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Delivering HOPE (Helping Women Optimize Prenatal Equity)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Site details revised at 8 of 8 sites
    • Collaborators expanded, about 4 words
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary completion date: Aug 31, 2028 to Jun 30, 2029
    • Study sites: 0 to 8
    • Study completion date: Dec 31, 2028 to Dec 31, 2029
    • Start date changed from estimate of May 2025 to Jun 24, 2025
    • Eligibility criteria expanded, about 3 words
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Arkansas
79 trials monitored
See 4 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
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.
Trial Details
NCT Number NCT06814509
Lead Sponsor University of Arkansas
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)		 Gestational Weight Gain, Diet, Healthy, Gestational Hypertension, Gestational Diabetes, Pregnancy Complications
Related terms Diabetes, Gestational, Gestational Weight Gain, Hypertension, Pregnancy-Induced, Pregnancy Complications
Enrollment 1,440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov