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Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2

Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07251283
Enrollment
40
Registered
2025-11-26
Start date
2025-11-07
Completion date
2027-07-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Security

Brief summary

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 status. The main question it aims to answer is: * Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores from intake to Study Week 24 than NE participants? Participants with OUD and FI will be randomly assigned to one of two 24-week experimental conditions: Nutritional Education alone (NE) or NE + Meal Delivery (NE+MD). NE control participants will receive brief NE, a list of FI-related resources in their community, and assistance with contacting any resources of interest. NE+MD participants will receive the same educational platform plus commercial weekly meal deliveries directly to the participant's home (6 meals per week per household member). All participants will complete monthly follow-up assessments throughout the 24-week study measuring food security status, psychosocial functioning, and biometric measures of health. All participants will also complete monthly follow-up assessments for 6 months post-intervention.

Interventions

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.

Sponsors

University of Vermont
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, parallel-groups pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>18 years old * receiving methadone or buprenorphine treatment for OUD * meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012)

Exclusion criteria

* Significant psychiatric or medical illness * Pregnant or nursing

Design outcomes

Primary

MeasureTime frameDescription
Household food insecurityMonthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring periodHousehold food insecurity as measured by the USDA Household Food Security Survey (FSS)

Countries

United States

Contacts

Primary ContactStacey Sigmon, Ph.D.
ssigmon@uvm.edu802-656-9987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026