Clinical trial NCT01295216: Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings
Official title: Mobile Health to Prevent Progression of Pre-hypertension in Latin American Urban Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Prehypertension
Keywords: prehypertension
blood pressure
mobile technology
Latin America
behavioral change
healthy lifestyles
mHealth
Lead sponsor: Institute of Nutrition of Central America and Panama
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Effectiveness and Health Policy
name: Universidad Peruana Cayetano Heredia
name: RAND
First posted: 2011-02-14
Enrollment: 637
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
timeFrame: Baseline, 6, 12, and 18 months
Secondary outcomes:
measure: Change From Baseline in Food Intake at 12 Months
timeFrame: Baseline and 12 months
measure: Change From Baseline in Body Weight at 12 Months
timeFrame: Baseline and 12 months
measure: Change From Baseline in Body Mass Index at 12 Months
timeFrame: Baseline and 12 months
measure: Change From Baseline in Waist Circumference at 12 Months
timeFrame: Baseline and 12 months
measure: Change From Baseline in Physical Activity at 12 Months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Institute for Clinical Effectiveness and Health Policy
city: Guatemala
country: Guatemala
facility: Insitute of Nutrition of Central America and Panama
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
Study officials:
References:
citation: Bernabe-Ortiz A, Pauschardt J, Diez-Canseco F, Miranda JJ. Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial. J Med Internet Res. 2020 Apr 21;22(4):e14595. doi: 10.2196/14595.
citation: Carrillo-Larco RM, Jiwani SS, Diez-Canseco F, Kanter R, Beratarrechea A, Irazola V, Ramirez-Zea M, Rubinstein A, Martinez H, Miranda JJ; GISMAL Group. Implementation Tells Us More Beyond Pooled Estimates: Secondary Analysis of a Multicountry mHealth Trial to Reduce Blood Pressure. JMIR Mhealth Uhealth. 2018 Nov 1;6(11):e10226. doi: 10.2196/10226.
citation: Rubinstein A, Miranda JJ, Beratarrechea A, Diez-Canseco F, Kanter R, Gutierrez L, Bernabe-Ortiz A, Irazola V, Fernandez A, Letona P, Martinez H, Ramirez-Zea M; GISMAL group. 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. Lancet Diabetes Endocrinol. 2016 Jan;4(1):52-63. doi: 10.1016/S2213-8587(15)00381-2. Epub 2015 Dec 1.