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

Study Overview
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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.

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

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

Conditions
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Diet, Healthy, Pregnancy

Intervention / Treatment
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* Behavioral: Meal Delivery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meal Delivery, Maternal Overweight or Obesity, Blood Pressure, Food Security, Pregnancy, Gestational Weight Gain