Reducing cardiovascular disease risk among families with familial hypercholesterolaemia by improving diet and physical activity: a randomised controlled feasibility trial

Objective Familial hypercholesterolaemia (FH) elevates low-density lipoprotein cholesterol (LDL-C) and increases cardiovascular disease (CVD) risk. This study aimed to provide evidence for the feasibility of conducting a randomised controlled trial to evaluate the efficacy of an intervention designed to improve diet and physical activity in families with FH.

Design A parallel, randomised, wait-list controlled, feasibility pilot trial.

Setting Three outpatient lipid clinics in the UK.

Participants Families comprised of children (10-18 years) and their parent with genetically diagnosed FH.

Intervention Families were randomised to either 12-week usual-care or intervention. The behavioral change intervention aimed to improve dietary, physical activity and sedentary behaviours. It was delivered to families by dietitians initially via a single face-to face session and then by four telephone or email follow-up sessions.

Outcome measures Feasibility was assessed via measures related to recruitment, retention, and intervention fidelity. Post-intervention qualitative interviews were conducted to explore intervention acceptability. Behavioural (dietary intake, physical activity and sedentary time) and clinical (blood pressure, body composition and blood lipids) outcomes were collected at baseline and endpoint assessments to evaluate the intervention’s potential benefit.

Results Twenty-one families (38% of those approached) were recruited, comprised of 22 children and 17 adults with FH, and 97% of families completed the study. The intervention was implemented with high fidelity and the qualitative data revealed it was well accepted. Between group differences at the endpoint assessment were indicative of the intervention’s potential for improving diet in children and adults. Evidence for potential benefits upon physical activity and sedentary behaviours were less apparent. However, the intervention was associated with improvements in several CVD risk factors including LDL-C, with a within group mean decrease of 8% (children) and 10% (adults).

Conclusions The study’s recruitment, retention, acceptability, and potential efficacy supports the development of a definitive trial, subject to identified refinements.