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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Diet, Healthy Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive the meal delivery intervention to examine feasibility metrics (e.g., recruitment, attrition, adherence, safety) and pre-post intervention changes. A quasi-experimental design utilizing a comparison group derived from de-identified hospital records will be used for exploratory analyses of intervention impact on gestational weight gain and blood pressure compared to standard care.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.

Study Groups

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Meal Delivery

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.

Group Type EXPERIMENTAL

Meal Delivery

Intervention Type BEHAVIORAL

10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff

Interventions

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Meal Delivery

10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No