Delivering HOPE (Helping Women Optimize Prenatal Equity)

Not Applicable

Not yet recruiting

• Conditions: Gestational Weight Gain; Diet, Healthy; Gestational Hypertension; Gestational Diabetes; Pregnancy Complications

• Registration Number: NCT06814509
• Lead Sponsor: University of Arkansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-07
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Study Start: 2025-05
• Primary Completion: 2028-08-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1440

Inclusion Criteria

• Aged 16-44 years
• ≤18 weeks pregnant
• Speak English, Spanish, or Marshallese

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Excessive gestational weight gain (EGWG)	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.