Food Provision in Prenatal Care

NCT06711627 | Recruiting

• 1 other identifier: 297889
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a randomized controlled trial with 400 pregnant women. Participants will be randomized 1:1 to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).

Conditions

Pregnancy Complications; Excessive Gestational Weight Gain

Outcome Measures

Primary Outcomes (1)

• Excessive Gestational Weight Gain (EGWG)

  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.

  Baseline to Post-partum (approx. 40 weeks)

Study Arms (2)

Standard of Care (SoC)

ACTIVE COMPARATOR

The SoC arm includes implementing the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women. Additionally, participants in the SoC arm will receive $500 after delivery to be used for baby items.

Behavioral: Standard of Care (SoC)

Food Provision

EXPERIMENTAL

The Food Provision arm includes the same nutritional and gestational weight gain counseling provided as standard of care. In addition, participants in the Food Provision arm will be provided with a total of $1000 during their pregnancy to be used specifically for the purchase of healthy foods.

Behavioral: Food Provision

Interventions

Standard of Care (SoC) BEHAVIORAL

Standard recommended nutrition and gestational weight gain counseling.

Standard of Care (SoC)

Food Provision BEHAVIORAL

Standard recommended nutrition and gestational weight gain counseling plus food provision.

Food Provision

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 16-44 years
• \<= 22 weeks Pregnant
• Speak English, Spanish, or Marshallese
• Valid email address
• Resides in and plans to give birth in the state of Arkansas

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Institute for Community Health Innovation

Springdale, Arkansas, 72762, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Brett Rowland

CONTACT

479-713-8000; mbrowland@uams.edu

Kelsey Bounds

CONTACT

479-713-8000; krbounds@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)