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Clinical Trials/NCT07168044
NCT07168044Enrolling By InvitationNot Applicable

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

Martha Biddle1 site in 1 country50 target enrollmentStarted: October 21, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Proportion of eligible individuals who enroll in the study

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: CAN-DO (Behavioral)

Outcomes

Primary Outcomes

Proportion of eligible individuals who enroll in the study

Time Frame: 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

Time Frame: Baseline, week 18, and week 30

Retention rates at each time point will be quantified

Change in Veggie Meter scores

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Martha Biddle
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Martha Biddle

Professor

University of Kentucky

Study Sites (1)

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