Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings
Primary Purpose
Hypertension, Prehypertension
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mobile technology to promote lifestyle modification
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring prehypertension, blood pressure, mobile technology, Latin America, behavioral change, healthy lifestyles, mHealth
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
Sites / Locations
- Institute for Clinical Effectiveness and Health Policy
- Insitute of Nutrition of Central America and Panama
- Universidad Peruana Cayetano Heredia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Pre-hypertensive subjects who receive mHealth support for 12 months
Individuals who receive the usual primary health care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change From Baseline in Food Intake at 12 Months
Change From Baseline in Body Weight at 12 Months
Change From Baseline in Body Mass Index at 12 Months
Change From Baseline in Waist Circumference at 12 Months
Change From Baseline in Physical Activity at 12 Months
Full Information
NCT ID
NCT01295216
First Posted
February 11, 2011
Last Updated
March 20, 2017
Sponsor
Institute of Nutrition of Central America and Panama
Collaborators
Institute for Clinical Effectiveness and Health Policy, Universidad Peruana Cayetano Heredia, RAND
1. Study Identification
Unique Protocol Identification Number
NCT01295216
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
No significant change for the primary objective at 12 months
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Nutrition of Central America and Panama
Collaborators
Institute for Clinical Effectiveness and Health Policy, Universidad Peruana Cayetano Heredia, RAND
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Prehypertension
Keywords
prehypertension, blood pressure, mobile technology, Latin America, behavioral change, healthy lifestyles, mHealth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
637 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pre-hypertensive subjects who receive mHealth support for 12 months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals who receive the usual primary health care
Intervention Type
Behavioral
Intervention Name(s)
Mobile technology to promote lifestyle modification
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Food Intake at 12 Months
Time Frame
Baseline and 12 months
Title
Change From Baseline in Body Weight at 12 Months
Time Frame
Baseline and 12 months
Title
Change From Baseline in Body Mass Index at 12 Months
Time Frame
Baseline and 12 months
Title
Change From Baseline in Waist Circumference at 12 Months
Time Frame
Baseline and 12 months
Title
Change From Baseline in Physical Activity at 12 Months
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute for Clinical Effectiveness and Health Policy
City
Buenos Aires
Country
Argentina
Facility Name
Insitute of Nutrition of Central America and Panama
City
Guatemala
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
32314970
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.
Results Reference
derived
PubMed Identifier
30389646
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.
Results Reference
derived
PubMed Identifier
26653067
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.
Results Reference
derived
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Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings
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