pre and post intervention 3. PA levels (minutes of moderate and vigorous PA) and sedentary activity (minutes of sedentary time), measured by Actigraph and ActivPal monitors worn by participants over 7 days 1 week pre and post intervention 4. Health related quality of life (QOL), measured using an age-appropriate QOL questionnaire pre and post intervention These will be measured at research contacts 2 and 3. Research contact 2 will be carried out at baseline and research contact 3 approximately 12 weeks after this | — |
Countries
England, United Kingdom
Outcome results
None listed