NCT05512247Completed
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 18 Aug 2022
- Start date
- 5 Oct 2023
- Primary completion date
- 31 May 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity
- NCT number
- NCT05512247
What you commit to
- Study type: Interventional
- Participants enrolled: 17
- From 5 Oct 2023 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of medication expected to significantly impact body weight
Other illness
- 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)
Other
- Current substance abuse
- Self-reported diagnosis of anorexia or bulimia
- Known fetal anomaly
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.