跳至主要内容
临床试验/NCT07168044
NCT07168044Enrolling By Invitation不适用

A Community Cardiovascular Disease Risk Reduction Program in Older Adults Engaged in Congregate Nutrition Services (CAN-DO)

Martha Biddle1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月21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
发起方
入组人数
50
试验地点
1
主要终点
Proportion of eligible individuals who enroll in the study

研究概览

简要总结

Investigators plan to test the effect of a Cardiovascular disease (CVD) risk reduction program targeted to improve nutrition and self-management of chronic cardiovascular conditions among older adults participating in congregate meal programs offered at community senior centers.

详细描述

This project proposes utilizing community health workers (CHWs) to deliver targeted health programming to participants in congregate meal programs as part of the Title III-C Nutrition Services Program. By integrating a targeted intervention into these community settings, this proposal aims to enhance individual health outcomes and support healthy nutrition among older adults. This approach prioritizes an evidence based, responsive, community-based solution to the increasingly complex health needs of this expanding population, fostering healthier aging and more resilient communities.

The purpose of this study is to examine the feasibility of a CVD risk reduction program targeted to improve nutrition and self-management of chronic cardiovascular conditions among older adults participating in congregate meal programs offered at community senior centers. The specific aim is to examine the feasibility of a CVD risk reduction program (CAN-DO) delivered to older adults participating in a congregate meal program. The rates of recruitment, retention, acceptance, and participant satisfaction of the intervention protocol, and processes for training and engaging a CHW for intervention delivery in preparation for a larger, fully powered trial will be assessed. Secondary aims will include health outcomes that indicate promise of the intervention's potential effect on cardiovascular risk reduction and will include measurement of hemoglobin A1c, lipid panel, blood pressure, body anthropometrics and nutritional intake (food frequency questionnaire, diet quality with HEI (healthy eating index) scoring, Veggie Meter scores as an indicator of adherence to intervention). These risk factor outcomes will be measured at baseline, 18 weeks (intermediate feasibility) and at 30 weeks to evaluate long term feasibility of the project among older adults participating in a congregate meal program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •community dining site with a minimum of 20 or more congregate meal program participants.
  • •≥ 60 years of age
  • •registered meal program participant at the community dining site
  • •speak English

排除标准

  • •less than 60 years of age
  • •don't participate in baseline measurements

研究组 & 干预措施

CAN DO

Experimental

usual programing offered as part of the congregate meal program plus 18 weekly group education sessions related to CVD risk reduction and nutrition.

干预措施: CAN-DO (Behavioral)

结局指标

主要结局

Proportion of eligible individuals who enroll in the study

时间窗: 6 months

Feasibility will be measured by recruitment rates, the proportion of eligible individuals who enroll during the time required to reach enrollment targets.

Number of participants enrolled at each timepoint

时间窗: Baseline, week 18, and week 30

Retention rates at each time point will be quantified

Change in Veggie Meter scores

时间窗: Baseline, week 18, and week 30

The participant's adherence to the intervention will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.

Participant Satisfaction with intervention

时间窗: 30 weeks

Overall satisfaction will be measured using a likert type scale 0-5, with a higher score equating to greater satisfaction, satisfaction will include measurement of frequency, duration and timing of intervention, total scores will range from 0-15, a mean score for overall satisfaction will be reported

次要结局

  • Change in systolic blood pressure(baseline, 18 and 30 weeks)
  • Change in diastolic blood pressure(baseline, 18 and 30 weeks)
  • Change in waist circumference(baseline, 18 and 30 weeks)
  • Change in hemoglobin A1c(baseline, 18 weeks and 30 weeks)
  • Change in total cholesterol per lipid panel(Baseline, 18 and 30 weeks)
  • Change in diet quality using an HEI index score(baseline, 18 and 30 weeks)

研究者

发起方
Martha Biddle
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Martha Biddle

Professor

University of Kentucky

研究点 (1)

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