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临床试验/NCT01997151
NCT01997151已完成不适用

Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

Pro-Change Behavior Systems0 个研究点目标入组 374 人开始时间: 2011年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
374
主要终点
Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery

研究概览

简要总结

This program of research tested the effectiveness of an iPad delivered multiple behavior intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It was hypothesized that the intervention would reduce the number of health behavior risks reported by pregnant women in the treatment group. The target behaviors of the intervention are smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption.

详细描述

Promoting health behaviors during pregnancy has tremendous public health significance. Poor health behaviors are associated with pregnancy complications, birth outcomes, and the health of the child. They influence infant birthweight, premature birth, and infant mortality rates, all of which continue to be public health concerns, reflected in the goals of Healthy People 2020.

Pregnant women, particularly those from under-served populations, often have a multitude of health behavior risks that threaten positive pregnancy and birth outcomes, as well as the future health of mother and baby. Pregnancy offers a window of opportunity for behavioral intervention. The immediate health risk for the baby motivates most pregnant women to at least consider changing their behavior. Furthermore, the regular and continual medical care that most pregnant women receive allows optimal access for intervention. The circumstance of pregnancy can be used as a teachable moment to better the future health of women and children.

The primary goals of this study were to complete and enhance the development of an iPad delivered intervention and to assess the efficacy in a randomized clinical trial involving pregnant women from three federally-funded community health centers that treat under-served populations. Using interactive technology, users complete onscreen assessments and receive individually tailored feedback messages on key behavior change strategies identified by the Transtheoretical Model of Behavior Change and matched to their stage of readiness for each behavior. Supplemental intervention components were created including printed feedback reports, a multiple behavior stage-based manual, and Spanish versions of all intervention materials. This intervention offers a cost-effective, science based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of populations of pregnant women.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • At least 18 years old
  • Speak and read either English or Spanish
  • Consent to the research.

排除标准

  • More than 18 weeks gestation

结局指标

主要结局

Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery

时间窗: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery

Health risks were defined as not meeting criteria for smoking (not smoking), fruit and vegetable consumption (eating at least 5 servings a day), and stress management (effectively managing stress).

Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery

时间窗: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery

Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery

时间窗: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery

次要结局

  • Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)(Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery)
  • Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria)(Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery)

研究者

发起方
Pro-Change Behavior Systems
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leanne Mauriello

Vice President of Research and Product Development

Pro-Change Behavior Systems

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