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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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, stre

Detailed Summary:
Sponsor: Institute of Nutrition of Central America and Panama

Current Primary Outcome: Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months [ Time Frame: 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


Original Primary Outcome:

  • Change from Baseline in Systolic Blood Pressure at 6, 12, and 18 months [ Time Frame: 6, 12, and 18 months ]
    A reduction in systolic blood pressure is expected as early as 6 months of intervention and this reduction is kept or even continue to decrease over time
  • Change from Baseline in Diastolic Blood Pressure at 6, 12, and 18 months [ Time Frame: 6, 12, and 18 months ]
    A reduction in diastolic blood pressure is expected as early as 6 months of intervention and this reduction is kept or even continue to decrease over time


Current Secondary Outcome:

  • Change From Baseline in Food Intake at 12 Months [ Time Frame: Baseline and 12 months ]
  • Change From Baseline in Body Weight at 12 Months [ Time Frame: Baseline and 12 months ]
  • Change From Baseline in Body Mass Index at 12 Months [ Time Frame: Baseline and 12 months ]
  • Change From Baseline in Waist Circumference at 12 Months [ Time Frame: Baseline and 12 months ]
  • Change From Baseline in Physical Activity at 12 Months [ Time Frame: Baseline and 12 months ]


Original Secondary Outcome:

Information By: Institute of Nutrition of Central America and Panama

Dates:
Date Received: February 11, 2011
Date Started: September 2011
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017