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

35 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 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. Additionally, home-delivered meal services have been shown to improve dietary intake, which could support weight management. ^{1 2 3 4 5}

Is meal delivery for weight management during pregnancy safe?

Research on meal replacement programs, which are similar to meal delivery, suggests they are generally safe for weight management in women, including those planning pregnancy. These programs have been used in studies without major safety concerns, although individual experiences may vary. ^{3 5 6 7 8}

How does the meal delivery treatment for pregnancy weight management differ from other treatments?

The meal delivery treatment for pregnancy weight management is unique because it involves providing pre-prepared meals to help manage weight during pregnancy, which is different from traditional methods that focus on dietary advice or behavioral interventions. This approach is similar to 'medically tailored meals' used for other conditions, where meals are specifically designed to meet nutritional needs and support health goals. ^{2 5 6 7 9}

What is the purpose of this trial?

This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.

Research Team

Gareth Dutton, PhD

Principal Investigator

University of Alabama at Birmingham

Camille S Worthington, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

A novel in-hospital meal service improves protein and energy intake. [2019]

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

Food Photography Is Not an Accurate Measure of Energy Intake in Obese, Pregnant Women. [2023]

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

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

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

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? [2021]

6. England pubmed.ncbi.nlm.nih.gov

Pre-pregnancy weight loss in women with obesity requesting removal of their intra-uterine contraceptive device in order to conceive: a pilot study of full meal replacement. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of a Partial Meal Replacement Preconception Weight Loss Program for Women with Overweight and Obesity. [2021]

8. Scotland pubmed.ncbi.nlm.nih.gov

Planning, implementation and evaluation of antenatal weight management programmes: What are the key components? A mixed methods study. [2020]

9. United States 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. [2023]