Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial

Food Security Clinical Trial

Official title:

Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06374303
• Other study ID #: CHRBSS 00001940
• Status: Completed
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: April 2024
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death.

In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD.

Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions:

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

The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis.

The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100).

Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's<.05), with no changes among NE participants.

This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Eligible participants had to be >18 years old and receiving methadone or buprenorphine treatment for OUD. They had to meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012).

Exclusion Criteria:

Individuals with a significant psychiatric or medical illness were excluded, as were those who were pregnant or nursing.

Related Conditions & MeSH terms

• Food Security
• Opioid-Related Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Household food insecurity Survey	measured using the USDA Household Food Security	3 month study duration