Recruiting

NE & Meal Delivery

Sponsor:

University of Vermont

Code:

NCT07251283

Conditions

Food Security

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NE + Meal Delivery (NE+MD) intervention

Study Details

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

Study ID

NCT07251283

Start date

Nov 7, 2025

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Household food insecurity [ Time Frame: Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period ]

Central Contacts and Locations

Central contacts

Stacey Sigmon, Ph.D.

802-656-9987ssigmon@uvm.edu

Locations

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Stacey Sigmon, Ph.D.

802-656-9987ssigmon@uvm.edu

More Information

Sponsor

University of Vermont

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2025-11-26.