100 Participants Needed

Food Program for Malnutrition

Recruiting at 1 trial location
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AN
Overseen ByAida Nielsen, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to assist postpartum women struggling with food insecurity. It compares in-person support (FBM-In person) with a virtual program (FBM-Virtual) to determine which better enhances diet quality, mental health, and other key health aspects like breastfeeding rates and home cooking. Women who face food insecurity and can communicate in English or Spanish may qualify. Participants must not have food allergies or live outside the delivery area. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance support for postpartum women facing food insecurity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the "Food is the Best Medicine" (FBM) programs, available both in-person and online, aim to improve health by providing nutritious food. These programs focus on reducing food insecurity and enhancing diet quality. In previous studies, participants reported better eating habits and improved nutrition, with no major safety concerns identified.

The online version of the program uses digital tools to help participants manage their nutrition and is designed to be as effective as the in-person version. The absence of clear data on negative effects suggests that both versions are generally well-tolerated. Since this trial is not in a typical phase of clinical research, the program's safety is already considered acceptable based on past experiences.

Overall, these programs appear safe and aim to support postpartum women by improving their diet and health without significant risk.12345

Why are researchers excited about this trial?

Researchers are excited about the Food Program for Malnutrition because it explores innovative delivery methods to tackle malnutrition. Unlike standard care options, which often rely on in-person consultations and clinic visits, the FBM-In person and FBM-Virtual programs provide tailored solutions. The FBM-Virtual arm allows participants to receive guidance and support remotely, making it more accessible for individuals who can't easily travel. This flexibility can lead to greater adherence and potentially better outcomes in managing malnutrition. By comparing these methods to traditional home-delivered food, researchers hope to find more efficient and effective ways to combat this condition.

What evidence suggests that this trial's treatments could be effective for improving diet quality and food security?

Studies have shown that the "Food is the Best Medicine" (FBM) program, which provides nutritious food to new mothers, effectively reduces food insecurity and improves diet quality. In this trial, participants may receive either the FBM-In Person or FBM-Virtual program. Research indicates that participants in these programs often eat better and cook more at home. Participants in the FBM-In Person program have reported high satisfaction with the nutritious and high-quality food provided, with many noticing clear benefits. For FBM-Virtual, research suggests that online programs can also enhance diet quality, cooking skills, and nutrition knowledge. These findings support the effectiveness of both FBM-In Person and FBM-Virtual in improving health outcomes for new mothers.23467

Who Is on the Research Team?

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Alexandra van den Berg, MPH, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for food insecure postpartum women who can communicate in English or Spanish. Participants must live within certain zip codes where home-delivered food boxes are available and should not have any dietary allergies.

Inclusion Criteria

Must be food insecure
I can communicate in English or Spanish.

Exclusion Criteria

Not living within the food produce zip code delivery radius
Having any dietary allergies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the FBM-Virtual or FBM-In Person intervention to improve diet quality, food security, and other health outcomes

8-12 weeks
Weekly sessions (virtual or in-person)

Follow-up

Participants are monitored for changes in financial stress, diet quality, and food security status

3 months
1 visit (in-person or virtual) at 3 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

  • FBM-In person
  • FBM-Virtual
  • Home Delivered Food Boxes
Trial Overview The study compares two programs: 'Food is the Best Medicine' (FBM) delivered virtually, and FBM in person. It looks at how these affect diet quality, food security, breastfeeding rates, mental health, cooking at home frequency, and coping strategies for rationing food.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: FBM-VirtualExperimental Treatment2 Interventions
Group II: FBM-In personExperimental Treatment2 Interventions
Group III: home delivered foodActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Published Research Related to This Trial

Recent trials indicate that individualized medical nutrition therapy can significantly improve clinical outcomes for malnourished patients, highlighting the importance of evidence-based medical nutrition (EBMN).
To effectively manage malnutrition, it is essential to integrate clinical judgment, patient preferences, and the latest scientific evidence, which can lead to better treatment strategies for vulnerable medical inpatients.
"Evidence-based medical nutrition - A difficult journey, but worth the effort!"Kaegi-Braun, N., Baumgartner, A., Gomes, F., et al.[2021]
Electronic meal ordering (EMO) systems in hospitals have shown potential benefits such as improved patient satisfaction, decreased food waste, and increased food consumption, based on a review of 23 studies.
However, there is currently no strong evidence that EMO systems significantly impact clinical outcomes, highlighting the need for further research to determine their effectiveness in nutritional monitoring and patient care.
The impact of electronic meal ordering systems on hospital and patient outcomes: A systematic review.Prgomet, M., Li, J., Li, L., et al.[2019]
Telehealth interventions for malnourished older adults significantly improved protein intake by 0.13 g/kg body weight per day and enhanced quality of life, based on a systematic review of nine studies involving 448 participants.
The review suggests that telehealth is an effective way to provide nutrition support, showing trends towards better nutrition status and reduced hospital readmissions, although more robust research is needed to confirm these findings.
Is telehealth effective in managing malnutrition in community-dwelling older adults? A systematic review and meta-analysis.Marx, W., Kelly, JT., Crichton, M., et al.[2018]

Citations

1.foodisthebestmedicine.orgfoodisthebestmedicine.org/
Food is the Best Medicine | Nutrition Support for Post-Partum ...Food is the Best Medicine (FBM) is a collaborative community program that provides nutritious food to women who have just given birth.
Food is Medicine 2024 - UTHealth School of Public HealthFood is Medicine programs have been shown to help individuals and families experiencing food insecurity increase access to nutritious foods and ...
Food is the Best MedicineTo provide nutrient-rich food to postpartum mothers and their newborns, reducing food insecurity, improving diet quality, and improving rates of home cooking.
Food is Medicine: The Effectiveness of Delaware's Feeding ...The Feeding Families program contributes to improving health outcomes among populations with chronic diseases, particularly in reducing BMI and promoting ...
Qualitative Findings from a Food is Medicine Program ...Results: Participants expressed satisfaction with the program, describing the food as nutritious and high-quality. Many reported benefits, such as improved diet ...
Food is Medicine 2024 - UTHealth School of Public HealthFBM will also work to decrease the high rate of maternal deaths and morbidity cases in Central Texas, which are higher among minority.
A Food is Medicine approach to achieve nutrition security ...A Food is Medicine approach to achieve nutrition security and improve health ... Improved food security; inconsistent associations with health outcomes.
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