A randomised controlled trial on the effects of an individual tailored lifestyle intervention to minimise the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH)

Cardiovascular disease (CVD) has the highest burden in disability adjusted life
years (DALYs) in the Netherlands5. FH is characterized by an elevated risk of
developing cardiovascular disease. Worldwide, no in-depth intervention is known
on the promotion of a healthy lifestyle within this risk population. Until now,
attention has mainly been focussed on the effectiveness of pharmaceutical
interventions instead of achieving a relevant lifestyle improvement4.
Given the high a priori CVD risk of people with FH and proven effects of
lifestyle interventions in other high-risk groups the absolute risk reduction
that can be gained is much larger than in the general population.

The study aims at examining the effect of an individual tailored lifestyle
intervention to reduce the cardiovascular disease risk in people with FH.
Secundary, the study aims at promoting a healthy lifestyle (no smoking, proper
nutritional pattern, sufficient physical activity, adherence to medication) in
people with FH.

The study is a randomised controlled trial. 400 people who are notificated of
their positive FH-status, are randomly assigned to either the intervention
(n=200) or control group (n=200).

The intervention consists of counselling a health lifestyle which is a
combination of web-based counselling, face-to-face counselling (1 session),
brochures and telephone booster sessions (3 sessions). Face-to-face counselling
will take place at the participant*s home. The control group will not receive
this intervention.

The intervention (including all intervention components) will cost
approximately 135 minutes, as calculated in section E2 of this form. We expect
the participants, who are just notificated of their FH status, have a higher
intrinsic motivation to change their lifestyle. Thereby, the type of behaviour
to change is dependent on their personal situation (tailored counselling) and
that*s why we expect the participants to be motivated to cooperate.

Measurements and questionnaires will also take time (approximately 130 minutes,
see section E2 of this form) but do not pose a risk to the participants.
Benefits for the participants include gained knowledge about behavioural change
with regard to the risk of premature CVD. Additionally, increased physical
activity has a beneficial effect on psychological wellbeing.