Delivering HOPE (Helping Women Optimize Prenatal Equity)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Arkansas
- Enrollment
- 1,440
- Locations
- 11
- Primary Endpoint
- Excessive gestational weight gain (EGWG)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 44 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 16-44 years
- •≤18 weeks pregnant
- •Speak English, Spanish, or Marshallese
- •Valid email address
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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).
Intervention: Delivering HOPE (Behavioral)
Outcomes
Primary Outcomes
Excessive gestational weight gain (EGWG)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported