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NCT Number: NCT07083895

Empowering Cardiovascular Health in Custodial Grandparents

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.

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Key information

Conditions

Cardiovascular Disease (CVD) Risk Factors Cardiovascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Modified RICHH

Behavioral

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)

Behavioral

Referral to primary care provider

Other names: Usual Care

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. Blood pressure

    Time frame: At baseline, 4 months after baseline, and 6 months after baseline

    Measured by the average of three consecutive resting blood pressure measurements (both systolic and diastolic pressures).

  2. Lipids

    Time frame: At baseline, 4 months after baseline, and 6 months after baseline

    Measured using non-fasting total cholesterol obtained via finger stick

  3. Hemoglobin A1c (HbA1c)

    Time frame: At baseline, 4 months after baseline, and 6 months after baseline

    Measured using non-fasting HbA1c obtained via finger stick

  4. Nicotine exposure

    Time frame: At baseline, 4 months after baseline, and 6 months after baseline

    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.

  5. Depressive symptoms

    Time frame: At baseline, 4 months after baseline, and 6 months after baseline

    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.

  6. Waist circumference

    Time frame: At baseline, 4 months after baseline, and 6 months after baseline

    Waist circumference will be measured using a nonextensible tape. At least two independent measurements will be taken and averaged.

Study contacts

Contact information is provided by the study sponsor or research team.

MinKyoung Song, PhD, RN

CONTACT

[email protected]

503-418-2518

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: ECG

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2025
Registry last updated
May 27, 2026

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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