Actively Recruiting

Phase Not Applicable
Age: 16Years - 44Years
FEMALE
Healthy Volunteers
NCT06711627

Food Provision in Prenatal Care

Led by University of Arkansas · Updated on 2025-07-22

400

Participants Needed

1

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Food Provision in Prenatal Care

Who Can Participate

Age: 16Years - 44Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 16-44 years
  • 22 weeks pregnant or less
  • Speak English, Spanish, or Marshallese
  • Have a valid email address
  • Live in Arkansas and plan to give birth there
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

UAMS Institute for Community Health Innovation

Springdale, Arkansas, United States, 72762

Actively Recruiting

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Research Team

B

Brett Rowland

CONTACT

K

Kelsey Bounds

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Food Provision in Prenatal Care | DecenTrialz