Food Program for Malnutrition
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive either the FBM-Virtual or FBM-In Person intervention to improve diet quality, food security, and other health outcomes
Follow-up
Participants are monitored for changes in financial stress, diet quality, and food security status
What Are the Treatments Tested in This Trial?
Interventions
- FBM-In person
- FBM-Virtual
- Home Delivered Food Boxes
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
American Heart Association
Collaborator