Food Interventions for Diabetes and Food Insecurity

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Katelyn Fox
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two approaches to help families manage type 1 diabetes (T1DM) and food insecurity. One group receives medically tailored meal kits to simplify planning and preparing balanced meals. The other group receives fresh produce boxes with recipes (produce prescription). Both groups receive nutrition coaching to improve eating habits and manage diabetes more effectively. Families with children aged 5-12 who have T1DM, face food insecurity, and use continuous glucose monitors (devices that track blood sugar levels) might be a good fit for this study. As an unphased trial, this study offers families the chance to explore innovative ways to manage T1DM and food insecurity.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that both medically tailored meal kits and produce prescriptions are generally safe and well-tolerated.

For medically tailored meal kits, studies have found significant benefits with no major safety issues. Recipients experienced less food insecurity and reduced diabetes-related stress. Notably, self-reported cases of low blood sugar decreased from 64% to 47%. Additionally, hospital and nursing home visits were less frequent among those who received the meals.

Produce prescriptions also yield positive results without significant side effects. Participants reported eating more fruits and vegetables and feeling healthier overall. Some studies even noted reductions in blood pressure, blood sugar, and body mass index (BMI) among those who received produce prescriptions.

Both approaches aim to improve diet quality and food security, enhancing health without introducing new risks.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a fresh approach to managing diabetes and food insecurity by focusing on tailored nutrition. Unlike typical diabetes treatments that rely heavily on medication and monitoring, these interventions emphasize food as medicine. The medically tailored meal kits provide families with specific, semi-prepared meals and recipes designed for their health needs, along with coaching to overcome dietary challenges. On the other hand, produce prescriptions deliver a steady supply of fresh fruits and vegetables, encouraging healthier eating habits. Both approaches aim to improve diet quality and empower families with skills to maintain a healthy lifestyle on a budget, which is a novel strategy compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for diabetes and food insecurity?

This trial will compare two interventions for families managing diabetes and food insecurity. Participants in one arm will receive medically tailored meal kits and nutrition coaching. Studies have shown that meal programs specifically designed for people with diabetes can be very helpful. For example, one study found that these meals reduced the percentage of people worried about having enough food from 62% to 42% and lowered instances of low blood sugar from 64% to 47%. Additionally, these meals have been linked to fewer hospital visits and better health, including improved blood sugar control.

Participants in the other arm will receive produce prescriptions and nutrition coaching. Programs that provide fresh fruits and vegetables, known as produce prescription programs, have also shown positive results. Research indicates that these programs can increase fruit and vegetable consumption, reduce worries about having enough food, and improve overall health for those with diabetes. Both types of programs aim to support better nutrition and health for families dealing with diabetes and food insecurity.23467

Are You a Good Fit for This Trial?

This trial is for families with children aged 5-12 who have type 1 diabetes and are experiencing food insecurity. The child must use a continuous glucose monitor, and the family needs to be willing to share this data. Participants should speak English or Spanish.

Inclusion Criteria

My child is 5-12 years old, has type 1 diabetes, and our family struggles with food insecurity.
Child uses a continuous glucose monitor (CGM)
Willing to provide consent for the research team to access CGM data
See 1 more

Exclusion Criteria

I was diagnosed with type 1 diabetes less than 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either medically tailored meal kits or produce prescriptions along with weekly nutrition coaching for 6 weeks

6 weeks
Weekly phone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medically tailored meal kits
  • Produce prescription

Trial Overview

The study compares two approaches: one group gets medically tailored meal kits plus nutrition coaching, while the other receives produce prescriptions plus nutrition coaching. Both interventions last six weeks and aim to improve diet quality and blood sugar control.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Medically tailored meal kits + nutrition coachingExperimental Treatment2 Interventions
Group II: Produce prescription + nutrition coachingActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Katelyn Fox

Lead Sponsor

Citations

Medically Tailored Meals for Food Insecurity and Type 2 ...

The goal of FAME-D is to evaluate the effectiveness of a medically tailored meal plus lifestyle intervention, relative to a food subsidy, on hemoglobin A1c and ...

Medically Tailored Meal Delivery for Diabetes Patients with ...

Food insecurity rates decreased from 62% to 42%, and self-reported hypoglycemia episodes dropped from 64% to 47%, indicating meaningful benefits for vulnerable ...

NCT04828785 | Food As MedicinE for Diabetes

Food insecurity is a major contributor to disparities in diabetes outcomes. Medically tailored meal (MTM) delivery programs are a promising intervention for ...

Association Between Receipt of a Medically Tailored Meal ...

Participation in a medically tailored meals program appears to be associated with fewer hospital and skilled nursing admissions and less overall medical ...

Medically Tailored Meals Work - the Efficacy of ...

Peer-reviewed research has demonstrated that for individuals with complex health conditions, medically tailored meals led to: · 49% fewer inpatient admissions ( ...

Impact of Medically Tailored Meals on Clinical Outcomes ...

Data collected on 72% of those getting the intervention showed significant improvements in food security, as well as reduced diabetes distress, ...

Medically Tailored Food Packages

Some studies found significant improvements in blood pressure and hemoglobin A1c while one study found no effect. Some studies found ...