Cardiovascular Risk ReductionCan-DoNCT07168044
A Community Cardiovascular Disease Risk Reduction Program in Older Adults Engaged in Congregate Nutrition Services (CAN-DO)
A study testing CAN-DO in people with Cardiovascular Risk Reduction and Cardiovascular Risk, run by Martha Biddle at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Reduction, Cardiovascular Risk
- What is being tested?
- CAN-DO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2025to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 60 years of age
- don't participate in baseline measurements
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Risk Reduction, Cardiovascular Risk
- Being tested
- CAN-DO
- Keywords
- Community health worker, cardiovascular risk reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN-DOBehavioural
usual programing offered as part of the congregate meal program plus 18 weekly group education sessions related to CVD risk reduction and nutrition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CAN-DO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Number of participants enrolled at each timepoint
Retention rates at each time point will be quantified
Measured: 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.
Measured: 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
Measured: 30 weeks
Secondary outcomes (6)
Change in hemoglobin A1c
Hemoglobin A1c will be measured with the Bayer HgA1c point of care machine
Measured: baseline, 18 weeks and 30 weeks
Change in total cholesterol per lipid panel
Lipids will be measured using Cholestech LDX point of care machine using fingerstick non-fasting blood samples,
Measured: Baseline, 18 and 30 weeks
Change in systolic blood pressure
Measurement of systolic blood pressure will be obtained using a digital BP machine
Measured: baseline, 18 and 30 weeks
Change in diastolic blood pressure
Measurement of diastolic blood pressure will be obtained using a digital BP machine
Measured: baseline, 18 and 30 weeks
Change in waist circumference
Waist circumference will be measured using a cloth measuring tape at the point of the umbilicus with minimal clothing
Measured: baseline, 18 and 30 weeks
Change in diet quality using an HEI index score
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
Measured: baseline, 18 and 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start21 Oct 2025
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martha Biddle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martha Biddle, University of Kentucky
- Investigators
- Martha Biddle, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168044
- Sponsor's protocol ID
- 103470
- Other IDs
- 1013170404
- Acronym
- Can-Do
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Cardiovascular Disease Risk Reduction Program in Older Adults Engaged in Congregate Nutrition Services (CAN-DO)
- ClinicalTrials.gov ID
- NCT07168044
- Acronym / sponsor ID
- Can-Do / 103470
- Conditions
- Cardiovascular Risk Reduction, Cardiovascular Risk
- Keywords
- Community health worker, cardiovascular risk reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Martha BiddleUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAN DO | Experimental | Behavioral: CAN-DOusual programing offered as part of the congregate meal program plus 18 weekly group education sessions related to CVD risk reduction and nutrition. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- less than 60 years of age
- don't participate in baseline measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAN-DOusual programing offered as part of the congregate meal program plus 18 weekly group education sessions related to CVD risk reduction and nutrition. | Behavioural | CAN DO |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Biddle, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAN-DO in people with Cardiovascular Risk Reduction and Cardiovascular Risk, run by Martha Biddle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible individuals who enroll in the study (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.