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

NCT01295216 | Terminated Results

• 1 other identifier: HHSN268200900028C
• Study Type: interventional
• Target: 637
• Locations: 3 countries
• Sites: 3

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.

Conditions

Hypertension; Prehypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Pre-hypertensive subjects who receive mHealth support for 12 months

Behavioral: Mobile technology to promote lifestyle modification

Control

NO INTERVENTION

Individuals who receive the usual primary health care

Interventions

Mobile technology to promote lifestyle modification BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Nutrition of Central America and Panama: lead
• Institute for Clinical Effectiveness and Health Policy: collaborator
• Universidad Peruana Cayetano Heredia: collaborator
• RAND: collaborator

Study Sites (3)

Institute for Clinical Effectiveness and Health Policy

Buenos Aires, Argentina

Location

Insitute of Nutrition of Central America and Panama

Guatemala City, 01011, Guatemala

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Related Publications (3)

• 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.

  PMID: 32314970 DERIVED

• 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.

  PMID: 30389646 DERIVED

• 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.

  PMID: 26653067 DERIVED

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Manuel Ramirez-Zea
• Organization: Institute of Nutrition of Central America and Panama

mramirez@incap.int

+502 24719913

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, INCAP Comprehensive Center for the Prevention of Chronic Diseases

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-03

Locations

PE (1); AR (1); GU (1)