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

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Diet, Healthy; Pregnancy

Treatments: Behavioral: Meal Delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05512247

IRB-300009764

P50MD017338 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

Meal Delivery

Experimental group

Description:

Behavioral intervention program designed to improve diet quality and promote healthy weight gain in women with overweight/obesity through meal delivery and behavioral strategies during pregnancy.

Treatment:

Behavioral: Meal Delivery