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

NCT ID: NCT07251283

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-07
• Study Completion Date: 2027-07-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

NE + Meal Delivery (NE+MD) intervention

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Stacey C. Sigmon

Professor, PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stacey Sigmon, Ph.D.

Role: CONTACT

ssigmon@uvm.edu

802-656-9987

Facility Contacts

Stacey Sigmon, Ph.D.

Role: primary

ssigmon@uvm.edu

802-656-9987

Other Identifiers

STUDY00003125

Identifier Type: -

Identifier Source: org_study_id