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临床试验/NCT07251283
NCT07251283招募中不适用

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

University of Vermont1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Household food insecurity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >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)

排除标准

  • Significant psychiatric or medical illness
  • Pregnant or nursing

结局指标

主要结局

Household food insecurity

时间窗: Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period

Household food insecurity as measured by the USDA Household Food Security Survey (FSS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stacey C. Sigmon

Professor, PI

University of Vermont

研究点 (1)

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