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临床试验/NCT01768793
NCT01768793已完成不适用

Weight Management in Obese Pregnant Underserved African American Women

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2012年10月最近更新:
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
267
试验地点
2
主要终点
Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations

研究概览

简要总结

This project will test a novel lifestyle intervention to help overweight and obese socioeconomically disadvantaged African American women achieve healthy weight control during and after pregnancy and improve the health of their offspring. The treatment will be given through an existing national home visiting program, Parents As Teachers (PAT), which will facilitate sustainability and nationwide dissemination, if effective. We hypothesize that compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine recommendations for gestational weight gain.

详细描述

Maternal overweight/obesity and inappropriate gestational weight gain increase both maternal and neonatal morbidity and mortality. In addition, offspring of overweight/obese women are at increased risk for neurodevelopmental delay, becoming obese, and developing metabolic diseases. Women who are socioeconomically disadvantaged (SED), especially from African American populations, are particularly susceptible to adverse pregnancy-related outcomes because of their high prevalence rates of obesity. Therefore, successful weight management during pregnancy in SED, African American women has considerable public health implications. We have experience in testing lifestyle interventions among SED nonpregnant women that have been implemented and sustained within community organizations such as Parents As Teachers (PAT), a national home visiting program that provides parent-child education and services free-of-charge to high-needs women, prenatally and post-partum, with up to 25 home visits per year until kindergarten. We propose to conduct a 24-month (6-month prenatal and 18-month post-partum) randomized, controlled trial in overweight and obese SED African American women to evaluate the ability of an innovative lifestyle intervention program (PAT+), delivered by PAT parent educators during prenatal and post-partum home visits, to improve maternal and neonatal/infant weight, metabolic and health outcomes, relative to the standard PAT program (PAT). A programmatic evaluation will determine the applicability of the PAT+ intervention in real world settings by measuring programmatic reach, implementation, acceptability, and sustainability. If effective, PAT+ can be disseminated through this national organization, which currently reaches over 249,000 mothers and 319,000 children participating in 2,173 PAT programs across all 50 states.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant, African American, Socioeconomically disadvantaged
  • Established prenatal care at our clinic before 15-6/7 weeks gestation
  • Singleton viable pregnancy
  • Gestational age 9 to 15 weeks
  • Body Mass Index (BMI) of 25-45 kg/m²

排除标准

  • Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes
  • Current use of certain medications
  • Contraindications to aerobic exercise in pregnancy
  • History of contraindicated medical conditions

研究组 & 干预措施

Parents As Teachers + Lifestyle Int.

Experimental

Participants assigned to this group will receive Parents As Teachers Plus (PAT+). This will be a diet and physical activity lifestyle intervention integrated within the standard Parents As Teachers home visiting curriculum. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).

干预措施: Parents As Teachers Plus (PAT+) (Behavioral)

Standard Parents as Teachers (PAT)

Active Comparator

Participants assigned to this group will receive the standard Parents As Teachers (PAT) home visiting curriculum, focusing on parenting and child development. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).

干预措施: Standard Parents As Teachers (PAT) (Behavioral)

结局指标

主要结局

Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations

时间窗: Delivery (when the baby is delivered)

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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