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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Meal Delivery for healthy eating during pregnancy?

Research on home-delivered meal services shows that providing meals and snacks can improve energy and protein intake and satisfaction, especially in older adults. While this isn't directly about pregnancy, it suggests that meal delivery could help improve nutrition in other groups, like pregnant women, by ensuring they get enough nutrients. ^{1 2 3 4 5}

Is meal delivery generally safe for humans?

Research on home-delivered meals shows they can be safe if proper food handling and delivery procedures are followed to reduce the risk of foodborne illness. Ensuring meals meet safety guidelines, like maintaining the right temperature, is important for safety. ^{6 7 8 9 10}

How does the meal delivery treatment for healthy eating during pregnancy differ from other treatments?

The meal delivery treatment is unique because it provides all meals and snacks directly to pregnant women, addressing common barriers like difficulty in meal planning and expense, which are not typically addressed by other treatments. This approach also includes periodic consultations with a dietitian or nutritionist, offering personalized support that is often lacking in standard dietary guidance during pregnancy. ^{1 11 12 13 14}

Research Team

Camille S Worthington, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary, food service, and mealtime interventions to promote food intake in acute care adult patients. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Improvements in nutritional intake and quality of life among frail homebound older adults receiving home-delivered breakfast and lunch. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Participant perspectives on the impact of receiving medically tailored meals on post-hospitalization. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of two models of nutritional intervention on homebound older adults at nutritional risk. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Health care providers' attitudes toward current food safety recommendations for pregnant women. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Colombia pubmed.ncbi.nlm.nih.gov

[Pregnant women's food safety and nutritional status in Cartagena, Colombia 2011]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Mitigating the risk of food handling in the home-delivered meal program. [2009]

11. England pubmed.ncbi.nlm.nih.gov

5 A Day. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Addressing barriers to maternal nutrition in low- and middle-income countries: A review of the evidence and programme implications. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Promoting healthy eating in pregnancy: what kind of support services do women say they want? [2016]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Eating Behaviors and Dietary Patterns of Women during Pregnancy: Optimizing the Universal 'Teachable Moment'. [2022]