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临床试验/NCT06401694
NCT06401694Enrolling By Invitation不适用

Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services on Older Adults' Health and Well-being

University of Connecticut1 个研究点 分布在 1 个国家目标入组 1,640 人开始时间: 2024年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,640
试验地点
1
主要终点
Diet Quality

研究概览

简要总结

Meals on Wheels of Rhode Island (MOWRI), in partnership with the University of Connecticut (UConn), will implement and evaluate an enhanced version of its Home-Delivered Meals Program (HDMP). The project goal is to implement and test the effectiveness of an enhanced Home-Delivered Meals (HDM) service delivery approach. The enhanced approach includes community health worker (CHW) interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life for older adults. MOWRI participants at the highest nutritional risk will be randomized to receive standard or enhanced services in order to test the effect of the intervention on health-related outcomes. Anticipated outcomes for individuals receiving enhanced services are improvements in measures of diet quality, food and nutrition security, loneliness, and health-related quality of life compared with those receiving standard HDM services.

详细描述

The purpose of the research study is to understand the effectiveness of an enhanced Home-Delivered Meals Program (HDMP) on the health-quality of life for older adults. Specifically, the investigators will study the effectiveness of an enhanced HDMP service delivery approach that includes community health worker interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life, compared to HDMP only. The research will take place among individuals receiving meals from Meals on Wheels Rhode Island (MOWRI). This is a pragmatic randomized controlled trial with the following objectives: 1) to develop a protocol for CHW engagement (assessment, intervention, and follow-up) with participants; 2) to implement the enhanced home delivered meals (HDM) intervention to MOWRI clients at the highest nutritional risk; 3) to evaluate the impact of the enhanced program on diet quality, food and nutrition security, loneliness, and HRQOL in a randomized study; 4) to evaluate program sustainability measures and implement process improvements to increase sustainability; 5) to disseminate program resources that will allow the program to replicate to other HDM programs; and 6) to share evaluation results with key community, policy, and academic partners. Up to 1640 participants who are individuals receiving meals from Meals on Wheels Rhode Island (MOWRI) and are at a high nutritional risk. The outcome measures are diet quality (primary outcome), food security, nutrition security, subjective isolation / loneliness, health-related quality of life (HRQOL).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Adults who are eligible for Title III - funded Meals on Wheels assistance
  • •Can read and speak Spanish or English
  • •Are nutritionally at risk as determined by the Nutrition Risk Assessment
  • •Reside in the state of Rhode Island

排除标准

  • •Cognitive or physical limitations that prevent an individual from giving consent, as assessed by normal interactions by intake staff or study team
  • •Cognitive or physical limitations that prevent an individual from participating in intervention or evaluation activities, as assessed by normal interactions intake staff or study team

研究组 & 干预措施

Enhanced

Experimental

Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags

干预措施: Home-delivered meals (Other)

Enhanced

Experimental

Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags

干预措施: Wellness check and socialization visit (Other)

Enhanced

Experimental

Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags

干预措施: Community Health Worker calls (Behavioral)

Enhanced

Experimental

Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags

干预措施: Supplemental grocery bag (Other)

Usual care

Active Comparator

Home-delivered meals

干预措施: Home-delivered meals (Other)

Usual care

Active Comparator

Home-delivered meals

干预措施: Wellness check and socialization visit (Other)

结局指标

主要结局

Diet Quality

时间窗: 12 weeks

Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score

次要结局

  • Food Security(12 weeks)
  • Nutrition Security(12 weeks)
  • Loneliness(12 weeks)
  • Health-Related Quality of Life(12 weeks)

研究者

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

Caitlin Caspi

Associate Professor

University of Connecticut

研究点 (1)

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