Nutrition and physical activity intervention for families with FH
Research type
Research Study
Full title
Feasibility of a family-based nutrition and physical activity intervention in young people with familial hypercholesterolaemia: A mixed methods study
IRAS ID
239039
Contact name
Julian Hamilton-Shield
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Familial hypercholesterolaemia (FH) is a common genetic disorder, characterised by raised levels of low density lipoprotein cholesterol (LDL-C) from birth. The lifelong exposure to these high LDL-C levels puts individuals at an increased risk of premature cardiovascular disease (CVD) and associated mortality.
Lifelong treatment with medication is recommended for all patients. This has reduced the incidence of CVD in people with FH, however they still remain at higher risk than the general population. Lifestyle factors can also influence LDL-C levels and other CVD risk factors and therefore lifestyle advice is considered importance for people with FH. However, there is limited evidence to support the effectiveness of the current nutritional and physical activity (PA) guidelines upon LDL-C levels in people with FH. The need for trials to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended.This study is designed to investigate if a family-based intervention based upon the current NICE nutrition and PA recommendations for people with FH can be implemented and accepted by young people and their affected parent.
Families will be randomised to receive a 12-week nutrition and PA intervention or to a control group who will receive usual care, which is medication only. Nutrition intake, PA levels and blood cholesterol levels will be measured at baseline and at 12-week follow up.
The primary objective of this study is to investigate the feasibility of the intervention and research methods which will be assessed through measurement of recruitment to the study, attendance at study visits and acceptability of the intervention- determined via interviews. Secondary objectives include measuring blood cholesterol levels, dietary intakes and PA levels before the intervention and at 12-week follow up and comparing any changes between the control and intervention groups.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0121
Date of REC Opinion
8 Jun 2018
REC opinion
Further Information Favourable Opinion