Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,618
- 试验地点
- 17
- 主要终点
- Parent physical activity
研究概览
简要总结
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung & Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6618 participants in total (i.e., 3309 mother-child dyads which includes 3309 mothers and 3309 children) from diverse community settings with a high burden of cardiovascular disease risk factors.
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
- Double (Participant, Outcomes Assessor)
盲法说明
cluster randomized at the home visiting supervisor level, stratified within home visiting agencies
Participants are masked throughout the study enrollment process (e.g., recruitment, consent, and baseline data collection). Participant may become unmasked to treatment arm after enrollment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be currently enrolled in an evidence-based home visiting program participating in ENRICH
- •Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)
- •Be 18 years of age or older
- •Speak English or Spanish
排除标准
- •There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.
研究组 & 干预措施
ENRICHed home visiting
Home Visiting with the addition of cardiovascular health promotion content
干预措施: ENRICH (Behavioral)
Usual Home Visiting
Usual home visiting without cardiovascular health promotion content
干预措施: Usual Home Visiting (Behavioral)
结局指标
主要结局
Parent physical activity
时间窗: 12 months after birth
Time spent in moderate and vigorous physical activity in parent participants
Parent blood pressure
时间窗: 12 months after birth
blood pressure (BP) in parent participants
Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale
时间窗: 12 months after birth
Diet quality among parent participants as measured by Mediterranean Eating Pattern for Americans (MEPA) scale. The MEPA is a 16-item dietary screener designed to assess accordance with the Mediterranean-like diet patterns during the past 7 days among adults. A score of '0' will be given if the scoring condition is not met and a score of '1' will be given if the scoring condition is met. A score of '1' for any given item was indicative of Mediterranean-like diet accordance. If any condition was not met, a score of '0' was recorded for that item. The total MEPA score could range from 0 to 16. Scores will be converted to points on a 100-point scale based on quantiles of the 16-item measure. For example, scores from 0-3 (0 points), 4-7 (25 points), 8-11 (50 points), 12-14 (80 points), and 15-16 (100 points). Higher scores mean that the adult's diet is similar to a Mediterranean diet.
Parent body mass index
时间窗: 12 months after birth
Body mass index (BMI) of parent participants
次要结局
- Child body mass index(24 months old)