Nutritional Support for Food Insecurity

Overseen By Alison Gustafson, PhD, MPH, RD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Alison Gustafson

Must not be taking: Glucocorticoids

Disqualifiers: Bariatric surgery, Pregnancy, Psychosis, others

Compensation: Varies

Number of Visits: 6

280 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who intermittently use medications that affect blood sugar, like glucocorticoids. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Food is Medicine for the whole?

Research shows that food prescription programs, which provide fresh produce and healthy foods, can significantly reduce food insecurity and improve dietary habits. For example, a pilot study found a 94.1% decrease in food insecurity among participants who received fresh produce and nutrition education. ^{1 2 3 4 5}

Is the 'Food is Medicine' approach safe for humans?

The research articles provided do not contain specific safety data for the 'Food is Medicine' approach or similar nutritional support interventions for food insecurity. They focus on the impact of food insecurity on health outcomes rather than the safety of interventions. ^{6 7 8 9 10}

How is the 'Food is Medicine' treatment different from other treatments for food insecurity?

The 'Food is Medicine' treatment is unique because it focuses on providing plant-based foods to improve health and reduce food insecurity, unlike traditional treatments that may not emphasize specific dietary changes. This approach integrates nutrition directly into healthcare by using food as a tool to address both food insecurity and related chronic diseases. ^{1 5 11 12 13}

What is the purpose of this trial?

Food is Medicine for the whole will test an intervention which provides medically tailored meals, or grocery voucher cards, or a combination of these food and nutrition resources to a caregiver and children living in the household. The study will examine how providing healthy tailored food and nutrition services can improve health outcomes, such as blood pressure and cholesterol levels.

Research Team

Alison Gustafson, PhD, MPH, RD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for caregivers and their children living together, where the caregiver has high blood pressure, hypertension, type 2 diabetes, or faces food insecurity. Specific eligibility details are not provided.

Inclusion Criteria

I was diagnosed with severe hypertension or type 2 diabetes in the last year.

English speaking

No plans to move from the area for at least 1 year

Exclusion Criteria

I am considering or have had bariatric surgery.

Lack of telephone which can receive text messages

I do not have a stable place to live or keep food.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive medically tailored meals, grocery vouchers, or a combination to improve health outcomes

12 weeks

Weekly meal deliveries and monthly grocery vouchers

Follow-up

Participants are monitored for changes in health outcomes such as cholesterol levels and blood pressure

6 months

Data collection at baseline, post-intervention, and month 6

Treatment Details

Interventions

• Food is Medicine for the whole

Trial Overview The study tests how providing medically tailored meals, grocery voucher cards, or both can affect health outcomes like blood pressure and cholesterol in households with a caregiver and children.

Participant Groups

Group I: GP (grocery prescription) Active Control 2 Interventions

cards are issued to each participant per month to be spent on eligible healthy food items

Group II: MTM + GP (medically tailored meals and grocery prescription) Active Control 2 Interventions

delivered weekly MTM meals and the GP monthly grocery funds

Group III: MTM (medically tailored meals) Active Control 2 Interventions

Fully prepared meals are delivered on a weekly basis, and tailored to specific health needs

Group IV: Nutrition Counseling Placebo Group 1 Intervention

30 minutes per week of nutrition counseling and assistance. This group will receive the Grocery Prescription package after the last set of study measures are completed

Who Is Running the Clinical Trial?

Alison Gustafson

Lead Sponsor

Trials

4

Recruited

750+

Findings from Research

This systematic review analyzed 21 studies on nutrition interventions aimed at reducing food insecurity, focusing primarily on adult populations, and found that changes in self-reported dietary intake were the main outcomes measured.

The review highlights the need for further research on the long-term feasibility and cost-effectiveness of these interventions, especially in children, as improving nutrition in this group could lead to significant healthcare savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Nutrition Interventions Implemented to Address Food Insecurity as a Social Determinant of Health. Norris, K., Jilcott Pitts, S., Reis, H., et al.[2023]

A pilot program prescribing fresh fruits and vegetables to 60 food-insecure patients led to significant improvements in food security and increased consumption of fruits and certain vegetables, indicating a positive impact on dietary habits.

Participants reported enhanced availability and accessibility of healthy foods, suggesting that fresh food prescription programs can effectively support healthier eating and improve food environments for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Heasley, C., Clayton, B., Muileboom, J., et al.[2021]

In a pilot study involving 172 participants from food-insecure areas, a collaborative food prescription program led to a remarkable 94.1% decrease in food insecurity, highlighting its effectiveness in improving access to nutritious food.

Participants received an average of 29.2 pounds of fresh produce and reported high satisfaction with the program, indicating strong community support and the potential for positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. Aiyer, JN., Raber, M., Bello, RS., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Nutrition Interventions Implemented to Address Food Insecurity as a Social Determinant of Health. [2023]

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

"I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. [2021]

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

A pilot food prescription program promotes produce intake and decreases food insecurity. [2020]

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

Addressing Food Insecurity in a Pediatric Weight Management Clinic: A Pilot Intervention. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Massachusetts General Hospital Revere Food Pantry: Addressing hunger and health at an academic medical center community clinic. [2022]

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

Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016. [2023]

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

Scaling up measurement to confront food insecurity in the USA. [2021]

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

Diet and Food and Nutrition Insecurity and Cardiometabolic Disease. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

People with diabetes, respiratory, liver or mental disorders, higher urinary antimony, bisphenol A, or pesticides had higher food insecurity: USA NHANES, 2005-2006. [2018]

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

Food Insecurity Is Associated With Cardiovascular and All-Cause Mortality Among Adults in the United States. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Doctors have an ethical obligation to ask patients about food insecurity: what is stopping us? [2022]

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

Reprint of: Position of the Academy of Nutrition and Dietetics: Food Insecurity in the United States. [2022]

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

Position of the Academy of Nutrition and Dietetics: Food Insecurity in the United States. [2022]