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临床试验/NCT05802615
NCT05802615已完成不适用

Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial

University of Nebraska1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Feasibility, Adherence

研究概览

简要总结

This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness.

详细描述

The overall objective of this study is to determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black 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
None

入排标准

年龄范围
19 Years 至 51 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Black race
  • •Pregnant with gestational age 20-28 weeks at enrollment
  • •Ability to read and write in English language
  • •Planning to give birth at a healthcare facility & receive obstetrical care with a healthcare record
  • •Reside within 20 minutes of the Lincoln/Omaha, NE metro area
  • •Owns a smartphone with internet access

排除标准

  • 未提供

研究组 & 干预措施

PARITY

Experimental

Participants will take part in the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program which is community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.

干预措施: PARITY (Behavioral)

PARITY

Experimental

Participants will take part in the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program which is community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.

干预措施: Usual Care (Other)

Control

Placebo Comparator

Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

干预措施: Usual Care (Other)

结局指标

主要结局

Feasibility, Adherence

时间窗: Completion of Study (~24 months)

Number of intervention sessions completed by study participants

Feasibility, Attrition

时间窗: Completion of Study (~24 months)

Percentage of eligible individuals who complete the data

Maternal Blood Pressure

时间窗: 6-12 weeks postpartum

Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (\>140/90); Severe hypertension (\>160/110).

Feasibility, Enrollment

时间窗: Baseline

Percentage of eligible individuals who agree to participate in the trial

Maternal Blood Pressure

时间窗: 20 weeks

Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (\>140/90); Severe hypertension (\>160/110).

Maternal Blood Pressure

时间窗: 36 weeks

Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (\>140/90); Severe hypertension (\>160/110).

Maternal Blood Pressure

时间窗: Birth (approximately 36-42 weeks)

Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (\>140/90); Severe hypertension (\>160/110).

次要结局

  • Gestational Weight Gain(20 weeks, 36 weeks, Birth, 6 weeks postpartum.)
  • Delivery Modality(Birth (approximately 36-42 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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