First Heroes: Engaging Fathers in the First 1000 Days
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 试验地点
- 2
- 主要终点
- Prevalence of rapid infant weight gain
研究概览
简要总结
The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations.
This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental dyads must meet the following criteria:
- •Pregnant females and father of the baby, both aged ≥ 18 years
- •Singleton pregnancy
- •Planned involvement during the first year of the child's life
- •Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system
- •Ability to speak in English or Spanish
- •Capable of giving consent
排除标准
- •Dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20 week ultrasound.
- •Mothers who intend on raising a child alone without any participation from the father of the child.
研究组 & 干预措施
Safety Control
干预措施: Safety Control (Behavioral)
New Parent Intervention
干预措施: New Parent Intervention (Behavioral)
结局指标
主要结局
Prevalence of rapid infant weight gain
时间窗: Birth to child age 12 months
Weight-for-length z-score
Prevalence of overweight in infants
时间窗: Birth to child age 12 months
Weight-for-length ≥97.7th percentile based on World Health Organization standards
次要结局
- Maternal diet(Baseline to 12-month postpartum)
- Parental perceived stress(6 month post-partum)
- Maternal post-partum weight retention(Child birth to 12-month postpartum)
- Maternal physical activity(Baseline to 12-month postpartum)
- Maternal adherence to preventive health services(Baseline to 12 months post-partum)
- Paternal Mean Body Mass Index(Baseline to 12-month postpartum)
- Paternal prevalence of obesity(Baseline to 12-month postpartum)
- Paternal adherence to preventive health services(Baseline to 12-month post-partum)
- Paternal diet(Baseline to 12 months post-partum)
- Paternal physical activity(Baseline to 12 months post-partum)
- Prevalence of breastfeeding initiation(6 months post-partum)
- Prevalence of parental post-partum depression(12 month post-partum)
- Infant introduction of solid foods(6 months post-partum)
- Paternal Mean Body Mass Index(Baseline to 6-month postpartum)
研究者
Elsie Taveras, MD
Division Chief
Massachusetts General Hospital