This review examines the effectiveness of health promotion interventions that aim to reduce more than one major cardiovascular risk factor (multiple risk factor intervention) for the primary prevention of cardiovascular disease in low- and middle-income countries (LMICs). Such risk factors are overweight/obesity, high blood pressure, smoking, too much bad cholesterol or low physical activity levels.
Evidence from high-income countries indicates that multiple risk factor intervention programmes do not result in reductions in cardiovascular disease (CVD) events. Given the increasing incidence of CVDs and lower CVD health awareness in LMICs it is possible that such programmes may have beneficial effects. One vital element in improving this situation is a comprehensive and relevant evidence base, which would equip LMICs to take informed action. The components of health promotion activities may include the following: (a) dietary advice to promote healthy eating habits; (b) reducing harmful alcohol intake; (c) advice on the cessation of cigarette smoking; (d) advice on increasing daily physical activity; and (e) reducing body weight.
We performed a thorough search of the medical literature up to June 2014. We identified 13 trials that recruited 7310 participants. Two trials recruited healthy participants and the other 11 trials recruited people at varying risk of CVD, such as participants with known hypertension("high blood pressure") and type 2 diabetes, and randomly assigned them to either a multiple risk factor intervention or to no intervention. The trials were conducted between 2001 and 2010, and published between 2004 and 2012. Three trials were conducted in Turkey. Two trials each were conducted in China and Mexico. One trial recruited participants from both China and Nigeria. The other trials were conducted in Brazil, India, Pakistan, Romania and Jordan. The content of the interventions varied across the trials; most of the trials included dietary advice and advice on physical activity. The trials follow-up the participants between six months to 30 months (average follow-up period was 13.3 months).
We found that evidence for effects on cardiovascular disease events was scarce, with only one trial reporting these. None of the included trials reported deaths from any cause. Multiple risk factors interventions may lower systolic blood pressure, diastolic blood pressure, body mass index and waist circumference. We found no difference for eating more fruit and vegetables, rates of smoking cessation, measure of blood glucose sugar was for the past two to three months, fasting blood sugar, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and total cholesterol. None of the included trials reported on harms.
Quality of the evidence
Overall, the studies included in this review were at some risk of bias and there was variation between the results of the studies when we analysed the data. Our findings should be treated with some caution.
Due to the limited evidence currently available, we can draw no conclusions as to the effectiveness of multiple risk factor interventions on combined CVD events and mortality. There is some evidence that multiple risk factor interventions may lower blood pressure levels, body mass index and waist circumference in populations in LMIC settings at high risk of hypertension and diabetes. There was considerable heterogeneity between the trials, the trials were small, and at some risk of bias. Larger studies with longer follow-up periods are required to confirm whether multiple risk factor interventions lead to reduced CVD events and mortality in LMIC settings.
In many low- and middle-income countries (LMICs) morbidity and mortality associated with cardiovascular diseases (CVDs) have grown exponentially over recent years. It is estimated that about 80% of CVD deaths occur in LMICs. People in LMICs are more exposed to cardiovascular risk factors such as tobacco, and often do not have access to effective and equitable healthcare services (including early detection services). Evidence from high-income countries indicates that multiple risk factor intervention programmes do not result in reductions in CVD events. Given the increasing incidence of CVDs and lower CVD health awareness in LMICs it is possible that such programmes may have beneficial effects.
To determine the effectiveness of multiple risk factor interventions (with or without pharmacological treatment) aimed at modifying major cardiovascular risk factors for the primary prevention of CVD in LMICs.
We searched (from inception to 27 June 2014) the Cochrane Library (CENTRAL, HTA, DARE, EED), MEDLINE, EMBASE, Global Health and three other databases on 27 June 2014. We also searched two clinical trial registers and conducted reference checking to identify additional studies. We applied no language limits.
We included randomised controlled trials (RCTs) of health promotion interventions to achieve behaviour change (i.e. smoking cessation, dietary advice, increasing activity levels) with or without pharmacological treatments, which aim to alter more than one cardiovascular risk factor (i.e. diet, reduce blood pressure, smoking, total blood cholesterol or increase physical activity) of at least six months duration of follow-up conducted in LMICs.
Two authors independently assessed trial eligibility and risk of bias, and extracted data. We combined dichotomous data using risk ratios (RRs) and continuous data using mean differences (MDs), and presented all results with a 95% confidence interval (CI). The primary outcome was combined fatal and non-fatal cardiovascular disease events.
Thirteen trials met the inclusion criteria and are included in the review. All studies had at least one domain with unclear risk of bias. Some studies were at high risk of bias for random sequence generation (two trials), allocation concealment (two trials), blinding of outcome assessors (one trial) and incomplete outcome data (one trial). Duration and content of multiple risk factor interventions varied across the trials. Two trials recruited healthy participants and the other 11 trials recruited people with varying risks of CVD, such as participants with known hypertension and type 2 diabetes. Only one study reported CVD outcomes and multiple risk factor interventions did not reduce the incidence of cardiovascular events (RR 0.57, 95% CI 0.11 to 3.07, 232 participants, low-quality evidence); the result is imprecise (a wide confidence interval and small sample size) and makes it difficult to draw a reliable conclusion. None of the included trials reported all-cause mortality. The pooled effect indicated a reduction in systolic blood pressure (MD -6.72 mmHg, 95% CI -9.82 to -3.61, I² = 91%, 4868 participants, low-quality evidence), diastolic blood pressure (MD -4.40 mmHg, 95% CI -6.47 to -2.34, I² = 92%, 4701 participants, low-quality evidence), body mass index (MD -0.76 kg/m², 95% CI -1.29 to -0.22, I² = 80%, 2984 participants, low-quality evidence) and waist circumference (MD -3.31, 95% CI -4.77 to -1.86, I² = 55%, 393 participants, moderate-quality evidence) in favour of multiple risk factor interventions, but there was substantial heterogeneity. There was insufficient evidence to determine the effect of these interventions on consumption of fruit or vegetables, smoking cessation, glycated haemoglobin, fasting blood sugar, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and total cholesterol. None of the included trials reported on adverse events.