RECRUITING

Delivering HOPE (Helping Women Optimize Prenatal Equity)

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 (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.

Official Title

Delivering HOPE (Helping Women Optimize Prenatal Equity)

Quick Facts

Study Start:2025-06-24
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06814509

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. * ≤18 weeks pregnant
  3. * Speak English, Spanish, or Marshallese
  4. * Valid email address
  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
Sarah Pollock
CONTACT
479-713-8000
SPollack@uams.edu

Principal Investigator

Pearl McElfish, PhD
PRINCIPAL_INVESTIGATOR
University of Arkansas
Lanita White, PharmD
PRINCIPAL_INVESTIGATOR
Community Health Centers of Arkansas

Study Locations (Sites)

1st Choice Healthcare
Corning, Arkansas, 72422
United States
Olly Neal Community Health Center
Marianna, Arkansas, 72360
United States
Boston Mountain Rural Health Center
Marshall, Arkansas, 72650
United States
Mainline Health Systems
Monticello, Arkansas, 71655
United States
Jefferson Comprehensive Care System
Pine Bluff, Arkansas, 71601
United States
River Valley Primary Care Services
Ratcliff, Arkansas, 72951
United States
Community Clinic
Springdale, Arkansas, 72764
United States
East Arkansas Family Health Center
West Memphis, Arkansas, 72301
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Pearl McElfish, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas
  • Lanita White, PharmD, PRINCIPAL_INVESTIGATOR, Community Health Centers 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 Date2025-06-24
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-06-24
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Gestational Weight Gain
  • Diet, Healthy
  • Gestational Hypertension
  • Gestational Diabetes
  • Pregnancy Complications