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

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT07251283
Status
Recruiting
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Conditions

  • Food Security

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of VermontBurlingtonVermont05401
Stacey Sigmon, Ph.D.
[email protected]
802-656-9987

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By research site
University of Vermont· Burlington, VT

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