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

Use of Home-delivered Meals to Manage Cardiometabolic Health During Pregnancy Among Predominantly Black, Low-income Women in Alabama

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy; Diet, Healthy
• Intervention / Treatment: Behavioral: Meal Delivery

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Meal Delivery; 10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Healthy Eating Index score from baseline to follow-up	Determined based on the Healthy Index Score, in which 100 indicates complete alignment with the Dietary Guidelines for Americans and 0 is the minimum score, as calculated from three 24-hour dietary recalls conducted on non-consecutive days (2 weekdays + 1 weekend day) at each time point.	three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Food Security	Determined using the 18-item United States (US) Household Food Security Survey Module based on the previous 30 days. Adult food security scores range from 0 to 10, with lower values indicating greater food security.	baseline (18-22 weeks gestation), (33-37 weeks gestation)
Change in Barriers to Healthy Eating	Participants will be asked to score 5 statements corresponding to different barriers to healthy eating on a 5-point Likert scale ranging from strongly agree to strongly disagree (adapted from Sibai D et al. 2022). Changes in the distribution of responses to each barrier will be assessed, as well as changes in the proportion of women somewhat/strongly agreeing with each barrier will be compared.	baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
Study Participation Rate	Percentage of eligible subjects who agreed to participate out of those who were screened.	baseline (18-22 weeks gestation)
Participant Retention	The proportion of enrolled participants who complete follow-up	baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
Participant Adherence to Intervention	Proportion of weekly study meals participants consumed based on responses to weekly electronic surveys in which participants will report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.	Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation)
Change in Participant Satisfaction with Diet	To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses are average to produce a total diet satisfaction score ranging from 1-5. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning & Preparation Factor will be examined from baseline to follow-up.	baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Pressure	Systolic and diastolic blood pressure measured at each prenatal visit will be retrieved from medical records for all participants at the end of the intervention.	First prenatal visit through delivery (Collected once at study end from medical record)
Gestational weight gain	Weight measured at each prenatal visit will be retrieved from medical records for all participants at the end of the intervention and used to calculate total gestational weight gain and rate of gestational weight gain.	First prenatal visit through delivery (Collected once at study end from medical record)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Camille S Worthington, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Blood Pressure; Gestational Weight Gain; Food Security; Meal Delivery; Maternal Overweight or Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Weight Gain; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Gestational Weight Gain; Obesity
• Other Study ID Numbers: IRB-300009764; P50MD017338 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
• IPD Sharing Access Criteria: Access to IPD stripped of all HIPAA identifiers (except age) for this study can be requested by qualified researchers engaging in independent scientific research whose proposed research has received Institutional Review Board approval, and will be provided following review and approval of a research proposal and timeline, statistical analysis plan, and goals (e.g., manuscripts, presentations, grant applications). The Principal Investigator (PI) and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. Based on institutional policies, execution of a Data Sharing Agreement may be required prior to sharing of IPD. IPD requests can be made to the PI at cschneid@uab.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No