Empowering Cardiovascular Health in Custodial Grandparents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Modified RICHH
BehavioralThe 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)
BehavioralReferral to primary care provider
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Modified RICHH InterventionExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
4 months after baseline and 6 months after baseline2
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
Time frame
4 months after baseline3
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.
Time frame
At baseline, 4 months after baseline, and 6 months after baseline4
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.
Time frame
At baseline, 4 months after baseline, and 6 months after baselineSecondary outcomes
1
Blood pressure
Measured by the average of three consecutive resting blood pressure measurements (both systolic and diastolic pressures).
Time frame
At baseline, 4 months after baseline, and 6 months after baseline2
Lipids
Measured using non-fasting total cholesterol obtained via finger stick
Time frame
At baseline, 4 months after baseline, and 6 months after baseline3
Hemoglobin A1c (HbA1c)
Measured using non-fasting HbA1c obtained via finger stick
Time frame
At baseline, 4 months after baseline, and 6 months after baseline4
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.
Time frame
At baseline, 4 months after baseline, and 6 months after baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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