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临床试验/NCT06711627
NCT06711627进行中(未招募)不适用

Arkansas Community Engagement Alliance: Delivering Arkansas Perinatal Outcomes for Minority and Rural Women Through Innovative System Improvement to Create Equity

University of Arkansas1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
280
试验地点
1
主要终点
Excessive Gestational Weight Gain (EGWG)

研究概览

简要总结

The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a randomized controlled trial with 400 pregnant women. Participants will be randomized 1:1 to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (~8 weeks post-partum).

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
16 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Aged 16-44 years
  • •<= 22 weeks Pregnant
  • •Speak English, Spanish, or Marshallese
  • •Valid email address
  • •Resides in and plans to give birth in the state of Arkansas

排除标准

  • 未提供

研究组 & 干预措施

Standard of Care (SoC)

Active Comparator

The SoC arm includes implementing the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women. Additionally, participants in the SoC arm will receive $500 after delivery to be used for baby items.

干预措施: Standard of Care (SoC) (Behavioral)

Food Provision

Experimental

The Food Provision arm includes the same nutritional and gestational weight gain counseling provided as standard of care. In addition, participants in the Food Provision arm will be provided with a total of $1000 during their pregnancy to be used specifically for the purchase of healthy foods.

干预措施: Food Provision (Behavioral)

结局指标

主要结局

Excessive Gestational Weight Gain (EGWG)

时间窗: Baseline to Post-partum (approx. 40 weeks)

Pre-pregnancy weight and weight immediately prior to birth will be used to calculate total weight gain, adjusting for pre-pregnancy body mass index and weeks of gestation. Individuals whose total weight gain exceeds established guidelines will be determined to have EGWG.

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 (1)

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