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

Recruiting
18 years of age
Female
Phase N/A

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Overview

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.

Description

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

Eligibility

Inclusion Criteria:

  • Medicaid eligible and/or have a household income at or below 185 percent of the federal 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 Criteria:

  • Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 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 the current pregnancy
  • Unwilling or unable to understand and communicate in English
  • Unwilling or unable to consume study meals

Study details

Diet, Healthy, Pregnancy

NCT05512247

University of Alabama at Birmingham

14 February 2024

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