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Enrolling by Invitation

NCT Number: NCT07168044

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

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.

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Key information

Conditions

Cardiovascular Risk Reduction Cardiovascular Risk

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAN-DO

Behavioral

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

Primary outcomes

  1. 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.

  2. Number of participants enrolled at each timepoint

    Time frame: Baseline, week 18, and week 30

    Retention rates at each time point will be quantified

  3. 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.

  4. 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

  1. Change in hemoglobin A1c

    Time frame: baseline, 18 weeks and 30 weeks

    Hemoglobin A1c will be measured with the Bayer HgA1c point of care machine

  2. Change in total cholesterol per lipid panel

    Time frame: Baseline, 18 and 30 weeks

    Lipids will be measured using Cholestech LDX point of care machine using fingerstick non-fasting blood samples,

  3. Change in systolic blood pressure

    Time frame: baseline, 18 and 30 weeks

    Measurement of systolic blood pressure will be obtained using a digital BP machine

  4. Change in diastolic blood pressure

    Time frame: baseline, 18 and 30 weeks

    Measurement of diastolic blood pressure will be obtained using a digital BP machine

  5. Change in waist circumference

    Time frame: baseline, 18 and 30 weeks

    Waist circumference will be measured using a cloth measuring tape at the point of the umbilicus with minimal clothing

  6. Change in diet quality using an HEI index score

    Time frame: baseline, 18 and 30 weeks

    Diet quality will be assessed using a Frequency Questionnaire (FFQ). The NDSR FFQ provides the data that allows for calculating the Healthy Eating Index. We will use the 2015 index rules. Healthy Eating Index (HEI) 2015 Score and individual component scores will be calculated from the FFQ according to the HEI-2015 guidelines to assess changes in overall diet quality and changes within each component. The range of scores for the Healthy Eating Index 2015 is 0-100. A higher score is considered better and represents meeting more of the recommended dietary guidelines

Sponsors and collaborators

Lead sponsor

Martha Biddle

Other

Registry information

Acronym: Can-Do

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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