RECRUITING

Food Provision in Prenatal Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-05-20
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06711627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 16-44 years
  2. * \<= 22 weeks Pregnant
  3. * Speak English, Spanish, or Marshallese
  4. * Valid email address
  5. * Resides in and plans to give birth in the state of Arkansas
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Brett Rowland
CONTACT
479-713-8000
mbrowland@uams.edu
Kelsey Bounds
CONTACT
479-713-8000
krbounds@uams.edu

Study Locations (Sites)

UAMS Institute for Community Health Innovation
Springdale, Arkansas, 72762
United States

Collaborators and Investigators

Sponsor: University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Complications
  • Excessive Gestational Weight Gain