No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial

Abstract

BackgroundPeople with Familial Hypercholesterolemia (FH) may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia. This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids (low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol (TC) and triglycerides), systolic blood pressure, glucose, body mass index (BMI) and waist circumference in people with FH.MethodsAdults with FH (n = 340), recruited from a Dutch cascade screening program, were randomly assigned to either a control group or an intervention group. The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling. The control group received care as usual. Lipids, systolic blood pressure, glucose, BMI, and waist circumference were measured at baseline and after 12 months. Regression analyses were conducted to examine differences between both groups.ResultsAfter 12 months, no significant between-group differences of cardiovascular disease (CVD) risk indicators were observed. LDL-C levels had decreased in both the intervention and control group. This difference between intervention and control group was not statistically significant.ConclusionsThis project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH. The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies.Trial registrationNTR1899 at ww.trialregister.nl

An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

“…Mean difference IV, random, 95% CI (mmHg) Mean difference IV, random, 95% CI (mmHg) Weight Bove 181 Broekhuizen 184 Claes 180 Dekkers Phone 179 Dekkers Web 179 Nolan 2011 182 Nolan 2012 183 Sone 178 …”

“…Mean difference IV, random, 95% CI (mmol/l) Mean difference IV, random, 95% CI (mmol/l) Weight Bove 181 Broekhuizen 184 Claes 180 Dekkers Phone 179 Dekkers Web 179 Nolan 2012 183 Wister 48 Heterogeneity: τ 2 = 0.01; χ 2 = 10.92, df = 6 (p = 0.09); I 2 = 45% Test for overall effect: z = 1. Meta-analyses and a summary of other modifiable CVD risk factors measured in the included trials was not performed due to lack of consistent inclusion in overall CVD risk score calculations, or the inability to convert reported outcomes into single measures for comparison and analysis.…”

“…Mean difference IV, random, 95% CI (mmol/l) Mean difference IV, random, 95% CI (mmol/l) Weight Bove 181 Broekhuizen 184 Sone 178 Wister 48 Heterogeneity: τ 2 = 0.00; χ 2 = 5.92, df = 3 (p = 0.12); I 2 = 49% Test for overall effect: z = 0. 25 Some of these were inadequately analysed or reported, for example, not reporting 95% CIs or making between-group comparisons.…”

Can Multiple Lifestyle Behaviours Be Improved in People with Familial Hypercholesterolemia? Results of a Parallel Randomised Controlled Trial

“…In the PRO-FIT project, we developed an individually tailored lifestyle intervention aimed at a CVD risk reduction in individuals with FH. At first, we investigated the efficacy of the intervention on biological CVD risk indicators: lipids (LDL-C, HDL-C, TC and triglycerides), systolic blood pressure, glucose, body mass index (BMI) and waist circumference [19]. In this paper, we report the efficacy on smoking, physical activity, dietary intake and compliance to statin therapy.…”

Familial hypercholesterolemia in children and adolescents: A clinical perspective

“…39 However, the degree of LDL lowering in the research setting and in clinical practice is modest, and lifestyle modification trials in adults with FH appear to show little benefit. 40 There are no published studies comparing different dietary approaches in FH, for example, low glycemic load vs low saturated fat, with regard to LDL lowering. Available data and clinical experience suggest following a low sat and/or trans-fat approach in this high-risk patient population is reasonable until and unless new data become available, although additional dietary approaches may be required if the patient has other CVD risk factors such as adiposity or high TG levels.…”