Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374303
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder A Randomized Clinical Trial
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The adverse consequences of illicit opioid use eg 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 NEMD participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade refrigerated meals directly to the participants 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 NEMD intervention was associated with significant improvements in household FI with fewer NEMD participants meeting criteria for FI vs NE participants at all three assessment timepoints ps05 Retention rates were similar between the two groups 88 and 84 for NEMD and NE conditions respectively p68 Intervention acceptability was also high with NEMD 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 NEMD participants experienced reductions in depression symptomatology with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 ps05 and no changes among NE participants NEMD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey ie General Health Bodily Pain Mental Health Role Emotional ps05 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 NEMD 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
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 NEMD participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade refrigerated meals directly to the participants 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 NEMD intervention was associated with significant improvements in household FI with fewer NEMD participants meeting criteria for FI vs NE participants at all three assessment timepoints ps05 Retention rates were similar between the two groups 88 and 84 for NEMD and NE conditions respectively p68 Intervention acceptability was also high with NEMD 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 NEMD participants experienced reductions in depression symptomatology with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 ps05 and no changes among NE participants NEMD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey ie General Health Bodily Pain Mental Health Role Emotional ps05 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 NEMD 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None