Delivering HOPE (Helping Women Optimize Prenatal Equity)

Conditions

• Diet, Healthy
• Gestational Diabetes
• Gestational Hypertension
• Gestational Weight Gain
• Pregnancy Complications

Eligibility Criteria

Sex

FEMALE

Age

16 Years - 44 Years

Healthy Volunteers

Accepted

Interventions

• Enhanced Standard of Care (ESoC) — BEHAVIORAL
  Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
• Delivering HOPE — BEHAVIORAL
  ESoC plus healthy food provision

Study Details

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.

Key Dates

Start date

Jun 24, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

1,440 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: 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.
• Experimental: 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).

Primary Outcome Measure

Excessive gestational weight gain (EGWG) [ Time Frame: Baseline to Post-partum (approx. 40 weeks) ]

Central Contacts

• Brett Rowland
  479-713-8000
  [email protected]
• Sarah Pollock
  479-713-8000
  [email protected]

Locations (8)

Find similar trials in Corning, AR

Related Studies

• IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
  PHASE2 · Recruiting · David Ware Branch · New York, New York
• Boston Birth Cohort Study
  Recruiting · Johns Hopkins Bloomberg School of Public Health · Boston, Massachusetts
• Immediate Postpartum Glucose Tolerance Testing
  Recruiting · MemorialCare Health System · Long Beach, California
• Sleep Behaviors in Pregnancy
  Recruiting · University of Michigan · Ann Arbor, Michigan