Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy

Last updated: May 16, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

Meal Delivery

Clinical Study ID

NCT05512247
IRB-300009764
P50MD017338
  • Ages > 18
  • Female

Study Summary

This study is being done to assess the feasibility, acceptability, and preliminary impact of a meal delivery intervention designed to improve diet quality and promote appropriate gestational weight gain among predominantly Black and low-income pregnant women with overweight or obesity. This will be done by 1) assessing the feasibility and acceptability of the meal delivery intervention; 2) investigating changes in patient-reported diet quality, barriers to healthy eating, and food security; and 3) exploring the preliminary impact of the meal delivery intervention on gestational weight gain and blood pressure and estimate the effect size of the intervention relative to a de-identified non-randomized control group that will be derived from de-identified hospital records.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medicaid eligible and/or have a household income at or below 185 percent of thefederal poverty line

  • 18 years of age or older

  • <= 19 weeks gestation

  • Currently experiencing a singleton pregnancy

  • Receiving prenatal care at a University of Alabama at Birmingham clinic

  • Planning to deliver at the University of Alabama at Birmingham

  • Residing within the meal company's delivery radius

  • Body mass index >= 25

  • Willing to consent

Exclusion

Exclusion Criteria:

  • Self-reported major health condition (such as renal disease, cancer, or Type 1 orType 2 diabetes)

  • Current treatment for severe psychiatric disorder (such as schizophrenia)

  • Current substance abuse

  • Self-reported diagnosis of anorexia or bulimia

  • Known fetal anomaly

  • Current use of medication expected to significantly impact body weight

  • Planned termination of the current pregnancy

  • Participation in another dietary and/or weight management intervention during thecurrent pregnancy

  • Unwilling or unable to understand and communicate in English

  • Unwilling or unable to consume study meals

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: Meal Delivery
Phase:
Study Start date:
October 05, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

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