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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how healthy, customized meals and grocery vouchers can improve conditions like high blood pressure and cholesterol. Participants will be divided into groups to receive either medically tailored meals, grocery vouchers, both, or nutrition counseling. The trial seeks caregivers experiencing food insecurity, with a child aged 6-17 at home, who have been diagnosed with high blood pressure or Type 2 diabetes in the past year. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative solutions for managing health conditions.

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.

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

Research has shown that the treatments under study, such as grocery prescriptions and medically tailored meals (MTMs), are generally safe. Studies have found that grocery prescriptions significantly reduce food insecurity, with no negative effects reported. Specifically, one study showed a 94.1% decrease in food insecurity among participants.

For medically tailored meals, evidence supports their positive impact on health without safety concerns. Studies have linked MTMs to better health outcomes, including fewer hospital visits and lower healthcare costs.

Using both treatments together, MTMs and grocery prescriptions, has improved health without any reported safety issues. Overall, these approaches appear well-tolerated and effective in enhancing health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to address food insecurity with a fresh approach. Traditional methods often rely on food banks or assistance programs that may not offer personalized or health-focused options. In contrast, these treatments involve grocery prescriptions and medically tailored meals, which provide participants with monthly funds for healthy foods or fully prepared meals that cater to specific health needs. This innovative approach not only tackles hunger but also considers individual health requirements, potentially improving overall well-being more effectively than standard options. Additionally, nutrition counseling is included, offering personalized guidance, which can empower participants to make healthier choices long-term.

What evidence suggests that this trial's treatments could be effective for improving health outcomes like blood pressure and cholesterol levels?

This trial will evaluate different nutritional support strategies for food insecurity. Participants in one arm will receive grocery prescriptions. Studies have shown that these prescriptions help people consume more fruits and vegetables and improve their overall diet. Such programs also reduce food insecurity and improve health issues like diabetes and heart health. Another arm will provide medically tailored meals, which research indicates lead to fewer hospital visits and better health for people with complex conditions. A third arm combines grocery prescriptions with medically tailored meals. Early findings suggest this combination effectively addresses both nutritional needs and health outcomes, especially for those with chronic illnesses. ^{1 5 6 7 8}

Who Is on the Research Team?

Alison Gustafson, PhD, MPH, RD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 occasionally use medications that can affect my blood sugar levels.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12440972/

Fresh funds for moms: feasibility of a 12-week online food as ... Fruit and vegetable purchases increased 4% from months one to three (27%–31%), while the percentage of funds spent on meat food items decreased ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... A growing body of evidence suggests that produce prescriptions increase fruit and vegetable (F&V) intake, reduce food insecurity, and improve ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/10/1783/163117/Health-and-Economic-Impact-and-Cost-effectiveness

Health and Economic Impact and Cost-effectiveness of ... Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.

4. jpmph.org jpmph.org/journal/view.php?number=2349

Food is Medicine Initiative for Mitigating Food Insecurity in ... The FIM program includes medically tailored meals, medically tailored groceries, and produce prescriptions. Data suggest that it has lowered ...

5. ruralhealthinfo.org ruralhealthinfo.org/rural-monitor/produce-prescriptions

Produce Prescription Programs Offer 'A Holistic Approach ... Produce prescription programs have gained popularity in recent years as a model for addressing food insecurity and diet-related disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6768858/

A pilot food prescription program promotes produce intake ... The program provided 30 pounds of fresh produce and 4 nonperishable items every 2 weeks, resulting in a 94.1% decrease in food insecurity.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07021391

Supermarket Support for a Primary Care Healthy Food ... The investigators will compare baseline food insecurity to baseline nutrition insecurity rates among participants to assess this measure's ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837765

Healthy Food Benefit Programs, Fruit and Vegetable ... This cohort study evaluates the outcomes of a monthly healthy food benefit program on food security and diet in Seattle.