Meal Delivery for Healthy Eating During Pregnancy

Overseen By Camille S Worthington, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight-impacting medications

Disqualifiers: Diabetes, Schizophrenia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 33

Duration: 20 weeks

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether meal delivery during pregnancy can improve diet quality and support healthy weight gain. It focuses on pregnant women who are predominantly Black, have low income, and experience overweight or obesity. Researchers aim to determine if meal delivery aids in enhancing diet quality, food security, and managing weight and blood pressure. The trial suits pregnant women receiving care at the University of Alabama at Birmingham, with a body mass index of 25 or higher, and living within the meal delivery area. As an unphased trial, it offers participants the chance to contribute to important research that could enhance maternal health and nutrition.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medication expected to significantly impact body weight.

What prior data suggests that this meal delivery intervention is safe for pregnant women?

Research has shown that meal delivery programs can improve health during pregnancy. One study examined a "food is medicine" approach, aiming to reduce issues like food insecurity, stress, and anxiety in pregnant women. These programs have been linked to better health outcomes for mothers and babies.

Meal delivery programs are generally safe and easy to use. They focus on providing healthy meals, which can help manage weight gain and improve overall diet quality. Since this trial does not follow the usual clinical trial phases, it primarily evaluates the program's effectiveness and participant satisfaction, suggesting that safety is not a major concern.

Overall, meal delivery programs aim to support healthy pregnancies by addressing issues like poor nutrition and food insecurity, both of which can lead to negative health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the meal delivery program for pregnant women because it offers a fresh approach to promoting healthy eating habits during pregnancy, especially for those struggling with overweight or obesity. Unlike standard treatments that typically focus on dietary counseling or nutritional supplements, this program provides direct access to nutritious meals, ensuring convenience and adherence. Additionally, by incorporating behavioral strategies, it aims to foster long-term healthy eating patterns, potentially leading to better outcomes for both mothers and their babies.

What evidence suggests that this meal delivery intervention is effective for improving diet quality during pregnancy?

Research shows that better nutrition during pregnancy can help manage weight gain and improve health for both mothers and their babies. One study found that delivering healthy foods can assist low-income pregnant women in managing their weight and improving their diet. Although specific diets during pregnancy haven't consistently been linked to a reduced risk of early birth, they still provide other health benefits. Other studies indicate that nutrition advice often leads pregnant women to improve their health habits and outcomes. This trial will evaluate the effectiveness of a meal delivery program as a behavioral intervention to support healthy eating and weight management during pregnancy. ^{6 7 8 9 10}

Who Is on the Research Team?

Camille S Worthington, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for Black and low-income pregnant women with overweight or obesity who are Medicaid eligible, have a household income below 185% of the federal poverty line, aged 18+, less than 19 weeks into a singleton pregnancy, planning to deliver at UAB, living within the meal delivery area, and willing to consent. Excluded are those unwilling/unable to eat study meals or communicate in English, on weight-impacting meds, with severe health conditions or psychiatric disorders.

Inclusion Criteria

Body mass index >= 25

Residing within the meal company's delivery radius

Planning to deliver at the University of Alabama at Birmingham

Exclusion Criteria

Planned termination of the current pregnancy

I am taking medication that can greatly affect my weight.

Known fetal anomaly

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation to improve diet quality and promote healthy weight gain.

20 weeks

Weekly meal delivery

Follow-up

Participants are monitored for changes in diet satisfaction, food security, and barriers to healthy eating from baseline to follow-up.

4 weeks

Follow-up assessments at 33-37 weeks gestation

What Are the Treatments Tested in This Trial?

Interventions

• Meal Delivery

Trial Overview The study tests if delivering healthy meals can improve diet quality and manage weight gain during pregnancy. It will check how feasible and acceptable this service is among participants; measure changes in their eating habits; assess impacts on gestational weight gain and blood pressure; compare results against data from similar patients not receiving the intervention.

How Is the Trial Designed?

Group I: Meal Delivery Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

Home-delivered meals provided over 5 consecutive days for 6 years did not consistently meet federal guidelines for meal patterns, serving sizes, and food temperatures, indicating potential safety and nutritional concerns.

Despite some deficiencies, these meals contributed significantly to the nutritional needs of recipients, with certain nutrients like protein and iron often exceeding 33% of the Recommended Dietary Allowance (RDA), while others like calcium consistently fell short.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-delivered meals: food quality, nutrient content, and characteristics of recipients. Asp, EH., Darling, ME.[2006]

Home-delivered meal services, like Meals on Wheels, can enhance energy and protein intake for older adults by including protein-enriched options and providing full-day meal plans, according to a systematic review of 19 studies.

Despite the positive outcomes, none of the studies were rated as high quality, highlighting the need for further research to optimize these meal services for better nutritional care at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. IJmker-Hemink, VE., Dijxhoorn, DN., Briseno Ozumbilla, CM., et al.[2020]

Pregnant women in the UK expressed a strong desire for practical support services that help them establish healthy eating habits early in their pregnancy, emphasizing the importance of routine formation.

Participants preferred these services to be led by women with pregnancy experience and suggested marketing through midwives and online platforms to enhance accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting healthy eating in pregnancy: what kind of support services do women say they want? Olander, EK., Atkinson, L., Edmunds, JK., et al.[2016]

A scoping review of 35 studies highlights that individualized dietary treatments can significantly improve food intake and other positive health outcomes for hospitalized patients suffering from malnutrition.

While foodservice strategies that encourage patient choice show promise, and mealtime assistance can enhance food intake, more research is needed to effectively implement and evaluate these 'food first' approaches in acute care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary, food service, and mealtime interventions to promote food intake in acute care adult patients. Cheung, G., Pizzola, L., Keller, H.[2016]

A program providing medically tailored meals (MTM) to recently discharged hospital patients resulted in 65% of participants reporting high satisfaction with the meals, indicating a positive impact on their recovery experience.

Participants noted that the MTM helped them by providing sufficient and healthy food, convenience, and ease of preparation, suggesting that such interventions can support recovery and independence after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perspectives on the impact of receiving medically tailored meals on post-hospitalization. Kelly, C., Gleason, K., Drace, M., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-pregnant-state-10-2022-9c9ef

Meal Delivery for Healthy Eating During Pregnancy Trial Overview The study tests if delivering healthy meals can improve diet quality and manage weight gain during pregnancy. It will check how feasible and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9391971/

Grocery Delivery to Support Healthy Weight Gain Among ... This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325001267

Dietary Patterns and Diet Quality before and/or during ... Studies have not found significant protective effects of improved diet quality through specific dietary patterns during pregnancy for reducing risk of preterm ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07185-z

Effective dietary interventions during pregnancy: a systematic ... Improving dietary intake during pregnancy can mitigate adverse consequences for women and their children. The effective techniques and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687348/

Effectiveness of nutrition counseling for pregnant women in low Our review highlights improvements in maternal behavioral and health outcomes through interactive nutrition counseling during pregnancy. However ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829483

Food Insecurity in Pregnancy, Receipt of Food Assistance ... Findings In this cohort study of 19 338 individuals, food insecurity in pregnancy was prevalent at 14.0% and was associated with a higher risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568643/

Improving Maternal Health and Birth Outcomes Through ... This study examines a food-is-medicine approach that aimed to reduce food insecurity, maternal stress, depression, anxiety, preterm labor, and low birthweight.

8. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07499-y

Risk factors for food insecurity and association with prenatal ... Food insecurity has been linked to poor pregnancy outcomes, including gestational diabetes, anemia, and pregnancy-induced hypertension [29], ...

9. jandonline.org jandonline.org/article/S2212-2672(24)00082-0/fulltext

Implementation and Impact of Perinatal Food Is Medicine ... Nutrition insecurity during this time can lead to poor maternal outcomes, including gestational diabetes; anemia; and preeclampsia (ie, ...

10. networkforphl.org networkforphl.org/news-insights/food-insecurity-and-pregnancy-addressing-inequities-through-food-is-medicine-initiatives/

Food Insecurity and Pregnancy: Addressing Inequities ... Babies born to food insecure people are more susceptible to adverse health outcomes, including low birth weight, premature birth, and ...