Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings

Mobile Health to Prevent Progression of Pre-hypertension in Latin American Urban Settings

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01295216

Enrollment

637

Registered

2011-02-14

Start date

2011-09-30

Completion date

2013-12-31

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Prehypertension

Keywords

prehypertension, blood pressure, mobile technology, Latin America, behavioral change, healthy lifestyles, mHealth

Brief summary

Nearly half of the adult population in Latin American urban settings has abnormally high blood pressure. Although half of these subjects with high blood pressure are still in the pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high (10-20% per year), according to studies done in other settings. The main objective of this proposal is to evaluate the effectiveness of an affordable and sustainable primary health care intervention to reduce blood pressure and prevent progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile health) support for 12 months (intervention group) will have lower blood pressure compared to individuals who receive the usual primary health care (control group); and that pre-hypertensive subjects will maintain lower blood pressure six months after receiving mHealth support. The investigators will determine the effects of an intervention using mHealth technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants. The intervention also aims to help participants become better informed, motivated, and encouraged to practice self-management of their own health; to improve patient satisfaction levels; provide tailored targeted interventions; and to improve patient-provider relationships. The proposal is designed as a proof-of-concept intervention in three Latin American countries that encompass a wide range of environments and health care settings. A total of 212 subjects (30-60 years old) per country will be recruited in primary health clinics and randomized to study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12 during the intervention, and six months after the end of the intervention. The investigators will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation of the intervention.

Interventions

BEHAVIORALMobile technology to promote lifestyle modification

Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range * No current anti-hypertensive medication * Own a personal cellular phone

Exclusion criteria

* Previous diagnosis/treatment hypertension * Illiteracy * Another household member already in the study

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Baseline, 6, 12, and 18 months	A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time

Secondary

Measure	Time frame
Change From Baseline in Food Intake at 12 Months	Baseline and 12 months
Change From Baseline in Body Weight at 12 Months	Baseline and 12 months
Change From Baseline in Body Mass Index at 12 Months	Baseline and 12 months
Change From Baseline in Waist Circumference at 12 Months	Baseline and 12 months
Change From Baseline in Physical Activity at 12 Months	Baseline and 12 months

Countries

Argentina, Guatemala, Peru

Participant flow

Participants by arm

Arm	Count
Intervention Pre-hypertensive subjects who receive mHealth support for 12 months Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants	316
Control Individuals who receive the usual primary health care	321
Total	637

Baseline characteristics

Characteristic	Total	Intervention	Control
Age, Continuous	43.4 Years STANDARD_DEVIATION 8.4	43.6 Years STANDARD_DEVIATION 8.4	43.2 Years STANDARD_DEVIATION 8.4
Region of Enrollment Argentina	212 participants	104 participants	108 participants
Region of Enrollment Guatemala	213 participants	105 participants	108 participants
Region of Enrollment Peru	212 participants	107 participants	105 participants
Sex: Female, Male Female	342 Participants	169 Participants	173 Participants
Sex: Female, Male Male	295 Participants	147 Participants	148 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 316	0 / 321
serious Total, serious adverse events	0 / 316	0 / 321

Outcome results

Primary

Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months

A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time

Time frame: Baseline, 6, 12, and 18 months

Arm	Measure	Group	Value (MEAN)
Intervention	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Systolic blood pressure, 12 months	-5.23 mmHg
Intervention	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Diastolic blood pressure, 12 months	-2.34 mmHg
Intervention	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Systolic blood pressure, 6 months	-5.13 mmHg
Intervention	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Diastolic blood pressure, 6 months	-1.82 mmHg
Intervention	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Systolic blood pressure, 18 months	NA mmHg
Intervention	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Diastolic blood pressure, 18 months	NA mmHg
Control	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Systolic blood pressure, 18 months	NA mmHg
Control	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Systolic blood pressure, 12 months	-4.89 mmHg
Control	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Diastolic blood pressure, 6 months	-1.36 mmHg
Control	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Diastolic blood pressure, 12 months	-2.32 mmHg
Control	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Diastolic blood pressure, 18 months	NA mmHg
Control	Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months	Systolic blood pressure, 6 months	-4.01 mmHg

95% CI: [-2.15, 1.4]

95% CI: [-1.29, 1.32]

Secondary