Meal Delivery for Food Security

Overseen By Stacey Sigmon, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must be taking: Methadone, Buprenorphine

Disqualifiers: Significant psychiatric illness, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if home-delivered meals can improve food security for individuals receiving treatment for opioid use disorder. Participants will receive either nutritional education alone or nutritional education plus weekly meal deliveries (NE + Meal Delivery intervention). The study will measure changes in food security, mental health, and overall health over 24 weeks. The trial seeks individuals already receiving methadone or buprenorphine treatment who struggle to obtain enough food. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for those in opioid recovery.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, since participants must be receiving methadone or buprenorphine treatment, it seems you can continue those medications.

What prior data suggests that this meal delivery intervention is safe?

Research has shown that nutrition support programs, such as meal delivery services, are safe and beneficial. One study found that these programs improved food choices and reduced costs. Another study demonstrated a significant drop in food insecurity, decreasing from 100% to just 5.9% after a few weeks of meal delivery.

These findings suggest that meal delivery programs are generally well-received. The reviewed studies did not identify any specific safety concerns. Participants in similar programs have not reported major negative side effects, indicating that the meal delivery aspect of the trial is safe for individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NE + Meal Delivery (NE+MD) intervention because it combines nutritional education with the convenience of home-delivered meals. Unlike traditional approaches that might only offer education or resource lists, this method ensures participants have direct access to nutritious meals, reducing barriers to healthy eating. By delivering premade, refrigerated meals right to the doorstep, it addresses both the knowledge and practical access issues, potentially leading to more immediate improvements in food security and dietary health.

What evidence suggests that the NE+MD intervention could be effective for improving food security?

Research has shown that meal delivery programs can improve food access for people with opioid use disorder (OUD). In one study, 72% of participants who received meal deliveries experienced significant improvements in food access. Another study found that these meal deliveries also reduced complications related to diabetes, indicating health benefits beyond improved food access. In this trial, participants in the Nutritional Education + Meal Delivery (NE+MD) experimental condition will receive both nutrition education and weekly meal deliveries. These findings suggest that the NE+MD program could effectively reduce food insecurity in this group. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with opioid use disorder (OUD) who are currently receiving buprenorphine or methadone and experiencing food insecurity. Participants should be interested in improving their household's food security status.

Inclusion Criteria

I am over 18 years old.

Meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012)

I am currently on methadone or buprenorphine for opioid use disorder.

Exclusion Criteria

Significant psychiatric or medical illness

Pregnant or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either Nutritional Education alone or Nutritional Education plus Meal Delivery for 24 weeks

24 weeks

Monthly follow-up assessments

Follow-up

Participants are monitored for food security status, psychosocial functioning, and biometric measures of health

6 months

Monthly follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• NE + Meal Delivery (NE+MD) intervention

Trial Overview The study tests if a mail-based meal delivery intervention (NE+MD), combined with nutritional education, can better improve food security over 24 weeks compared to just nutritional education (NE). Participants will be randomly placed into one of these two groups.

How Is the Trial Designed?

Group I: Nutritional Eduction + Meal Delivery (NE+MD) experimental condition Experimental Treatment 1 Intervention

NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home.

Group II: Nutritional Education (NE) control condition Active Control 1 Intervention

Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625001267

Novel intervention to improve food insecurity among ... In this randomized study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals with OUD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06374303

Novel Intervention to Improve Food Insecurity Among ... In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07251283?locStr=United+States&country=United+States

Food Insecurity and Eating Behavior Among Adults ... The goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12120087/

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 ...

5. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10972712/

Food Insecurity, Neighborhood Food Environment, and ... Recent studies suggest that providing supplemental funding for food and nutrition education increases the odds of making healthy food choices. •. Explore ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022316625006996

Impacts of Nutrition Policy on Food Insecurity and ... These interventions demonstrate that integrating nutrition support into healthcare delivery can improve outcomes and reduce costs. By ...

8. feedingamerica.org feedingamerica.org/sites/default/files/2023-08/Nutrition%20Education%20Evidence%20Review%20_f.pdf

Key Considerations for Nutrition Education Programs and ... Specifically, this evidence review examines the impact of nutrition education programs and interventions operated in food banks, pantries, and/or related.

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2831308

Preventive Services for Food Insecurity: Evidence Report ... Results One RCT (n = 789) examined the impact of screening for food insecurity and found no difference in food insecurity after 6 months (29.6% ...

10. jpmph.org jpmph.org/journal/view.php?doi=10.3961/jpmph.23.505

Food is Medicine Initiative for Mitigating Food Insecurity in ... The results showed that food insecurity with a baseline value of 100% at week 0 decreased to 10.2% by week 3 of intervention and was at 5.9% by ...