utrition and physical activity intervention for families with familial hypercholesterolaemia

Not Applicable

Completed

• Conditions: Familial hypercholesterolaemia; Nutritional, Metabolic, Endocrine; Pure hypercholesterolaemia

• Registration Number: ISRCTN24880714
• Lead Sponsor: niversity of Bristol

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32266080 protocol (added 09/04/2020) 2020 Results article in http://dx.doi.org/10.1136/bmjopen-2020-044200 (added 14/07/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-07
• Study Completion: 2020-04-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of the intervention and research methods, assessed through measurement of:<br>1. Recruitment to the trial <br>2. Attendance at research visits<br>3. Retention rate<br>4. Adherence to research procedure methods including data collection <br>5. Acceptability of the dietary and PA intervention <br>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 Outcome Measures

Name	Time	Method
1. Blood metabolomic (primarily lipidomic) markers , measured through analysis of blood samples collected pre and post intervention <br>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<br>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 <br>4. Health related quality of life (QOL), measured using an age-appropriate QOL questionnaire pre and post intervention<br>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