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OpenTrials
Active, Not Recruiting

NCT Number: NCT06711627

Food Provision in Prenatal Care

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Institute for Community Health Innovation

Springdale, Arkansas, 72762, 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
  • <= 22 weeks Pregnant
  • Speak English, Spanish, or Marshallese
  • Valid email address
  • Resides in and plans to give birth in the state of Arkansas

Treatment and study plan

Standard of Care (SOC)

Behavioral

Standard recommended nutrition and gestational weight gain counseling.

Food Provision

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Arkansas Community Engagement Alliance: Delivering Arkansas Perinatal Outcomes for Minority and Rural Women Through Innovative System Improvement to Create Equity

Acronym: FPPC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2024
Registry last updated
Jun 8, 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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