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 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.

Recruiting

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Diet, Healthy Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Gestational Hypertension Glucose Metabolism Disorders Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Vascular Diseases Weight Gain

Age range

16 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

1st Choice Healthcare, Corning, Arkansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 16-44 years
≤18 weeks pregnant
Speak English, Spanish, or Marshallese
Valid email address

Treatment and study plan

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Rowland

CONTACT

[email protected]

479-713-8000

Sarah Pollock

CONTACT

[email protected]

479-713-8000

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Feb 7, 2025
Registry last updated: Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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