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临床试验/NCT06814509
NCT06814509招募中不适用

Delivering HOPE (Helping Women Optimize Prenatal Equity)

University of Arkansas11 个研究点 分布在 1 个国家目标入组 1,440 人开始时间: 2025年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,440
试验地点
11
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 (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.

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
  • •≤18 weeks pregnant
  • •Speak English, Spanish, or Marshallese
  • •Valid email address

排除标准

  • 未提供

研究组 & 干预措施

Enhanced Standard of Care (ESoC)

Active Comparator

The ESoC arm includes implementing a standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women; implementing a standard protocol for helping participants sign up for WIC and SNAP; and implementing a standard protocol for providing referrals to safety net food organizations.

干预措施: Enhanced Standard of Care (ESoC) (Behavioral)

Delivering HOPE

Experimental

The Delivering HOPE arm includes providing the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and referral assistance as ESoC. In addition, participants in the Delivering HOPE arm will be provided with funds during their pregnancy to be used specifically for the purchase of healthy foods. The amount will vary based on household size as follows: $1,000 (one to two household members), $2,000 (three to four household members), or $3,000 (five plus household members).

干预措施: Delivering HOPE (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. We will examine the difference in the proportion of women who experience 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 (11)

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