Delivering HOPE (Helping Women Optimize Prenatal Equity)
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…
Conditions studied
Gestational Weight Gain, Diet, Healthy, Gestational Hypertension, Gestational Diabetes, Pregnancy Complications
About this study
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.
Interventions
- Behavioral: Enhanced Standard of Care (ESoC) — Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
- Behavioral: Delivering HOPE — ESoC plus healthy food provision
Primary outcomes
- Excessive gestational weight gain (EGWG) (Baseline to Post-partum (approx. 40 weeks))
Eligibility information
Study locations
- 1st Choice Healthcare, Corning, Arkansas 72422 United States
- River Valley Primary Care Services, Lavaca, Arkansas 72941 United States
- Olly Neal Community Health Center, Marianna, Arkansas 72360 United States
- Boston Mountain Rural Health Center, Marshall, Arkansas 72650 United States
- Mainline Health Systems, Monticello, Arkansas 71655 United States
- Jefferson Comprehensive Care System, Pine Bluff, Arkansas 71601 United States
- Community Clinic, Springdale, Arkansas 72764 United States
- East Arkansas Family Health Center, West Memphis, Arkansas 72301 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.