Trial Outcomes & Findings for Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings (NCT NCT01295216)
NCT ID: NCT01295216
Last Updated: 2017-03-21
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
637 participants
Primary outcome timeframe
Baseline, 6, 12, and 18 months
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
Intervention
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
|
Control
Individuals who receive the usual primary health care
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
321
|
|
Overall Study
COMPLETED
|
266
|
287
|
|
Overall Study
NOT COMPLETED
|
50
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings
Baseline characteristics by cohort
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 Years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
43.2 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
43.4 Years
STANDARD_DEVIATION 8.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=93 Participants
|
173 Participants
n=4 Participants
|
342 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=93 Participants
|
148 Participants
n=4 Participants
|
295 Participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
104 participants
n=93 Participants
|
108 participants
n=4 Participants
|
212 participants
n=27 Participants
|
|
Region of Enrollment
Guatemala
|
105 participants
n=93 Participants
|
108 participants
n=4 Participants
|
213 participants
n=27 Participants
|
|
Region of Enrollment
Peru
|
107 participants
n=93 Participants
|
105 participants
n=4 Participants
|
212 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsA 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
Outcome measures
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
|---|---|---|
|
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Diastolic blood pressure, 18 months
|
NA mmHg
No data were collected at the 18-month time point
|
NA mmHg
No data were collected at the 18-month time point
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Systolic blood pressure, 12 months
|
-5.23 mmHg
Interval -6.45 to -3.86
|
-4.89 mmHg
Interval -6.19 to -3.59
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Diastolic blood pressure, 12 months
|
-2.34 mmHg
Interval -3.28 to -1.41
|
-2.32 mmHg
Interval -3.27 to -1.37
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Systolic blood pressure, 6 months
|
-5.13 mmHg
Interval -6.4 to -3.86
|
-4.01 mmHg
Interval -5.21 to -2.81
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Diastolic blood pressure, 6 months
|
-1.82 mmHg
Interval -2.71 to -0.93
|
-1.36 mmHg
Interval -2.2 to -0.52
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months
Systolic blood pressure, 18 months
|
NA mmHg
No data were collected at the 18-month time point
|
NA mmHg
No data were collected at the 18-month time point
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
|---|---|---|
|
Change From Baseline in Food Intake at 12 Months
Fruit&Veg intake (servings/day)
|
0.35 Servings/day
Interval 0.14 to 0.57
|
0.10 Servings/day
Interval -0.06 to 0.26
|
|
Change From Baseline in Food Intake at 12 Months
High-sodium food intake (servings/day)
|
-0.41 Servings/day
Interval -0.55 to -0.27
|
-0.36 Servings/day
Interval -0.49 to -0.23
|
|
Change From Baseline in Food Intake at 12 Months
High-fat & sugar food intake (servings/day)
|
-1.86 Servings/day
Interval -2.27 to -1.45
|
-1.16 Servings/day
Interval -1.54 to -0.78
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
|---|---|---|
|
Change From Baseline in Body Weight at 12 Months
|
-0.18 kg
Interval -0.66 to 0.29
|
0.48 kg
Interval 0.08 to 0.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
|---|---|---|
|
Change From Baseline in Body Mass Index at 12 Months
|
-0.10 kg/m2
Interval -0.27 to 0.08
|
0.19 kg/m2
Interval 0.03 to 0.35
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
|---|---|---|
|
Change From Baseline in Waist Circumference at 12 Months
|
0.03 cm
Interval -0.71 to 0.77
|
0.61 cm
Interval -0.06 to 1.27
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Intervention
n=316 Participants
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
|
Control
n=321 Participants
Individuals who receive the usual primary health care
|
|---|---|---|
|
Change From Baseline in Physical Activity at 12 Months
|
-88.3 MET/min/week
Interval -318.8 to 142.2
|
-20.7 MET/min/week
Interval -228.0 to 186.6
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Manuel Ramirez-Zea
Institute of Nutrition of Central America and Panama
Phone: +502 24719913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place