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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Prehypertension

Intervention / Treatment
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* Behavioral: Mobile technology to promote lifestyle modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pre-hypertensive subjects who receive mHealth support for 12 months | Behavioral: Mobile technology to promote lifestyle modification<br>* 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<br>|
| No Intervention: Control<br>Individuals who receive the usual primary health care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 6, 12, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehypertension, blood pressure, mobile technology, Latin America, behavioral change, healthy lifestyles, mHealth