1. Introduction
−0.93–2.83, obesity, high-cardiovascular-risk, weight reduction
OBESITY, HEART, CARDIOVASCULAR DISEASE
Objective: To evaluate the effectiveness and cost-effectiveness of offering the combined lifestyle programme “Healthy Heart”, addressing overweight, diet, physical activity, smoking and alcohol, to improve lifestyle behaviour and reduce cardiovascular risk. Design: A practice-based non-randomised stepped-wedge cluster trial with two-year follow-up. Outcomes were obtained via questionnaires and routine care data. A cost–utility analysis was performed. During the intervention period, “Healthy Heart” was offered during regular cardiovascular risk management consultations in primary care in The Hague, The Netherlands. The period prior to the intervention period served as the control period. Results: In total, 511 participants (control) and 276 (intervention) with a high cardiovascular risk were included (overall mean ± SD age 65.0 ± 9.6; women: 56%). During the intervention period, 40 persons (15%) participated in the Healthy Heart programme. Adjusted outcomes did not differ between the control and intervention period after 3–6 months and 12–24 months. Intervention versus control (95% CI) 3–6 months: weight: β −0.5 (−1.08–0.05); SBP β 0.15 (−2.70–2.99); LDL-cholesterol β 0.07 (−0.22–0.35); HDL-cholesterol β −0.03 (−0.10–0.05); physical activity β 38 (−97–171); diet β 0.95 (−0.93–2.83); alcohol OR 0.81 (0.44–1.49); quit smoking OR 2.54 (0.45–14.24). Results were similar for 12–24 months. Mean QALYs and mean costs of cardiovascular care were comparable over the full study period (mean difference (95% CI) QALYs: −0.10 (−0.20; 0.002); costs: EUR 106 (−80; 293)). Conclusions: For both the shorter (3–6 months) and longer term (12–24 months), offering the Healthy Heart programme to high-cardiovascular-risk patients did not improve their lifestyle behaviour nor cardiovascular risk and was not cost-effective on a population level.Cardiovascular diseases cause a high burden of morbidity and rising health care expenditures [Lifestyle changes as part of a cardiovascular risk management approach can be initiated at the level of primary care, for example by the general practitioner (GP), but may further be guided by other dedicated lifestyle professionals. This process could potentially be supported by health care professionals following the needs and possibilities of the patient. When available, GPs can refer to combined lifestyle intervention programmes, provided by lifestyle coaches who help patients to improve multiple lifestyle factors. Structured examples of such programmes are suggested to reduce cardiometabolic risk [Several combined lifestyle interventions in The Netherlands have been recognised as being effective for a 1–3 kg weight reduction in people with obesity in the short term (1 year) and longer term (1.5–2 years) [Initiation of a healthy lifestyle is often considered to be time-consuming and influenced by the motivation and commitment of both patients and care providers [Therefore, in this study we aimed to examine the (cost-)effectiveness on a population level of offering referral to a combined lifestyle programme—“Healthy Heart”—as part of cardiovascular risk management in primary care in an urbanised, socio-economically diverse area. We examined the effect of offering the programme on weight, systolic blood pressure (SBP), cholesterol levels, diet quality, physical activity, smoking and alcohol consumption in the target population. Furthermore, we examined goalsetting on lifestyle behaviour and self-reported achievement of goals. To examine the cost–benefit of implementing the programme we performed a cost–utility analysis. With this study, we provide new insights on the effects of offering a lifestyle intervention in a real-life primary care setting.