Food Program for Malnutrition

Recruiting at 1 trial location

Overseen By Aida Nielsen, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Outside delivery radius, Dietary allergies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{6 7 9 10 11}

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

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?

Group I: FBM-Virtual Experimental Treatment 2 Interventions

Group II: FBM-In person Experimental Treatment 2 Interventions

Group III: home delivered food Active Control 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Evidence-based medical nutrition - A difficult journey, but worth the effort!" Kaegi-Braun, N., Baumgartner, A., Gomes, F., et al.[2021]

Community-based management of acute malnutrition (CMAM) has been successfully integrated into health systems in Malawi, Ghana, and Zambia, improving service coverage for children under 5 years old.

The implementation of CMAM has led to high cure rates (up to 90% in Malawi) and low death rates (1.7% in Malawi, 2% in Ghana, and 5% in Zambia), demonstrating its efficacy and safety in treating acute malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based management of acute malnutrition (CMAM) in sub-Saharan Africa: case studies from Ghana, Malawi, and Zambia. Maleta, K., Amadi, B.[2017]

The study found that compliance with key nutritional support standards was low, with only 46% adherence to one standard and 82% to another, indicating significant gaps in the management of malnutrition among community-dwelling adults.

Despite high patient satisfaction (86%) with the community prescribing support service, the overall findings suggest a need for quality improvement initiatives to enhance the identification and management of malnutrition, as current practices vary widely among dietitians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research identified variation in nutrition practice by community prescribing dietitians with regards to the identification and management of malnutrition amongst community dwelling adults. Allmark, G., Calder, PC., Marino, LV.[2021]

In a study involving 43 HIV-infected children and adolescents with severe and moderate acute malnutrition, 80% rated the ready-to-use food (RUF) positively in terms of color, taste, smell, and mouth feel, indicating satisfactory initial acceptability.

Despite the positive feedback, adherence to the RUF prescription was only about 50%, and while over half of the participants experienced weight recovery, further research is needed to enhance the palatability of therapeutic foods and provide better psychosocial support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of Outpatient Ready-To-Use Food-Based Protocols in HIV-Infected Senegalese Children and Adolescents Within the MAGGSEN Cohort Study. Cames, C., Varloteaux, M., Have, NN., et al.[2019]

The study compared a milk-free soy-maize-sorghum-based ready-to-use therapeutic food (SMS-RUTF) with standard peanut-based RUTF (P-RUTF) for treating severe acute malnutrition (SAM) in children, involving 824 and 1103 participants respectively.

While the recovery rates for SMS-RUTF (53.3% ITT) were lower than those for P-RUTF (60.8% ITT), the study did not find SMS-RUTF to be equivalent to P-RUTF, particularly in children under 24 months, indicating that SMS-RUTF may not be as effective as the standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Irena, AH., Bahwere, P., Owino, VO., et al.[2023]

In a study of 70 severely malnourished children, those receiving the ready-to-use food (RTUF) had a significantly higher daily energy intake (808 kJ/kg) compared to those on the milk-based diet (F100) (573 kJ/kg), leading to better weight gain.

Children on RTUF gained an average of 15.6 g/kg/day, compared to 10.1 g/kg/day for those on F100, and the rehabilitation duration was shorter for RTUF (13.4 days) versus F100 (17.3 days), indicating RTUF is more effective for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Diop, el HI., Dossou, NI., Ndour, MM., et al.[2022]

Child malnutrition can be effectively addressed by improving diets to include high-quality protein, essential micronutrients, and animal-source foods, as current plant-based diets often lack these critical components.

Supplementary feeding programs need to evolve from traditional fortified blended foods, which have limitations, to more effective options like ready-to-use therapeutic foods (RUTFs) that have shown success in treating severe malnutrition, emphasizing the need for data to compare their impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. de Pee, S., Bloem, MW.[2022]

In a study involving 906 children with uncomplicated severe acute malnutrition, locally prepared ready-to-use therapeutic food (RUTF-L) showed a significantly higher recovery rate of 56.9% compared to 42.8% for augmented energy-dense home-prepared foods (A-HPF).

Both RUTF-L and centrally produced RUTF (RUTF-C) led to faster recovery times and greater weight gain than A-HPF, indicating that RUTF-L is a more effective option for home management of severe acute malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India. Bhandari, N., Mohan, SB., Bose, A., et al.[2022]

Metabolic, Nutrient, and Feeding Intervention Programs are essential for addressing disease-associated malnutrition and improving patient nutritional status through structured policies in medical practice.

The successful implementation of these programs at the Clinical-Surgical 'Hermanos Ameijeiras' Hospital in Cuba demonstrates their feasibility and potential for cost-effective healthcare improvements, requiring minimal investment for training and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intervention programs in hospital nutrition: actions, design, components and implementation]. Santana Porben, S., Barreto Penié, J.[2013]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

The impact of electronic meal ordering systems on hospital and patient outcomes: A systematic review. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Is telehealth effective in managing malnutrition in community-dwelling older adults? A systematic review and meta-analysis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

"Evidence-based medical nutrition - A difficult journey, but worth the effort!" [2021]

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

Community-based management of acute malnutrition (CMAM) in sub-Saharan Africa: case studies from Ghana, Malawi, and Zambia. [2017]

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

Research identified variation in nutrition practice by community prescribing dietitians with regards to the identification and management of malnutrition amongst community dwelling adults. [2021]

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

Acceptability of Outpatient Ready-To-Use Food-Based Protocols in HIV-Infected Senegalese Children and Adolescents Within the MAGGSEN Cohort Study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

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]

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

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]

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

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]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

[Intervention programs in hospital nutrition: actions, design, components and implementation]. [2013]