Delivering HOPE (Helping Women Optimize Prenatal Equity)
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)
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
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
