NCT07168044

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

August 5, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 21, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

August 5, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Community health workercardiovascular risk reduction

Outcome Measures

Primary Outcomes (4)

  • Proportion of eligible individuals who enroll in the study

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

    6 months

  • Number of participants enrolled at each timepoint

    Retention rates at each time point will be quantified

    Baseline, week 18, and week 30

  • Change in Veggie Meter scores

    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.

    Baseline, week 18, and week 30

  • Participant Satisfaction with intervention

    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

    30 weeks

Secondary Outcomes (6)

  • Change in hemoglobin A1c

    baseline, 18 weeks and 30 weeks

  • Change in total cholesterol per lipid panel

    Baseline, 18 and 30 weeks

  • 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

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: CAN-DO

Interventions

CAN-DOBEHAVIORAL

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

CAN DO

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Study Officials

  • Martha Biddle, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2025

First Posted

September 11, 2025

Study Start

October 21, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations