跳至主要内容
临床试验/NCT01295216
NCT01295216终止不适用

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

Institute of Nutrition of Central America and Panama3 个研究点 分布在 3 个国家目标入组 637 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
637
试验地点
3
主要终点
Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Intervention

Experimental

Pre-hypertensive subjects who receive mHealth support for 12 months

干预措施: Mobile technology to promote lifestyle modification (Behavioral)

Control

No Intervention

Individuals who receive the usual primary health care

结局指标

主要结局

Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months

时间窗: Baseline, 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

次要结局

  • Change From Baseline in Physical Activity 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 Body Weight at 12 Months(Baseline and 12 months)
  • Change From Baseline in Waist Circumference at 12 Months(Baseline and 12 months)
  • Change From Baseline in Food Intake at 12 Months(Baseline and 12 months)

研究者

发起方
Institute of Nutrition of Central America and Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel Ramirez-Zea

Head, INCAP Comprehensive Center for the Prevention of Chronic Diseases

Institute of Nutrition of Central America and Panama

研究点 (3)

Loading locations...

相似试验