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
Adolfo Rubinstein, J Jaime Miranda, Andrea Beratarrechea, Francisco Diez-Canseco, Rebecca Kanter, Laura Gutierrez, Antonio Bernabé-Ortiz,
Vilma Irazola, Ariel Fernandez, Paola Letona, Homero Martínez, Manuel Ramirez-Zea, for the GISMAL group*

Summary
Background Poor diet and physical inactivity strongly affect the growing epidemic of cardiovascular disease worldwide. Lancet Diabetes Endocrinol 2015
Mobile phone-based health interventions (mHealth) have been shown to help promote weight loss and increase physical Published Online
activity and are an attractive approach for health-care systems with limited resources. We aimed to assess whether November 30, 2015
http://dx.doi.org/10.1016/
mHealth with advice for lifestyle improvements would reduce blood pressure, promote weight loss, and improve diet S2213-8587(15)00381-2
quality and physical activity in individuals with prehypertension living in low-resource urban settings in Latin America.
See Online/Comment
http://dx.doi.org/10.1016/
Methods In this parallel-group, randomised controlled trial, we recruited individuals (aged 30–60 years) with systolic S2213-8587(15)00455-6
blood pressure between 120 and 139 mm Hg, diastolic blood pressure between 80 and 89 mm Hg, or both from *Other members listed at end of
health-care centres, workplaces, and community centres in low-resource urban settings in Argentina, Guatemala, and the Article
Peru. Participants were randomly assigned to receive either monthly motivational counselling calls and weekly South American Center of
personalised text messages to their mobile phones about diet quality and physical activity for 12 months, or usual care. Excellence for Cardiovascular
Health (CESCAS), Institute for
Randomisation was stratified by country, and we applied minimisation by sex and age groups. Study personnel collecting Clinical Effectiveness and
and analysing data were masked to group assignment. The primary outcomes were mean between-group differences in Health Policy (IECS),
the changes in systolic and diastolic blood pressure from baseline to 12 months in an intention-to-treat analysis of all Buenos Aires, Argentina
participants who completed assessments at 12 months. Secondary outcome measures were changes in bodyweight, (Prof A Rubinstein PhD,
A Beratarrechea MD,
waist circumference, and self-reported target behaviours from baseline to 12 months. The trial is registered with L Gutierrez MSc, V Irazola MD,
ClinicalTrials.gov, number NCT01295216. A Fernandez MSc); CRONICAS
Center of Excellence in Chronic
Diseases, Universidad Peruana
Findings Between March 1, 2012, and Nov 30, 2012, we randomly assigned 637 participants to receive intervention
Cayetano Heredia, Lima, Peru
(n=316) or usual care (n=321). 266 (84%) participants in the intervention group and 287 (89%) in the control group (J J Miranda PHD,
were assessed at 12 months. The intervention did not affect change in systolic blood pressure (mean net change F Diez-Canseco MSc,
–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) A Bernabé-Ortiz MPH); INCAP
Research Center for the
compared with usual care. However, we noted a significant net reduction in bodyweight (–0·66 kg [–1·24 to –0·07];
Prevention of Chronic Diseases
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 (CIIPEC), Institute of Nutrition
compared with the control group. In a prespecified subanalysis, we found that participants in the intervention group of Central America and
who received more than 75% of the calls (nine or more, from a maximum of 12) had a greater reduction of bodyweight Panama, Guatemala City,
Guatemala (R Kanter PhD,
(–4∙85 [–8∙21 to –1∙48]) and waist circumference (–3∙31 [–5∙95 to –0∙67]) than participants in the control group.
P Letona MSC,
Additionally, participants in the intervention group had an increase in the intake of fruits and vegetables and a M Ramirez-Zea PhD); and RAND
decrease in diets high in sodium, fat, and simple sugars relative to participants in the control group. However, we Corporation, Santa Monica, CA,
found no changes in systolic blood pressure, diasatolic blood pressure, or physical activity in the group of participants USA (H Martínez PhD)
who received more than 75% of the calls compared with the group who received less than 50% of the calls. Correspondence to:
Prof Adolfo Rubinstein, South
American Center of Excellence
Interpretation Our mHealth-based intervention did not result in a change in blood pressure that differed from usual for Cardiovascular Health
care, but was associated with a small reduction in bodyweight and an improvement in some dietary habits. We noted (CESCAS), Institute for Clinical
a dose-response effect, which signals potential opportunities for larger effects from similar interventions in Effectiveness and Health Policy
(IECS), Buenos Aires C1414CPV,
low-resource settings. More research is needed on mHealth, particularly among people who are poor and
Argentina
disproportionally affected by the cardiovascular disease epidemic and who need effective and affordable interventions arubinstein@iecs.org.ar
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 growing epidemic of cardiovascular disease. Worldwide,

Poor diet and physical inactivity account for an estimated cardiovascular disease causes 16∙7 million deaths
10% of the global disability-adjusted life-years.1 The each year, 80% of which occur in low-income and middle-
burden imposed by these risk factors strongly affects the income countries.2 Early interventions to increase the

www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2 1

 Articles
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.
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.3–7 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
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.11–13 Health promotion is
shifting towards new delivery modes of preventive
care, such as mobile phone-based health interventions
(mHealth) that rely on telecommunication and multi-
media technologies, intended to be able to reach a large
population effectively.14–16 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
2 www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2
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.
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.21–24 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.
Methods
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 Hg,
diastolic blood pressure between 80 and 89 mm Hg, or
both, as confirmed by a research assistant. Eligible
participants could not be taking antihypertensive drugs,
had to own a mobile phone for personal use, and were able
to read and understand text messages in Spanish. Pregnant
women, people who were illiterate, and people with
previous diagnosis or treatment of hypertension, diabetes,
or cardiovascular disease were excluded.
To inform the design of the intervention, we used
a qualitative approach to formative research with
community members and patients. We assessed attitudes
to healthy and unhealthy behaviours, mobile phone use,
and text messaging habits in four focus groups per country,
stratified by age (30–44 years and 45–60 years) and sex. A
set of 56 text messages was developed, validated, and
culturally adapted in each country, as described elsewhere;32
these text messages were reviewed by local communicators,
social scientists trained to convey information to lay
persons in each country, to assess the understanding and
adequacy of the message wording and tone. Before the
trial began, we explored the feasibility and acceptability of
the intervention in a 1 month pilot study, which included
45 individuals with prehypertension (16 in Argentina, 12 in
Guatemala, and 17 in Peru).33 The interventions was
delivered as planned with some difficulties related to
obtaining an adequate cellular signal. Both participants
and callers showed good acceptability of the interventions.
The study protocol was independently approved by the
ethics review committees of the Hospital Italiano de
Buenos Aires (Buenos Aires, Argentina), Institute of
Nutrition of Central America and Panama (INCAP; Lima,
Peru), and Universidad Peruana Cayetano Heredia,
Guatemala City, Guatemala, and by the RAND
Corporation, Los Angeles, CA, USA. All study participants
provided written informed consent.
www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2
Articles
Randomisation and masking
All participants were randomly assigned (1:1) to receive
the mHealth-based lifestyle intervention or usual care.
Randomisation was stratified by country, and, to ensure a
balance of known confounding factors between groups,
we applied randomisation by minimisation by sex and
age group (<45 years or ≥45 years). We used an adaptation
of minimPy, a free, open-source program for random
allocation of study participants.34,35 The biased-coin
minimisation method was used to calculate assigned
probabilities; this method allows the selection of a base
probability, which is the probability of assignment for the
group with the lowest allocation ratio. To calculate the
imbalance score, we used the marginal balance method,
which computes the cumulative difference between every
possible pairs of level counts.
After confirmation of eligibility and informed consent,
enrolment was done by research personnel at the sites.
All participants were then randomly assigned to the trail
groups by the Data Management Centre in Buenos Aires,
Argentina. The Data Management Center personnel
were not involved in any other aspects of the trial.
Study personnel responsible for collecting data and
data managers responsible for analysing data were
masked to the intervention assignment. Group allocation
was concealed from study personnel assessing the
outcomes and data managers by generating lists of
participants with masked code numbers. Electronic logs
were used to monitor allocation concealment.
Procedures
During a 3 day training workshop, a trained cognitive
psychologist explained the techniques used in the
intervention programme to the callers in each
participating country.
All study participants received an assessment at baseline
by trained personnel. Assessment consisted of a series of
questionnaires to assess sociodemographic characteristics,
medical history, use of health services, patterns of mobile For the final set of validated
phone use, dietary patterns, alcohol intake, smoking text messages see http://
mhealth.jmir.org/article/
habits, and physical activity. Measurements of readiness
downloadSuppFile/3874/19633
to change lifestyle and behaviours (diet quality and
physical activity) were based on the transtheoretical
model.36 Blood pressure and anthropometric measures
(weight, height, waist circumference, and BMI), were also
recorded at baseline.
After a short introductory call, each participant
received monthly calls to their personal mobile phone by
a trained nutritionist, which continued for up to
12 months. Nutritionists scheduled the calls according
to participant availability and convenience. Each
conversation focused on one of four target behaviours
(reduction of dietary sodium intake, reduction of high-fat
and high-sugar food intake, increase in fruit and
vegetable intake, and promotion of physical activity).
Although alcohol intake and tobacco cessation were
originally included in the protocol, we decided not to
3
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include them among the target behaviours addressed by
the intervention. Alcohol intake was regarded as too
sensitive an issue to be tackled by text messaging
or phone conversation only, without face-to-face
encounters. Our decision to leave out advice on tobacco
cessation advice was based on evidence that unhealthy
diet and physical inactivity are lifestyles more directly
related to blood pressure increase and progression to
hypertension than tobacco smoking,10 and that effective
advice to help people quit smoking would necessitate a
much more intensive intervention than was planned for
in our study. Each participant’s readiness to change a
specified behaviour was assessed by the caller, and the
conversation was tailored to that behaviour. Only one
behaviour change target, agreed to by the participant,
was addressed in each call, but each of the four
behaviours had to be discussed in the first four calls. For
the remaining eight calls, participants could choose to
discuss any of the four target behaviours, a strategy
based on the motivational interviewing principle of
autonomy support. Each call was followed by a weekly
text message with contents related to the target
behaviours and readiness to change that had been
addressed in the previous call. No more than five text
messages were sent each month, and text messages
were not sent during nights or early morning.
The information obtained during the counselling calls
was entered by the nutritionist into a web-based platform
to customise the set of weekly text messages delivered to
the participant in the following month. Finally, an
open-access software program (Frontline SMS version 2)
was used to send the text messages generated by the
web-based platform. The components of the web-based
platform that supported the intervention are shown in
the appendix (p 11). Algorithms used during phone calls
See Online for appendix were based on the transtheoretical model36 and the health
belief model, two psychosocial theories that are widely
used to explain individual behaviour change.37–40
According to the transtheoretical model, behavioural
change occurs in a series of five temporally ordered,
discrete stages (precontemplation, contemplation,
preparation, action, and maintenance),36 whereas in the
health belief model, primary factors that predict why
people will take action to prevent illness are identified
(including perceived susceptibility, perceived severity,
perceived benefits, perceived barriers, cues to action, and
self-efficacy).41 Callers identified the relevant stage in the
transtheoretical model continuum for each participant
and, depending on the stage, introduced appropriate
concepts based on the health belief model to help
participants transition to the next stage. Motivational
interviewing, a non-judgmental, guided, empathetic style
of counselling that has been applied to promote
behavioural change in a wide range of contexts, was also
integrated into the algorithms.42 Text message content
also varied in accordance with the participant‘s readiness
to change. For example, if the participant chose to
4 www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2
address salt and sodium intake and was in a preparation
and action stage according to the transtheoretical model,
she or he would receive a text message recommending
practical suggestions for ways to reduce sodium intake,
such as by seasoning of foods with herbs and spices
instead of salt, gradually reducing the salt content of
foods, reducing the consumption of processed food, such
as hamburgers, hotdogs, and pizza, or preparing lunch at
home.
The web-based platform supported the delivery of
the intervention and stored participants’ baseline
information, an agenda for scheduling monthly calls, a
form to collect information about each participant’s
target behaviour and stage of change, a history of text
messages received during the previous month, and a
customised text message desktop where messages were
generated and tailored to the individual’s stage of change
on target behaviours.
All individuals, irrespective of group assignment,
received a leaflet with written information about the
adoption of healthy lifestyles. In the case of the control
group participants, this leaflet was the only information
they received.
As part of the process assessment of fidelity,
acceptability, and quality of implementation, we included
reach (proportion of the intended target population who
received the intervention), dose (the extent of intervention
components actually implemented), and attrition
(proportion of participants who actively dropped out of
the intervention). At the end of the intervention period,
semi-structured interviews by trained interviewers were
done with a random sample of 120 participants
(40 participants per country) to assess acceptability of the
intervention.
Outcomes
Study outcomes were assessed at baseline (all measures),
at 6 months (blood pressure and weight only), and at
12 months (all measures) after randomisation. The
primary outcome was the mean difference between study
groups in change of systolic and diastolic blood pressure
from baseline to 12 months. Secondary outcomes were
the mean between-group difference in change from
baseline to 12 months in bodyweight, BMI, waist
circumference, and self-reported behavioural factors
such as physical activity and diet quality (dietary sodium
intake, high-fat and high-sugar foods intake, fruit and
vegetable intake).
Blood pressure was measured with the participant in
a seated position after 5 min of rest. Three measurements
were taken at 3 min intervals using a digital blood
pressure monitor (Omron HEM-742INT, Omron
Healthcare, Lake Forest, IL, USA), and the recorded
blood pressure was the mean value of the second and
third measurement. Bodyweight was measured with a
calibrated digital scale with a precision of 100 g (Omron
SC-100/SECA 803). Height was measured without
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shoes to one decimal place with a stadiometer. Waist
circumference was measured with a flexible,
inextensible measuring tape, accurate to 1 mm.
Improvement in diet quality was assessed with a
food-frequency questionnaire (FFQ)43 that was validated
in Spanish for adults in Costa Rica and focused on a
decreased intake of foods high in sodium, simple
sugars, and saturated and trans fats and on an increased
intake of fruits and vegetables, over 1 year. Change in
physical activity was measured in metabolic equivalents
of task (METs) per min per week, by use of the short
version of the International Physical Activity
Questionnaire (IPAQ).44 Since three of the four target
behaviours in our study were related to diet and the
FFQ asked specifically about dietary intake during the
past year, we measured behavioural changes at baseline
and 12 months, but not at 6 months, as originally
planned in the protocol.
Cost-effectiveness analysis and process assessment in
the three countries from a health-system perspective will
be reported elsewhere.
The results of the linear regression model are included
in the appendix. We also did subgroup analyses by sex,
age group, readiness to change, and country. In a
prespecified per-protocol sensitivity analysis, we
analysed primary and secondary outcomes by the
intensity of the intervention actually delivered. We then
did a post-hoc test for trend analysis using χ² test to
assess potential changes in outcomes with increasing
intensity (dose) of the intervention as by country.
The study was planned to follow up participants from
baseline to 18 months. The intervention would take
place during the first 12 months, and 6 months
without intervention would follow until 18 months
post-randomisation. An independent data monitoring
board was to review the primary outcome (systolic and
diastolic blood pressure) at the end of the intervention
period (12 months of follow-up in all participants) to
make a recommendation about whether or not to
continue the follow-up of participants without
intervention until 18 months. Follow-up would be
stopped if differences or (trends towards a difference) in

Statistical analysis
We calculated a target sample size of 212 participants per 2630 participants assessed for eligibility
country (106 participants per group, stratified by sex and
two age groups [30–45 years and 46–60 years]), for a total
1993 ineligible
sample size of 636 participants, assuming a 20% 40 did not know how to read or write
withdrawal rate. With a two-sided α of 0∙05, this target 81 did not live in the city
11 were pregnant
would provide 90% power to detect a mean difference of 243 had hypertension or were in treatment
change in systolic or diastolic blood pressure of at least for hypertension
95 had diabetes or were in treatment for diabetes
5 mm Hg between the intervention and control groups. 78 had heart disease
This sample size would also allow us to detect a difference 44 were moving away
in bodyweight change between groups of 0∙5 kg. 179 did not want to participate
1206 had blood pressure not in prehypertensive range
The primary analysis was an intention-to-treat analysis 16 did not confirm agreement to participate or
of all randomly assigned participants who completed provide informed consent
follow-up assessments at 12 months. Descriptive
analyses included mean and SD for continuous variables
637 randomly assigned
and proportions for categorical variables. As stated in
the protocol, we considered two different approaches for
the primary efficacy analysis. First, we fitted a mixed-
effects model to model average outcome trends at 316 assigned to intervention 321 assigned to control
6 months and 12 months post-randomisation for all
participants, using robust SE in case of any mis-
46 could not be assessed* 45 could not be assessed*
specification of the working correlation structure. For
this analysis, the outcome was modelled in terms of
time effects (6 month and 12 month follow-ups 270 assessed at 6 months 276 assessed at 6 months
compared with baseline), a group effect (intervention vs
control), and group-by-time interaction. Country was
42 lost to follow-up 34 lost to follow-up
included in all models, since the sample was stratified 8 withdrawals
by this variable. We generated different models by
including or excluding individuals who developed
hypertension during the follow-up. Second, we used a
linear regression model of differences between 266 assessed at 12 months 287 assessed at 12 months
and included in and included in
outcomes at 12 month follow-up and baseline to intention-to-treat analysis intention-to-treat analysis
compare participants allocated to the intervention and
control groups. Since both analyses showed similar Figure 1: Trial profile
results, only the mixed-effect model is presented here. *Participants could not be assessed because they did not attend scheduled follow-up meeting at 6 months.

www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2 5

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Role of the funding source

Intervention Control group
group (n=316) (n=321) The funders of the study had no role in the study design,
data collection, data analysis, data interpretation, or writing
Sociodemographic variables
of the report. The corresponding author had full access to
Age, years
all the data in the study and had final responsibility for the
Mean 43·6 (8·4) 43·2 (8·4)
decision to submit for publication.
≤45 years 189 (60%) 192 (60%)
>45 years 127 (40%) 129 (40%)
Results
Male sex 147 (47%) 148 (46%)
Between March 1, 2012, and Nov 30, 2012, we assessed
Marital status
2630 individuals for eligibility and randomly assigned
Single 49 (16%) 54 (17%)
637 participants (212 in Argentina, 213 in Guatemala,
Married or cohabitating partner 232 (73%) 231 (72%) and 212 in Peru), 316 to the intervention group and 321
Separated, divorced, or widow 35 (11%) 36 (11%) the control group (figure 1). 46 participants from the
Household income intervention group and 45 participants from the control
First quintile 29 (9%) 31 (10%) group could not be assessed at 6 months because they
Fifth quintile 71 (23%) 77 (24%) did not attend scheduled meetings despite being
Years of education 11·0 (4·5) 11·3 (4·7) contacted by study personnel. 42 participants in the
Employment status intervention group and 34 participants in the
Employee 129 (41%) 141 (44%) control group were lost to follow-up at 12 months.
Independent worker 94 (30%) 89 (28%) Eight participants (3%) withdrew from the study, all of
Housewife 83 (26%) 76 (24%) whom were assigned to the intervention group
Other 10 (3%) 15 (5%) (four participants declined to give a reason for their
Health insurance coverage 183 (58%) 208 (65%) withdrawal, three participants did not have enough time
Self–reported behavioral variables for participation, and one participant referred to family
Smoking status problems when receiving the calls from the nutritionist).
Never smoker 166 (53%) 162 (51%) Therefore, 266 (84%) participants in the intervention
Former smoker 85 (27%) 102 (32%) group and 287 (89%) participants in the control group
Current smoker 65 (21%) 57 (18%) completed the final assessment visit at 12 months and
Alcohol intake* were included in the primary analysis. Six participants
Never 101 (32%) 112 (35%) from the intervention group and eight participants from
≤1 time per month 133 (42%) 134 (42%) the control group began treatment with anti-hypertensive
2–4 times per month 63 (20%) 62 (19%) drugs during the study period.
2–3 times per week or more 19 (6%) 13 (4%) Demographic and socioeconomic characteristics,
Physical activity lifestyles and behaviours, and physical measures of
METS/min per week 346·5 (66·0– 330·0 (66·0– participants in the intervention group were similar to
824·5) 693·0) those of the control group participants (table 1). The
Low physical activity† 167 (67%) 167 (69%) distribution of the stages of readiness to change of
Daily dietary intake (number of servings) target behaviours (precontemplation, contemplation,
Fruits and vegetables 1·76 (1·34) 1·67 (1·20) preparation, action, and maintenance) is shown in
High-sodium foods 1·23 (1·05) 1·28 (1·21) figure 2. Apart from salt added for cooking, for which
High-fat and high-sugar foods 6·77 (3·12) 6·58 (3·15) most of the participants (54%) said they were not yet
Physical measures ready to change (precontemplative or contemplative),
Bodyweight (kg) 78·0 (15·2) 79·2 (15·1) participants were mostly willing to change (preparation
Systolic blood pressure (mm Hg) 127·2 (5·8) 127·3 (6·2) or action) or actually had changed (maintenance)
Diastolic blood pressure (mm Hg) 77·4 (6·6) 77·5 (6·4) the remaining target behaviours. No differences in
BMI (kg/m²) 30·2 (5·2) 30·8 (5·3)
the distribution of stages were noted between the
Waist circumference (cm) 98·5 (11·8) 99·1 (12·2)
intervention and control groups.
Of the 274 participants in the intervention group who
Data are mean (SD), n (%), or median (IQR). METS=metabolic equivalents of task. completed all the in-person follow-up assessments,
*Alcohol intake and other diet measures were obtained from the Food Frequency
Questionnaire. †Low physical activity refers to less than 600 METS/min/week.
four participants could not be reached by the callers. The
median number of six counselling calls (IQR four to
Table 1: Baseline characteristics eight) were completed. 18 (7%) participants received only
the introductory call, 188 (69%) participants received at
blood pressure between study groups were not found at least half of the scheduled calls, and 111 (41%) participants
the end of the intervention period. received more than 75% of the scheduled calls. Only
This trial is registered with ClinicalTrials.gov, number seven (3%) participants received all 12 scheduled calls. A
NCT01295216. median of 4·2 (IQR 1–14) attempts were made to reach

6 www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2

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participants for each effective call, and the call duration

Precontemplation
ranged from 20 min to 30 min. The distribution of the Physical activity 24%
52% and contemplation
four target behaviours chosen to be addressed by the most days 24% Preparation/action
Maintenance
270 participants of the intervention group in a total of 32%
Intake of five servings
1918 motivational interview calls is shown in the appendix 59%
of fruits and vegetables 9%
(p 12); counselling conversations about reduction of
8%
dietary sodium intake were less common (20%) than for Food with 40%
harmful fats 53%
any of the other behaviours (reduction of high-fat and
high-sugar foods intake [29%], increase of fruit and High-sugar food 6%
35%
vegetable intake [26%], and promotion of physical activity and beverages 60%
[26%]). The number of text messages sent corresponded 10%
High-sodium
to the number of calls, since text messages were sent processed food
35%
56%
out to the participants only as reinforcement after a
scheduled counselling call. A median of 23 text Salt added at 11%
17%
the table
messages were sent per participant during the study 72%
(13–32, maximum 48); 58% of these were reported as Salt added 54%
received by participants. The overall attrition rate in the for cooking 6%
41%
intervention group was 13% and differed between
0 10 20 30 40 50 60 70 80 90 100
countries (24% in Argentina, 10% in Guatemala, and 5%
Proportion of study population (%)
in Peru; χ²=17∧5; p<0∙0001). With respect to the
acceptability of the intervention, most men and women Figure 2: Distribution of stages of change at baseline
(36 [60%] of 60 men vs 39 [65%] of 60 women) found both This figure shows the distribution of the stages of readiness to change of target behaviours (precontemplation,
the phone calls and the text messages to be helpful, contemplation, preparation, action, and maintenance).
mainly because the calls supported the text messages and
vice versa (Kanter R, unpublished). change in the intake of high-sodium foods between
In the primary analysis, we noted no differences in the groups (table 2).
change in systolic or diastolic blood pressure between We detected no change in mean differences in waist
participants in the intervention group and participants in circumference or level of self-reported physical activity
the control group from baseline to 12 months (table 2). between the intervention and control groups (table 2).
We detected no significant decrease in systolic or diastolic To assess the fidelity of implementation, we analysed
blood pressure at 6 months or 12 months. Results from changes in systolic blood pressure, diastolic blood
the longitudinal analysis at 6 months and 12 months pressure, and bodyweight in the intervention group
with repeated measures are shown in the appendix (p 1). according to the dose of the intervention received (table 3).
Blood pressure results were similar when we excluded Of the 12 scheduled calls to be delivered to the
participants who had developed hypertension during the 316 participants in the intervention group, 128 (41%)
trial (systolic blood pressure mean net change difference received fewer than six calls, 77 (24%) received between
–0∙34 [95% CI –2·13 to 1∙45]; p=0∙71; diastolic six and eight calls, and 111 (35%) received nine calls or
blood pressure mean net change difference –0∙02 more. Compared with participants who received less than
[–1∙35 to 1∙31]; p=0∙97). 50% of scheduled calls (ie, fewer than six calls),
The intervention led to a significant net reduction in participants in the intervention group who were able to
bodyweight from baseline to 12 months compared with receive more than 75% of the calls had greater reductions
usual care (table 2). This difference was caused by a small in bodyweight and waist circumference, a greater increase
weight gain in the control group and a small weight loss in the number of daily servings of fruits and vegetables, a
in the intervention group. Whereas participants in the greater decrease in the daily intake of high-sodium foods
intervention group lost an average of 1 kg after 6 months, and a greater decrease in intake of foods high in fats and
which was mostly regained at 12 months, participants in simple sugars between baseline and 12 months (table 3).
the control group showed a trend for weight increase. Subgroup analyses showed that men in the intervention
This difference in bodyweight between groups was group showed a significant reduction in waist
reflected in the greater change in BMI in the intervention circumference from baseline to 12 months compared
group than in the control group (table 2). with men in the control group (–1∙35 [95% CI
We noted some heterogeneity with respect to –2∙48 to –0∙23]; appendix p 2), and participants in the
self-reported dietary outcomes in both groups. Whereas intervention group who were older than 45 years showed
participants in the intervention group reduced the a significant reduction in BMI from baseline to 12 months
number of daily servings of high-fat and high-sugar compared with participants in the control group within
foods from baseline to 12 months, we noted no trend this age group (–0∙33 [–0∙65 to –0∙01]; appendix p 4).
towards increased daily fruit and vegetable intake When analysing the effect of the intervention by country,
compared with the control group and no difference in we noted a significant difference in weight reduction

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Intervention group Control group Mean difference (change relative to baseline)

6 months 12 months 6 months 12 months 6 months† 12 months†
(n=270) (n=266) (n=276) (n=287)
Intervention group vs p value Intervention group vs p value
control group (95% CI) control group (95% CI)
Primary outcomes
Systolic blood pressure 122·3 (10·3) 122·0 (9·9) 123·2 (10·3) 122·3 (11·5) –1·13 (–2·87 to 0·61) 0·31 –0·37 (–2·15 to 1·40) 0·43
(mm Hg)
Diastolic blood pressure 75·2 (7·9) 74·7 (8·2) 76·0 (7·4) 75·0 (8·2) –0·45 (–1·67 to 0·77) 0·44 0·01 (–1·29 to 1·32) 0·99
(mm Hg)
Secondary outcomes
Bodyweight (kg) 77·0 (14·8) 77·8 (15·6) 79·9 (15·2) 79·4 (14·8) –0·31 (–0·79 to 0·17) 0·17 –0·66 (–1·24 to –0·07) 0·04
BMI (kg/m²) 29·9 (5·0) 30·0 (5·1) 31·0 (5·5) 30·9 (5·4) –0·15 (–0·33 to 0·04) 0·10 –0·30 (–0·54 to –0·06) 0·02
Waist circumference (cm) ·· 98·1 (12·0) ·· 99·7 (11·7) ·· ·· –0·64 (–1·62 to 0·35) 0·21
Physical activity ·· 662·0 ·· 602·2 ·· ·· –80·4 (–386·4 to 225·5) 0·61
(METS/min per week) (1116·9) (1319·1)
Daily intake of fruits and ·· 2·18 (1·5) ·· 1·78 (1·3) ·· ·· 0·25 (–0·01 to 0·51) 0·05
vegetables*
Daily intake of ·· 0·75 (0·9) ·· 0·95 (0·9) ·· ·· –0·07 (–0·25 to 0·12) 0·49
high-sodium food*
Daily intake of high-fat ·· 4·59 (2·4) ·· 5·39 (3·0) ·· ·· –0·75 (–1·30 to –0·20) 0·008
and high-sugar foods*

Data are mean (SD), unless otherwise indicated. METS=metabolic equivalents of task. *Calculation is based on the number of servings. †Models were adjusted by country and
baseline information, according to outcome selected.

Table 2: Primary and secondary outcomes at 6 months, and 12 months

<50% (fewer than six calls;
n=128 [41%])
Systolic blood pressure (mm Hg) 0·28 (–2·21 to 2·77)
Diastolic blood pressure (mm Hg) 0·56 (–1·31 to 2·43)
Bodyweight (kg) 1·34 (–2·16 to 4·85)
BMI (kg/m²) –0·96 (–2·18 to 0·26)
Waist circumference (cm) –0·57 (–3·34 to 2·19)
Physical activity (METS/min per week) –72·5 (–347·1 to 202·1)
Daily intake of fruits and vegetables* 0·26 (–0·06 to 0·59)
Daily intake of high-sodium foods* 0·13 (–0·07 to 0·33)
Daily intake of high-fat and high-sugar foods* –0·01 (–0·64 to 0·63)
50–74% (six to eight calls;
n=77 [24%])
–1·67 (–4·42 to 1·09)
–0·37 (–2·44 to 1·70)
–1·28 (–5·16 to 2·60)
–0·34 (–1·69 to 1·01)
–0·86 (–3·90 to 2·18)
58·0 (–276·7 to 392·8)
0·18 (–0·18 to 0·54)
–0·25 (–0·46 to –0·03)
–0·61 (–1·31 to 0·09)
≥75% (nine or more calls;
n=111 [35%])
0·61 (–1·78 to 3·01)
–0·49 (–2·29 to 1·31)
–4·85 (–8·21 to –1·48)
–1·47 (–2·64 to –0·30)
–3·31 (–5·95 to –0·67)
–26·0 (–322·6 to 270·7)
0·66 (0·34 to 0·97)
–0·42 (–0·61 to –0·23)
–1·52 (–2·12 to –0·91)

Data are changes between groups from baseline to 12 months (95% CI). Models were adjusted by country and baseline, information according to outcome selected.
METS=metabolic equivalents of task. *Calculation is based on the number of daily servings.

Table 3: Dose–response to intervention after 12 months

between the intervention and control groups among
participants in Peru (–1∙24 [–2∙16 to –1∙31]), and a
significant difference in the increase in daily intake of
fruit and vegetables among participants in Peru (0∙64
[0∙17 to 1∙11]) and Guatemala (0∙40 [0∙06 to 0∙73];
appendix p 6). No differences in outcomes between
participants in the intervention and control groups were
noted in participants from Argentina. With respect to
states of readiness to change by target behaviour and
primary and secondary outcomes, a decrease in the intake
of high-sugar foods and increase in fruit and vegetables
intakes were noted in participants who were in a state of
preparation or action to change these target behaviours.
We also noted a weight reduction in participants who
were in a state of preparation or action at baseline with
respect to the intake of high-fat and high-sugar foods.
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,

8 www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2


but also an increased prevalence of overweight and
obesity, which put these people at greater cardiometabolic
risk compared with people in the general population.9
Since these individuals can benefit from lifestyle
changes rather than pharmacological treatment, we
designed our intervention to address more proximal
determinants of cardiometabolic health, such as
unhealthy diets and physical inactivity.
Compared with usual care, our 12 month intervention
did not result in a change in blood pressure at the end of
12 months but did lead to a mean reduction in bodyweight
of 0·67 kg. Additionally, we noted a net reduction in the
intake of foods high in fats and simple sugars. No changes
were seen in levels of physical activity. A possible
explanation might be related to the amount of exposure to
different intervention domains defined by the participants
during motivational interviewing, following the principle
of autonomy support. In this respect, reduction of high-fat
and high-sugar foods intake was the target behaviour
most commonly chosen during motivational interviewing
counselling calls.
We believe that the change in weight after 12 months
but not after 6 months, which seems counterintuitive,
might be related to the latency for the intervention in
effecting behavioural changes. Although reduction of
high-fat and high-sugar food intake was the most chosen
target behaviour, participants interested in these topics
were only able to choose it after 5 months of intervention.
Therefore, we speculate that if weight loss was related to
these diet changes, the effect might not have been evident
at 6 months but would have become evident only later
during follow-up.
An important limitation of our study is that as these
findings were not adjusted for multiple comparisons, so
these results should be interpreted with caution. However,
weight reduction was associated with a decrease in
high-fat and high-sugar food intake in the intervention
group compared with usual care, which might support an
intervention effect.
Reductions in bodyweight and waist circumference
and improved diet quality were associated with a higher
dose of the intervention, signalling further opportunities
for larger gains in similar interventions.
We did not find consistent outcome changes in
subgroup analyses by sex, age, country, and state of
change with respect to the four target behaviours.
Individuals from Peru showed a larger weight loss than
participants from any other participating country, and
individuals from Peru and Guatemala increased their
fruit and vegetable intake more than did participants in
Argentina. Compared with participants from Argentina
and Guatemala, individuals from Peru had the highest
BMI values at baseline; hence, the potential for weight
loss could have been greater in Peruvian participants
than in participants from the other two countries.
Likewise, baseline fruit and vegetable intake was lower in
Peru and Guatemala than in Argentina; in fact, the fruit
www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2
Articles
and vegetable intake in the Guatemalan intervention
group at 12 months was lower than the baseline fruit and
vegetable intake in Argentina. Notably, the intervention
did not confer significant changes in any outcomes in
Argentina, where the attrition rate was higher than in the
other two countries, which might be related to cultural
differences between countries and lower acceptability of
the mHealth-based strategy in Argentina.
Of particular interest was the absence of a relation
between participant’s readiness to change some types
of behaviour and actual reported changes of those
behaviours, which might need further exploration.
Investigators of a systematic review identified some
evidence that mHealth might be useful to support
self-management of chronic disorders.45 Furthermore,
evidence exists to suggest that text messages might be an
effective channel of communication to promote
behaviours conducive to weight loss in adults who are
overweight or obese.46–50 However, results of some
studies27,51 showed no difference in weight loss from the
use of personally weight-relevant text messages or
customised smartphone applications in individuals who
were overweight or obese. With respect to the role of
mHealth to encourage lifestyle modification and reduce
blood pressure, the evidence is even more sparse.
Liu and colleagues52 reviewed 13 studies assessing the
efficacy of internet-based interventions to complement
the clinical management of blood pressure or hyper-
tension and reported a significant 3·8 mm Hg reduction
of systolic blood pressure and 2·1 mm Hg reduction in
diastolic blood pressure. Three of the studies included text
messages as supplemental intervention, the application of
which was seen not to improve systolic and diastolic
blood pressure compared with results from studies that
only included internet-based intervention. Although
internet-based interventions reduced blood pressure, the
high attrition rate, which ranged from 6% to 47% across
the studies included in the systematic review, was an
important challenge. Another threat to the implementation
of these interventions in low-income and middle-income
countries is access to internet, particularly in low-income
settings. Since our participants had prehypertension
rather than hypertension, their low systolic and diastolic
blood pressure values might have prevented a blood
pressure response to the intervention. However, the
absence of a difference in mean blood pressure at
12 months compared with baseline between the
intervention and control groups mirrored the absence of
differences in reduction of dietary salt intake between
groups. Moreover, when we analysed the target behaviours
chosen by the intervention participants to be addressed in
the motivational interviews, we noted a lower proportion
of counselling calls related to dietary sodium reduction
compared with the other three behaviours addressed in
the calls. This factor might help to account for the absence
of a difference in changes in blood pressure between the
two groups.
9
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This study has some other limitations. First, although
results of previous studies have shown phone calls and
text messages to be effective in the provision of health
care, the intervention in our study could have been
hampered by its low-to-moderate reach and dose.
Furthermore, the absence of an effect of the intervention
on blood pressure might be more of an indicator of
implementation failure due to poor fidelity and
acceptability rather than of low effectiveness of the
intervention. In fact, our results showed that the higher
the intensity of the intervention, the greater the change in
the main and secondary outcomes, implying that an
improvement in the fidelity of the intervention could have
had led to a larger effect. As the fidelity of the intervention
was lower than anticipated, we cannot make a conclusion
about the appropriate intervention dose, whether by
phone call or text message, necessary to achieve positive
behavioural changes. Nevertheless, in view of the
substantial constraints and anticipated difficulties in the
implementation of this technology-based intervention in
low-resource settings in Latin America, such as different
patterns of mobile phone use and an inability of some
poor people to read and interpret text messages, as well as
gaps in culture and communication between professional
callers and less well educated participants, our results
although modest, are encouraging.
Another limitation is that, after 12 months, our results
showed that participants who had received the
intervention had a mean weight regain of about 800 g
relative to the mean bodyweight in this group at 6 months.
Since readiness to change behaviour was only assessed at
baseline, we could not test whether this relapse was
related to a behaviour change of participants between 6
and 12 months. Furthermore, some secondary outcomes,
such as dietary measures, might have been affected by an
acquiescence bias since they were self-reported. This bias
might have been particularly prominent in the
intervention arm, thereby increasing the differences in
outcome measure relative to the control group. However,
the questionnaires were administered by independent
assessors who were not aware of the assignment of the
individuals, which should reduce the likelihood of such a
bias affecting our results.
Another potential concern is that the intervention might
have triggered more interactions with health-care providers,
which could have affected the achievement of behavioural
changes in these participants. However, this effect could be
seen as a desired outcome for this group, if such
interactions do have a positive effect on health behaviours.
Finally, although it was not possible to mask participants to
the assignment due to the nature of the intervention,
research personnel assigned to the intervention component
were different from the personnel who did the assessment.
Additionally, since the mHealth intervention did not
involve in-person contacts, the chance that the participants
in the control group could have being exposed to the
intervention (contamination) seems to be low.
10 www.thelancet.com/diabetes-endocrinology Published online November 30, 2015 http://dx.doi.org/10.1016/S2213-8587(15)00381-2
One of our main concerns was whether an intervention
based only on mHealth-based coaching reinforced by
individualised text messages without a personal contact
with a health provider would be intensive enough to
promote even a small change in health-related lifestyles
and behaviours, in view of the fact that the evidence to
support the effects of mobile phone-based interventions
on diet and physical activity remains unclear.28 Although
our results suggest that phone calls and text messages
can be used to reduce bodyweight and improve diet
quality, this type of intervention could be more useful as
a booster of face-to-face behavioural interventions than
as a standalone intervention strategy, as shown in
another study53 in which weight loss was greater
(–3·4 kg) than in our trial; however, the intervention in
that study was also more intense than in our study, with
in-person visits and daily, rather than weekly, tailored
text messages for 6 months.
mHealth is a promising technology-based preventive
health strategy in low-income and middle-income
countries (including countries in Latin America), where
health systems are often weak and under-resourced.54
However, many questions with respect to the
effectiveness of such interventions remain, including
which strategies work better (eg, mHealth alone or as
a complement of face-to-face contacts with health
providers), which mobile functions (voice calls, text
messages, video, or smartphone applications) are most
effective, and whether the effectiveness of interventions
is determined by the sociodemographic characteristics
of populations, settings, culture, and context, including
the characteristics of local health-care systems. More
research is needed to address these issues, particularly
in populations of poor people who are disproportionally
affected by the epidemic of cardiovascular disease and
need effective, cost-effective, acceptable, and affordable
interventions to help bridge the equity gap in the
management of cardiometabolic risk factors.
Contributors
AR, JJM, MR-Z, and HM conceived the aims and design of the study and
wrote the proposal. PL designed and supervised the behavioural
intervention. FD-C designed and validated the text messages. AB-O
coordinated the pilot feasibility study. AF participated in the programming
of text messages and the design of the web-based platform. LG coordinated
the data management. AB-O and VI did the statistical analysis. All authors
analysed and interpreted the results. AR drafted the report and all authors
contributed to the revision of the report. AR is guarantor of the study.
Members of the GISMAL group
All authors are members of GISMAL (Grupo de Investigación en Salud
Móvil en América Latina). Additional non-author members of the group
are Adrían Alasino (FunPRECAL, Mar del Plata, Prov. de Buenos Aires.
Argentina), Berneth Nuris Budiel Moscoso (Universidad Peruana Cayetano
Heredia, Lima, Peru), Carolina Carrara (Hospital Italiano de Buenos Aires,
Buenos Aires, Argentina), Jackelyn Espinoza Surichaqui (Universidad
Peruana Cayetano Heredia, Lima, Peru), Gimena Giardini (Hospital
Italiano de Buenos Aires, Buenos Aires, Argentina), Jesica Guevara
(Institute of Nutrition of Central America and Panama, Guatemala City,
Guatemala), Analí Morales Juárez (Institute of Nutrition of Central
America and Panama, Guatemala City, Guatemala), Lorena Lázaro Cuesta
(FunPRECAL, Mar del Plata, Prov. de Buenos Aires. Argentina),

Dalia Lewitan (Institute for Clinical Effectiveness and Health Policy,
Buenos Aires, Argentina), Lita Palomares Estrada (Universidad Peruana
Cayetano Heredia, Lima, Peru), Carla Martínez Ramírez (Universidad
Peruana Cayetano Heredia, Lima, Peru), Gloria Robles de la Cruz
(Universidad Peruana Cayetano Heredia, Lima, Peru), Julissa Salguero
(Institute of Nutrition of Central America and Panama, Guatemala City,
Guatemala), Juan Carlos Saravia Drago (Universidad Peruana Cayetano
Heredia, Lima, Peru), María Urtasún (Institute for Clinical Effectiveness
and Health Policy, Buenos Aires, Argentina), and
José Alfredo Zavala Loayza (Universidad Peruana Cayetano Heredia, Lima,
Peru).
Declaration of interests
We declare no competing interests.
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