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

University of Vermont

Status: Enrolling

Conditions: Food Security

Treatments: Other: NE + Meal Delivery (NE+MD) intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07251283

STUDY00003125

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Nutritional Education (NE) control condition

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: NE + Meal Delivery (NE+MD) intervention