Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- 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 Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
Detailed Description
Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.