Meal Delivery for Pregnancy Weight Management

(Her HOME Trial)

Overseen By Amy Dobelstein

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Metformin, Steroids, Antipsychotics, others

Disqualifiers: Diabetes, Substance abuse, Psychiatric disorder, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a meal delivery program can help manage weight gain during pregnancy for women who are overweight or obese. Participants will receive meals and behavioral support to help control weight gain. The trial seeks pregnant women who have a single baby, are in their first trimester, and are receiving care at UAB. Participants must live within the meal delivery area and have internet access at home for the study scale. As an unphased trial, this study offers a unique opportunity to contribute to research that could benefit future pregnancies.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications, including Metformin, systemic steroids, antipsychotic agents, anti-seizure medications, mood stabilizers, ADHD medications like amphetamines and methylphenidate, and any Class D teratogenic agents.

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

Research shows that meal delivery services during pregnancy are generally safe. Studies have found that these services can help control weight gain without major issues. For example, one study reported that women gained less weight during pregnancy and had fewer large babies when using meal delivery, indicating the service is well-received.

Another study found that a similar meal plan improved pregnant women's understanding of nutrition. This knowledge can lead to healthier eating habits, which is a positive sign for safety.

Overall, research suggests that meal delivery services are safe for pregnant women and can help manage weight without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional weight management options for pregnancy, which often rely on dietary advice and self-managed meal planning, the meal delivery intervention offers a practical and supportive approach. This treatment is unique because it provides pre-prepared, nutritious meals directly to expectant mothers, reducing the burden of meal preparation. Additionally, it includes brief behavioral support to help reinforce healthy eating habits. Researchers are excited about this approach because it simplifies adherence to a balanced diet during pregnancy, which can be challenging for many, and has the potential to improve both maternal and fetal health outcomes.

What evidence suggests that this meal delivery intervention is effective for managing gestational weight gain?

Research shows that meal delivery services can help manage weight gain during pregnancy. In this trial, participants will receive a meal delivery intervention with brief behavioral support. These services provide ready-to-eat meals, aiding women in maintaining a healthy weight while pregnant. They also assist in post-birth weight loss, facilitating a return to pre-pregnancy weight. Previous studies that included changes in diet and lifestyle found better weight outcomes for pregnant women. Overall, meal delivery programs hold promise for managing weight gain in pregnant women who are overweight or obese. ^{2 4 6 7 8}

Who Is on the Research Team?

Camille S Worthington, PhD

Principal Investigator

University of Alabama at Birmingham

Gareth Dutton, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 years old, with a BMI of 25 or higher and less than 15 weeks into their pregnancy. They must live within the meal delivery area, have internet at home, and be planning to deliver at UAB. Women on certain medications or with serious health issues like heart disease or diabetes can't join.

Inclusion Criteria

Residing within the delivery radius of the meal delivery company

Body mass index (BMI) ≥ 25 kg/m2

Wi-Fi or Bluetooth Internet connection in home (for digital Wi-Fi enabled study scale)

Exclusion Criteria

I cannot or do not want to eat meals that are delivered to me weekly.

I am currently taking medication that affects my weight or is harmful during pregnancy.

I have or had anorexia or bulimia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a meal delivery intervention with brief behavioral support to manage gestational weight gain

20-23 weeks

Regular prenatal visits

Follow-up

Participants are monitored for changes in weight, diet satisfaction, food insecurity, and perceived stress

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Meal Delivery

Trial Overview The study tests if delivering meals to expectant mothers with overweight or obesity helps manage weight during pregnancy. It checks how well participants accept this service and its initial effectiveness in controlling gestational weight gain.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Meal delivery intervention with brief behavioral support.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The FoodforCare (FfC) meal service significantly improved protein and energy intake among hospitalized patients, with mean daily protein intake increasing from 59% to 79% of requirements on day 1 and from 59% to 73% on day 4 compared to the traditional meal service.

Patient satisfaction with the FfC service was maintained or slightly improved, particularly regarding the appearance and smell of meals, indicating that enhancing meal services can positively impact dietary intake without compromising patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel in-hospital meal service improves protein and energy intake. Dijxhoorn, DN., van den Berg, MGA., Kievit, W., et al.[2019]

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]

A randomized trial involving 264 women with overweight or obesity found that a prenatal behavioral intervention using meal replacements did not significantly help women return to their prepregnancy weight or reduce postpartum weight retention after 12 months.

Despite the intervention reducing excess gestational weight gain, it did not lead to lasting changes in weight control behaviors after delivery, indicating that simply reducing weight gain during pregnancy may not be enough to prevent postpartum weight retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? Phelan, S., Wing, RR., Brannen, A., et al.[2021]

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]

This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.

The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. Law, KK., Coyle, DH., Neal, B., et al.[2023]

Citations

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Weight control program and gestational weight gain in ... A series of randomized controlled trials have evaluated the efficacy of lifestyle interventions (diet and physical activity) during pregnancy on GWG. The ...

2. nature.com nature.com/articles/s41598-025-07979-3

Effectiveness of nutrition literacy intervention on pregnancy ... The CDIP intervention demonstrated significant effectiveness in gestational weight management, with the intervention group showing better weight ...

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Effective dietary interventions during pregnancy: a systematic ... The primary aims of this systematic review and meta-analysis were to summarise the effectiveness of dietary interventions for pregnant woman.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2806186

Key Components of Antenatal Lifestyle Interventions to ... This meta-analysis investigates the association of components of antenatal lifestyle interventions with optimized gestational weight gain ...

5. withpower.com withpower.com/trial/phase-weight-gain-maternal-1-2023-ef6a2

Meal Delivery for Pregnancy Weight Management ... Research suggests that meal replacements during pregnancy can help women return to their pre-pregnancy weight and reduce weight retention after childbirth.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5084910/

One-year postpartum outcomes following a weight ... The intervention ended at delivery and resulted in less gestational weight gain and a lower proportion of large-for-gestational age newborns among intervention ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837845

Metabolic Health and Heterogenous Outcomes of Prenatal ... We observed that with respect to weight changes across pregnancy, individuals with MUO had a 36.7% lower GWG compared with individuals with MHO, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0266613824002262

Effects of an mHealth intervention on maternal and infant ... The birth weight of infants of women in the intervention group was significantly healthier compared to controls. •. The mHealth effect did not persist to reduce ...