Empowering Cardiovascular Health in Custodial Grandparents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of participants who complete the intervention and follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Modified RICHH Intervention
The investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents.
干预措施: Modified RICHH (Behavioral)
Standard of Care
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.
干预措施: Standard of Care (SOC) (Behavioral)
结局指标
主要结局
Number of participants who complete the intervention and follow-up
时间窗: 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
时间窗: 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
时间窗: 4 months after baseline
Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy
Food intake
时间窗: 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
时间窗: At baseline, 4 months after baseline, and 6 months after baseline
BMI (kg/m2) will be calculated from height and body weight measured
次要结局
- Lipids(At baseline, 4 months after baseline, and 6 months after baseline)
- Hemoglobin A1c (HbA1c)(At baseline, 4 months after baseline, and 6 months after baseline)
- Nicotine exposure(At baseline, 4 months after baseline, and 6 months after baseline)
- Depressive symptoms(At baseline, 4 months after baseline, and 6 months after baseline)
- Waist circumference(At baseline, 4 months after baseline, and 6 months after baseline)
- Blood pressure(At baseline, 4 months after baseline, and 6 months after baseline)
研究者
MinKyoung Song
Associate Professor
Oregon Health and Science University