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

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.

Study Overview

• Status: Recruiting
• Conditions: Food Security
• Intervention / Treatment: Other: NE + Meal Delivery (NE+MD) intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey Sigmon, Ph.D.; Phone Number: 802-656-9987; Email: ssigmon@uvm.edu

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont
      • Contact: Stacey Sigmon, Ph.D.; Phone Number: 802-656-9987; Email: ssigmon@uvm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Nutritional Education (NE) control condition; Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources.
Experimental: Nutritional Eduction + Meal Delivery (NE+MD) experimental condition; 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.	Other: NE + Meal Delivery (NE+MD) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Household food insecurity	Household food insecurity as measured by the USDA Household Food Security Survey (FSS)	Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period

Collaborators and Investigators

• Sponsor: University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: STUDY00003125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No