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

NCT05512247 | Active Not Recruiting

• 2 other identifiers: IRB-300009764P50MD017338
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diet, Healthy; Pregnancy

Keywords

Meal Delivery; Maternal Overweight or Obesity; Blood Pressure; Food Security; Pregnancy; Gestational Weight Gain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Food Security

  baseline (18-22 weeks gestation), (33-37 weeks gestation)

• Change in Barriers to Healthy Eating

  baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)

• Study Participation Rate

  baseline (18-22 weeks gestation)

• Participant Retention

  baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)

• Participant Adherence to Intervention

  Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation)

Other Outcomes (2)

• Change in Blood Pressure

  First prenatal visit through delivery (Collected once at study end from medical record)

• Gestational weight gain

  First prenatal visit through delivery (Collected once at study end from medical record)

Study Arms (1)

Meal Delivery

EXPERIMENTAL

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

Interventions

Meal Delivery BEHAVIORAL

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

Meal Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Obesity; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Study Officials

• Camille S Worthington, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: October 5, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
• 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.

Locations

US (1)