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临床试验/NCT04158089
NCT04158089已完成不适用

Holistic Assessment of Tulsa Children's Health

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
2
主要终点
Change from Baseline Self-Reported Smoking Status at 4 months

研究概览

简要总结

The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy using a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 women (ages 18 or older) who are 12-16 weeks pregnant. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. Pre- and post-tests will be used to assess maternal-fetal bonding and smoking before and after the intervention to allow for examination of change across pregnancy. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.

详细描述

Unintended pregnancy (unwanted and/or mistimed pregnancy) heightens the risk for adverse birth outcomes, including preterm birth and very low birth weight (< 1500 grams), which have significant public health costs. Despite decades spent attempting to reduce the proportion of pregnancies that are unintended, nearly half (45%) of all pregnancies are unintended. Among women living in poverty, rates of unintended pregnancy are considerably higher. In this study, investigators focus instead on the reduction of a risky maternal health practice associated with adverse birth outcomes that are more common when pregnancies are unintended: maternal prenatal smoking. The study focuses on rapidly increasing maternal-fetal bonding, a mediator of the relationship between unintended pregnancy and maternal health practices during pregnancy, through a recently piloted intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy. The proposed study will use a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 predominately low-income women (ages 18 or older) who are 12-16 weeks pregnant and planning to continue their pregnancies and be primary caregivers to their infants. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. The 2-week intervention will be conducted within two weeks following Assessment 1. Participants will then be asked to complete a follow-up survey near the beginning of their 3rd trimester to assess maternal-fetal bonding and smoking to allow for examination of change across pregnancy. Impacts of prior interventions to reduce unintended pregnancy and its associated adverse infant outcomes have been modest; reducing the negative association between unintended pregnancy and adverse outcomes through enhancing maternal prenatal attachment makes this project highly significant. This project will be the first to target maternal-fetal bonding through the use of a cellphone-based intervention designed to increase feelings of bonding through attachment and mindfulness exercises, making it highly innovative. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Due to the behavioral design of the intervention, it is impossible to mask participants (who are asked to do tasks) or investigators (who train participants and contact them about tasks). However, care providers are not involved in the study, and the statistical analyses will be conducted with a de-identified data set.

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 of age
  • Between 12-16 weeks pregnant at the time of enrollment.

排除标准

  • Unable to communicate in either English or Spanish
  • Planning to either terminate the pregnancy or place the baby for adoption.

结局指标

主要结局

Change from Baseline Self-Reported Smoking Status at 4 months

时间窗: Through study completion, an average of 1 year

Survey questions asking about frequency, type (vaping vs. combustible); cannabis vs. tobacco; amount (relevant for vaping)

Change from Baseline Maternal-Fetal Attachment at 4 months

时间窗: Through study completion, an average of 1 year

Maternal-Fetal Attachment Scale (MFAS) is a 24-item, Likert type, self-rated scale with five subscales (Cranley, 1981)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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