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

NCT07251283 | Recruiting

• 1 other identifier: STUDY00003125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Security

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nutritional Education (NE) control condition

NO INTERVENTION

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

Nutritional Eduction + Meal Delivery (NE+MD) experimental condition

EXPERIMENTAL

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

Interventions

NE + Meal Delivery (NE+MD) intervention OTHER

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.

Nutritional Eduction + Meal Delivery (NE+MD) experimental condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• Significant psychiatric or medical illness
• Pregnant or nursing

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Stacey Sigmon, Ph.D.

CONTACT

802-656-9987; ssigmon@uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PI

Model Details: Randomized, parallel-groups pilot study

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)