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)

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Food Program for Malnutrition?

Research shows that telehealth, which is part of the Food Program for Malnutrition, can effectively improve nutrition and quality of life in older adults with malnutrition. Additionally, electronic meal ordering systems in hospitals have been found to support better nutritional management, which can lead to improved patient outcomes.12345

Is the Food Program for Malnutrition safe for humans?

The research on ready-to-use therapeutic foods (RUTF) and similar food-based protocols for treating malnutrition in children suggests they are generally safe. These foods are designed to be nutritious and easy to consume, reducing risks like bacterial contamination from water.678910

How does the FBM treatment for malnutrition differ from other treatments?

The FBM treatment is unique because it offers both in-person and virtual options, allowing for flexible access to nutritional support, which is not commonly available in traditional malnutrition treatments. This approach can help improve coverage and maintain treatment outcomes by integrating patient preferences and modern technology.134811

What is the purpose of this trial?

The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.

Research Team

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Alexandra van den Berg, MPH, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
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+

Findings from Research

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]
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]

References

The impact of electronic meal ordering systems on hospital and patient outcomes: A systematic review. [2019]
Is telehealth effective in managing malnutrition in community-dwelling older adults? A systematic review and meta-analysis. [2018]
"Evidence-based medical nutrition - A difficult journey, but worth the effort!" [2021]
Community-based management of acute malnutrition (CMAM) in sub-Saharan Africa: case studies from Ghana, Malawi, and Zambia. [2017]
Research identified variation in nutrition practice by community prescribing dietitians with regards to the identification and management of malnutrition amongst community dwelling adults. [2021]
Acceptability of Outpatient Ready-To-Use Food-Based Protocols in HIV-Infected Senegalese Children and Adolescents Within the MAGGSEN Cohort Study. [2019]
Comparison of the effectiveness of a milk-free soy-maize-sorghum-based ready-to-use therapeutic food to standard ready-to-use therapeutic food with 25% milk in nutrition management of severely acutely malnourished Zambian children: an equivalence non-blinded cluster randomised controlled trial. [2023]
Comparison of the efficacy of a solid ready-to-use food and a liquid, milk-based diet for the rehabilitation of severely malnourished children: a randomized trial. [2022]
Current and potential role of specially formulated foods and food supplements for preventing malnutrition among 6- to 23-month-old children and for treating moderate malnutrition among 6- to 59-month-old children. [2022]
Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India. [2022]
[Intervention programs in hospital nutrition: actions, design, components and implementation]. [2013]
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