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Trial record 81 of 1403 for:    Peru

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

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ClinicalTrials.gov Identifier: NCT01295216
Recruitment Status : Terminated (No significant change for the primary objective at 12 months)
First Posted : February 14, 2011
Results First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Collaborators:
Institute for Clinical Effectiveness and Health Policy
Universidad Peruana Cayetano Heredia
RAND
Information provided by (Responsible Party):
Manuel Ramirez-Zea, Institute of Nutrition of Central America and Panama

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Hypertension
Prehypertension
Intervention Behavioral: Mobile technology to promote lifestyle modification
Enrollment 637
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Period Title: Overall Study
Started 316 321
Completed 266 287
Not Completed 50 34
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care Total of all reporting groups
Overall Number of Baseline Participants 316 321 637
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 316 participants 321 participants 637 participants
43.6  (8.4) 43.2  (8.4) 43.4  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 321 participants 637 participants
Female
169
  53.5%
173
  53.9%
342
  53.7%
Male
147
  46.5%
148
  46.1%
295
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 316 participants 321 participants 637 participants
Argentina 104 108 212
Guatemala 105 108 213
Peru 107 105 212
1.Primary Outcome
Title Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
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Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Overall Number of Participants Analyzed 316 321
Mean (95% Confidence Interval)
Unit of Measure: mmHg
Systolic blood pressure, 12 months
-5.23
(-6.45 to -3.86)
-4.89
(-6.19 to -3.59)
Diastolic blood pressure, 12 months
-2.34
(-3.28 to -1.41)
-2.32
(-3.27 to -1.37)
Systolic blood pressure, 6 months
-5.13
(-6.40 to -3.86)
-4.01
(-5.21 to -2.81)
Diastolic blood pressure, 6 months
-1.82
(-2.71 to -0.93)
-1.36
(-2.20 to -0.52)
Systolic blood pressure, 18 months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Diastolic blood pressure, 18 months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
No data were collected at the 18-month time point
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-2.15 to 1.40
Estimation Comments Systolic blood pressure at 12 months
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-1.29 to 1.32
Estimation Comments Diastolic blood pressure for 12 months
2.Secondary Outcome
Title Change From Baseline in Food Intake at 12 Months
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Overall Number of Participants Analyzed 316 321
Mean (95% Confidence Interval)
Unit of Measure: Servings/day
Fruit&Veg intake (servings/day)
0.35
(0.14 to 0.57)
0.10
(-0.06 to 0.26)
High-sodium food intake (servings/day)
-0.41
(-0.55 to -0.27)
-0.36
(-0.49 to -0.23)
High-fat & sugar food intake (servings/day)
-1.86
(-2.27 to -1.45)
-1.16
(-1.54 to -0.78)
3.Secondary Outcome
Title Change From Baseline in Body Weight at 12 Months
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Overall Number of Participants Analyzed 316 321
Mean (95% Confidence Interval)
Unit of Measure: kg
-0.18
(-0.66 to 0.29)
0.48
(0.08 to 0.90)
4.Secondary Outcome
Title Change From Baseline in Body Mass Index at 12 Months
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Overall Number of Participants Analyzed 316 321
Mean (95% Confidence Interval)
Unit of Measure: kg/m2
-0.10
(-0.27 to 0.08)
0.19
(0.03 to 0.35)
5.Secondary Outcome
Title Change From Baseline in Waist Circumference at 12 Months
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Overall Number of Participants Analyzed 316 321
Mean (95% Confidence Interval)
Unit of Measure: cm
0.03
(-0.71 to 0.77)
0.61
(-0.06 to 1.27)
6.Secondary Outcome
Title Change From Baseline in Physical Activity at 12 Months
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
Overall Number of Participants Analyzed 316 321
Mean (95% Confidence Interval)
Unit of Measure: MET/min/week
-88.3
(-318.8 to 142.2)
-20.7
(-228.0 to 186.6)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

Pre-hypertensive subjects who receive mHealth support for 12 months

Mobile technology to promote lifestyle modification: 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

Individuals who receive the usual primary health care
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/316 (0.00%)   0/321 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/316 (0.00%)   0/321 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manuel Ramirez-Zea
Organization: Institute of Nutrition of Central America and Panama
Phone: +502 24719913
EMail: mramirez@incap.int
Layout table for additonal information
Responsible Party: Manuel Ramirez-Zea, Institute of Nutrition of Central America and Panama
ClinicalTrials.gov Identifier: NCT01295216     History of Changes
Other Study ID Numbers: HHSN268200900028C
First Submitted: February 11, 2011
First Posted: February 14, 2011
Results First Submitted: June 1, 2016
Results First Posted: March 21, 2017
Last Update Posted: March 21, 2017