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Enrolling by invitation NCT07168044

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

No phase Interventional Cardiovascular Risk Reduction Cardiovascular Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAN-DO.
Who it may be relevant to
Registry conditions: Cardiovascular Risk Reduction, Cardiovascular Risk. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of eligible individuals who enroll in the study [Time frame: 6 months]
  • Number of participants enrolled at each timepoint [Time frame: Baseline, week 18, and week 30]
  • Change in Veggie Meter scores [Time frame: Baseline, week 18, and week 30]
  • Participant Satisfaction with intervention [Time frame: 30 weeks]
Secondary outcome measures (6)
  • Change in hemoglobin A1c [Time frame: baseline, 18 weeks and 30 weeks]
  • Change in total cholesterol per lipid panel [Time frame: Baseline, 18 and 30 weeks]
  • Change in systolic blood pressure [Time frame: baseline, 18 and 30 weeks]
  • Change in diastolic blood pressure [Time frame: baseline, 18 and 30 weeks]
  • Change in waist circumference [Time frame: baseline, 18 and 30 weeks]
  • Change in diet quality using an HEI index score [Time frame: baseline, 18 and 30 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT07168044 · 103470 · 1013170404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗