Articles
Effectiveness of an mHealth intervention to improve the cardiometabolic profile of people with prehypertension in low-resource urban settings in Latin America: a randomised controlled trial

https://doi.org/10.1016/S2213-8587(15)00381-2Get rights and content

Summary

Background

Poor diet and physical inactivity strongly affect the growing epidemic of cardiovascular disease worldwide. Mobile phone-based health interventions (mHealth) have been shown to help promote weight loss and increase physical activity and are an attractive approach for health-care systems with limited resources. We aimed to assess whether mHealth with advice for lifestyle improvements would reduce blood pressure, promote weight loss, and improve diet quality and physical activity in individuals with prehypertension living in low-resource urban settings in Latin America.

Methods

In this parallel-group, randomised controlled trial, we recruited individuals (aged 30–60 years) with systolic blood pressure between 120 and 139 mm Hg, diastolic blood pressure between 80 and 89 mm Hg, or both from health-care centres, workplaces, and community centres in low-resource urban settings in Argentina, Guatemala, and Peru. Participants were randomly assigned to receive either monthly motivational counselling calls and weekly personalised text messages to their mobile phones about diet quality and physical activity for 12 months, or usual care. Randomisation was stratified by country, and we applied minimisation by sex and age groups. Study personnel collecting and analysing data were masked to group assignment. The primary outcomes were mean between-group differences in the changes in systolic and diastolic blood pressure from baseline to 12 months in an intention-to-treat analysis of all participants who completed assessments at 12 months. Secondary outcome measures were changes in bodyweight, waist circumference, and self-reported target behaviours from baseline to 12 months. The trial is registered with ClinicalTrials.gov, number NCT01295216.

Findings

Between March 1, 2012, and Nov 30, 2012, we randomly assigned 637 participants to receive intervention (n=316) or usual care (n=321). 266 (84%) participants in the intervention group and 287 (89%) in the control group were assessed at 12 months. The intervention did not affect change in systolic blood pressure (mean net change −0·37 mm Hg [95% CI −2·15 to 1·40]; p=0·43) or diastolic blood pressure (0·01 mm Hg [–1·29 to 1·32]; p=0·99) compared with usual care. However, we noted a significant net reduction in bodyweight (−0·66 kg [–1·24 to −0·07]; p=0·04) and intake of high-fat and high-sugar foods (−0·75 [–1·30 to −0·20]; p=0·008) in the intervention group compared with the control group. In a prespecified subanalysis, we found that participants in the intervention group who received more than 75% of the calls (nine or more, from a maximum of 12) had a greater reduction of bodyweight (−4·85 [–8·21 to −1·48]) and waist circumference (−3·31 [–5·95 to −0·67]) than participants in the control group. Additionally, participants in the intervention group had an increase in the intake of fruits and vegetables and a decrease in diets high in sodium, fat, and simple sugars relative to participants in the control group. However, we found no changes in systolic blood pressure, diasatolic blood pressure, or physical activity in the group of participants who received more than 75% of the calls compared with the group who received less than 50% of the calls.

Interpretation

Our mHealth-based intervention did not result in a change in blood pressure that differed from usual care, but was associated with a small reduction in bodyweight and an improvement in some dietary habits. We noted a dose-response effect, which signals potential opportunities for larger effects from similar interventions in low-resource settings. More research is needed on mHealth, particularly among people who are poor and disproportionally affected by the cardiovascular disease epidemic and who need effective and affordable interventions to help bridge the equity gap in the management of cardiometabolic risk factors.

Funding

National Heart, Lung, and Blood Institute (US National Institutes of Health) and the Medtronic Foundation.

Introduction

Poor diet and physical inactivity account for an estimated 10% of the global disability-adjusted life-years.1 The burden imposed by these risk factors strongly affects the growing epidemic of cardiovascular disease. Worldwide, cardiovascular disease causes 16·7 million deaths each year, 80% of which occur in low-income and middle-income countries.2 Early interventions to increase the practice of healthy lifestyles in individuals who are at high risk of cardiovascular disease can reduce blood pressure, excess bodyweight, and glycaemic impairment and prevent or delay the onset of type 2 diabetes and hypertension.3, 4, 5, 6, 7 Prehypertension (defined as systolic blood pressure of 120–139 mm Hg or diastolic blood pressure of 80–89 mm Hg) is associated with an increased probability of cardiovascular events, with a progression rate to hypertension of 10–20% per year.8, 9

Research in context

Evidence before this study

Early interventions to increase the adoption of healthy lifestyles in high-risk individuals can reduce blood pressure, excess bodyweight, and glycaemia, helping to prevent type 2 diabetes and hypertension or delay their onset. Evidence-based guidelines advocate for specific lifestyle modifications in populations at high risk of cardiovascular disease. However, few high-quality trials of lifestyle interventions aimed at reducing cardiovascular disease risk have been done in countries in Latin America or other low-income and middle-income countries worldwide, despite robust evidence in support of the effectiveness of these measures. With the rapid growth of mobile phone use in developing countries, mobile phone-based health interventions (mHealth) are emerging as a useful approach to bolster health-care systems with an overburdened workforce, limited financial resources, and an increasing prevalence of chronic diseases. This type of intervention has been shown to promote behavioural changes, leading to effects such as weight loss and increased physical activity, but the evidence is mixed, especially for long-term effects, and very few studies have been done in low-income and middle-income countries or low-resource settings.

Added value of this study

To our knowledge, this is the first randomised controlled trial to assess an mHealth intervention that aims to promote healthy lifestyle behaviours in individuals in Latin America who are at high risk of developing cardiovascular disease. 12 months of intervention did not result in a change in blood pressure (the primary outcome measure), but did lead to a modest reduction in bodyweight and an improvement in diet quality.

Implications of all the available evidence

Our results, although modest, are encouraging and fill an important research gap on the effect of mobile phone-based interventions on behavioural risk factors for the prevention of cardiovascular disease in low-income and middle-income countries. However, more research is needed, particularly in populations from low-resource settings in low-income and middle-income countries, which are disproportionally affected by the epidemic of chronic diseases.

Evidence-based guidelines advocate for specific lifestyle modifications in populations with high risk of cardiovascular disease.10 However, few trials to test lifestyle interventions for the reduction of cardiovascular disease risk have been done in Latin America or in low-income and middle-income countries, despite robust evidence of their effectiveness.11, 12, 13 Health promotion is shifting towards new delivery modes of preventive care, such as mobile phone-based health interventions (mHealth) that rely on telecommunication and multimedia technologies, intended to be able to reach a large population effectively.14, 15, 16 Yet, evidence in favour of mHealth for lifestyle modification is inconclusive17 and is mostly restricted to trials done in high-income countries.18, 19

With the rapid rise in mobile phone use in low-income and middle-income countries, mHealth could become a useful way to address several health-care system constraints in these countries, such as the small and overburdened health-care workforce, limited financial resources, and an increasing prevalence of chronic diseases. In view of these constraints, the extension of health care to difficult-to-reach populations is challenging.20 Strategies that depend on either mobile phone calls or text messaging have been shown to improve patient–provider communication, encourage behaviour change, and assist in chronic disease management.21, 22, 23, 24 Interventions based on phone calls and text messages have also been shown to promote weight loss and increase physical activity.21, 25 In a systematic review26 use of text messages for preventive health care was found to improve health status and health behaviour, but the evidence is mixed, especially with respect to the long-term effectiveness of such interventions. Interestingly, results of a study27 of tailored text messages to prevent the onset of type 2 diabetes in patients with glucose impairment in India showed a significant reduction in incidence after 2 years of follow-up. However, almost all of the 75 trials that have assessed the use of mHealth to improve disease management or change health behaviours were done in high-income countries.28 In fact, in one systematic review,24 only nine of the trials included in the analysis were from low-income or middle-income countries, and in another review29 a few high-quality studies in less developed countries were identified, mostly from middle-income countries.

Chronic disorders and their risk factors are now the major causes of death, disability, and illness in Latin America.1 In 2004, cardiovascular disease was the cause of about 35% of all deaths and 68% of the total disease burden.30 Health systems in most Latin American countries perform poorly on measures of effectiveness and quality of care for patients with cardiovascular disease, and primary care systems in the region do not usually have preventive programmes for people who are at high risk of cardiovascular disease.31

In this study, we aimed to investigate whether mHealth that included monthly counselling phone calls and customised text messages containing advice for lifestyle modification could reduce blood pressure and prevent progression to hypertension, promote weight loss, and improve diet quality and physical activity in adults with prehypertension living in low-resource urban settings in Argentina, Guatemala, and Peru.

Section snippets

Study design and participants

In this multicentre, parallel-group, randomised controlled trial, we recruited adult men and women with prehypertension from health-care centres, workplaces, and community centres in poor urban settings in Buenos Aires, Argentina (one primary care clinic and two workplaces), Guatemala City, Guatemala (one primary care clinic and one workplace), and Lima, Peru (one primary care clinic and one hospital). Eligible participants (aged 30–60 years) had systolic blood pressure between 120 and 139 mm

Results

Between March 1, 2012, and Nov 30, 2012, we assessed 2630 individuals for eligibility and randomly assigned 637 participants (212 in Argentina, 213 in Guatemala, and 212 in Peru), 316 to the intervention group and 321 the control group (figure 1). 46 participants from the intervention group and 45 participants from the control group could not be assessed at 6 months because they did not attend scheduled meetings despite being contacted by study personnel. 42 participants in the intervention

Discussion

To our knowledge, this is the first randomised controlled trial to assess a mobile phone-based intervention to promote healthier lifestyle behaviours in individuals at high risk of cardiovascular disease in Latin America, and one of the first such trials to be done in low-income and middle-income countries. We included participants who had blood pressure in the prehypertensive range because such individuals not only have increased blood pressure, but also an increased prevalence of overweight

References (54)

  • AV Chobanian et al.

    The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report

    JAMA

    (2003)
  • S Ebrahim et al.

    Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease

    BMJ

    (1997)
  • PA James et al.

    2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8)

    JAMA

    (2014)
  • WC Knowler et al.

    Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin

    N Eng J Med

    (2002)
  • 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study

    Lancet

    (2009)
  • J Hsia et al.

    Prehypertension and cardiovascular disease risk in the Women's Health Initiative

    Circulation

    (2007)
  • JS Lin et al.

    Behavioural counseling to promote a healthy lifestyle in persons with cardiovascular risk factors: a systematic review for the US Preventive Services Task Force

    Ann Intern Med

    (2014)
  • A Siqueira-Catania et al.

    Cardiometabolic risk reduction through lifestyle intervention programs in the Brazilian public health system

    Diabetol Metab Syndr

    (2013)
  • CC Mazzaro et al.

    Dietary interventions and blood pressure in Latin America—systematic review and meta-analysis

    Arq Bras Cardio

    (2014)
  • A Ramachandran et al.

    The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1)

    Diabetologia

    (2006)
  • L Deborah

    M-health and health promotion: the digital cyborg and surveillance society

    Soc Theory Health

    (2012)
  • R Istepanian et al.

    M-Health: emerging mobile health systems

    (2006)
  • Germanakos P, Mourlas C, Samaras G. A mobile agent approach for ubiquitous and personalized eHealth information...
  • LF Kohl et al.

    Online prevention aimed at lifestyle behaviours: a systematic review of reviews

    J Med Internet Res

    (2013)
  • TL Webb et al.

    Using the internet to promote health behaviour change: a systematic review and meta-analysis of the impact of theoretical basis, use of behaviour change techniques, and mode of delivery on efficacy

    J Med Internet Res

    (2010)
  • P Mechael et al.

    Barriers and gaps affecting mHealth in low and middle income countries: policy white paper

  • S Krishna et al.

    Healthcare via cell phones: a systematic review

    Telemed J E Health

    (2009)
  • Cited by (0)

    Other members listed at end of the Article

    View full text