Cardiovascular Disease (CVD) Risk FactorsECGNCT07083895
Empowering Cardiovascular Health in Custodial Grandparents
A study testing Modified RICHH in people with Cardiovascular Disease (CVD) Risk Factors, run by Oregon Health and Science University at 1 site in United States.
Trial summary
In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease (CVD) Risk Factors
- What is being tested?
- Modified RICHH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Grandparent (inclusion):
- Provides full-time care to at least one grandchild (< 18 years old) for at least 6 months, with no biological parent residing in the household or providing substantial care to the children
- Lives in Oregon
- Has English proficiency sufficient for informed consent and completion of study measures
- Provides signed informed consent
Grandparent (exclusion)
- Plans for transfer of care to other caregivers or setting for the next 12 months
- Has significant physical or emotional impairment, or psychiatric illness that might interfere with engagement in their own self-management or that is likely to result in their needing a caregiver in the next 12 months
- Chronic drug abuse
- Current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
MinKyoung Song, PhD, RN, 503-418-2518, songm@ohsu.edu
songm@ohsu.edu
About this study
In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers.
- Being tested
- Modified RICHH, Standard of Care (SOC)
- Keywords
- Rural Caregiver Heart Health Education (RICHH), Custodial grandparents, Grandparent caregivers, Cardiovascular disease (CVD) risk factors, Community health workers, Grandchildren
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified RICHHBehavioural
The RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads. The program consists of 12 weekly sessions [30-45 minutes] that will be held at the caregivers' preferred times. RICHH consists of 6 interactive modules (i.e., self-management for heart health, depressive symptom management, heart healthy eating, physical activity, co-morbid condition management, and adherence to medication and smoking cessation).
The modified RICHH intervention utilizes focus group outcomes to employ modifications needed to target custodial grandparents from varied backgrounds (e.g., high ACEs, SDoH groups).
Standard of Care (SOC)Behavioural
Also called Usual Care
Referral to primary care provider
| Study group | Role | What they receive |
|---|---|---|
| Modified RICHH Intervention | Experimental | The investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents. Receives: Behavioral: Modified RICHH |
| Standard of Care | Active comparator | The usual care control group will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual standard of care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified. Receives: Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the intervention and follow-up
Feasibility is measured by the count of participants who complete the intervention and follow-up components of the study
Measured: 4 months after baseline and 6 months after baseline
Percentage of participants who indicate acceptability of study intervention
Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy
Measured: 4 months after baseline
Physical activity
Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/day). Participants will wear the devices over 7-day periods at each data collection point. For each participant, the average proportion of time per day in moderate-to-vigorous physical activity (MVPA), out of total time wearing the monitors, will be calculated.
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Food intake
Measured using the self-report Viocare Food Frequency Questionnaire. Data from Viocare will be used to generate Healthy Eating Index scores, which range from 0 to 100. Higher scores indicate better dietary quality.
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Body mass index
BMI (kg/m2) will be calculated from height and body weight measured
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Secondary outcomes (6)
Blood pressure
Measured by the average of three consecutive resting blood pressure measurements (both systolic and diastolic pressures).
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Lipids
Measured using non-fasting total cholesterol obtained via finger stick
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Hemoglobin A1c (HbA1c)
Measured using non-fasting HbA1c obtained via finger stick
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Nicotine exposure
Assessed via self-report of cigarette use/inhaled nicotine use, or secondhand smoke exposure. AHA Life's Essential 8 algorithm will generate a score (0-100), with lower scores indicating greater risk.
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Waist circumference
Waist circumference will be measured using a nonextensible tape. At least two independent measurements will be taken and averaged.
Measured: At baseline, 4 months after baseline, and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease (CVD) Risk FactorsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, MinKyoung Song, Oregon Health and Science University
- Investigators
- MinKyoung Song, PhD, RN, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083895
- Sponsor's protocol ID
- STUDY00028858
- Acronym
- ECG
- Status last verified
- May 2026
- First submitted
- 2 Jul 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Cardiovascular Health in Custodial Grandparents
- ClinicalTrials.gov ID
- NCT07083895
- Acronym / sponsor ID
- ECG / STUDY00028858
- Keywords
- Rural Caregiver Heart Health Education (RICHH), Custodial grandparents, Grandparent caregivers, Cardiovascular disease (CVD) risk factors, Community health workers, Grandchildren
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Jul 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.
In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified RICHH Intervention | Experimental | Behavioral: Modified RICHHThe investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents. |
| Standard of Care | Active comparator | Behavioral: Standard of Care (SOC)The usual care control group will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual standard of care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Modified RICHHThe RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads. The program consists of 12 weekly sessions [30-45 minutes] that will be held at the caregivers' preferred times. RICHH consists of 6 interactive modules (i.e., self-management for heart health, depressive symptom management, heart healthy eating, physical activity, co-morbid condition management, and adherence to medication and smoking cessation). The modified RICHH intervention utilizes focus group outcomes to employ modifications needed to target custodial grandparents from varied backgrounds (e.g., high ACEs, SDoH groups). | Behavioural | Modified RICHH Intervention |
| Standard of Care (SOC)Also: Usual CareReferral to primary care provider | Behavioural | Standard of Care |
Primary outcome
Number of participants who complete the intervention and follow-up
Time frame: 4 months after baseline and 6 months after baseline
Feasibility is measured by the count of participants who complete the intervention and follow-up components of the study
Percentage of participants who indicate acceptability of study intervention
Time frame: 4 months after baseline
Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy
Physical activity
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/day). Participants will wear the devices over 7-day periods at each data collection point. For each participant, the average proportion of time per day in moderate-to-vigorous physical activity (MVPA), out of total time wearing the monitors, will be calculated.
Food intake
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Measured using the self-report Viocare Food Frequency Questionnaire. Data from Viocare will be used to generate Healthy Eating Index scores, which range from 0 to 100. Higher scores indicate better dietary quality.
Body mass index
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
BMI (kg/m2) will be calculated from height and body weight measured
6 secondary outcomes
Blood pressure
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Lipids
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Hemoglobin A1c (HbA1c)
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Nicotine exposure
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Depressive symptoms
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Waist circumference
Time frame: At baseline, 4 months after baseline, and 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes
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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.
MinKyoung Song, PhD, RN principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified RICHH in people with Cardiovascular Disease (CVD) Risk Factors, run by Oregon Health and Science University 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?
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: opening soon, as of the sponsor's last update on 27 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MinKyoung Song, PhD, RN (503-418-2518, songm@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the intervention and follow-up (time frame: 4 months after baseline and 6 months after baseline). The study lists 5 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 27 May 2026.