Empowering Cardiovascular Health in Custodial Grandparents

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Disease (CVD) Risk Factors

• Registration Number: NCT07083895
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-10-01
• Primary Completion: 2028-01-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who complete the intervention and follow-up	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
Physical activity	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.
Percentage of participants who indicate acceptability of study intervention	4 months after baseline	Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy
Food intake	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	At baseline, 4 months after baseline, and 6 months after baseline	BMI (kg/m2) will be calculated from height and body weight measured

Secondary Outcome Measures

Name	Time	Method
Lipids	At baseline, 4 months after baseline, and 6 months after baseline	Measured using non-fasting total cholesterol obtained via finger stick
Hemoglobin A1c (HbA1c)	At baseline, 4 months after baseline, and 6 months after baseline	Measured using non-fasting HbA1c obtained via finger stick
Nicotine exposure	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.
Depressive symptoms	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.
Waist circumference	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.
Blood pressure	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).

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States