First Heroes: Engaging Fathers in the First 1000 Days
- Conditions
- Overweight and ObesityPhysical ActivityFeeding BehaviorSleepObesity, ChildhoodSocial Determinants of HealthDiet Habit
- Interventions
- Behavioral: New Parent InterventionBehavioral: Safety Control
- Registration Number
- NCT04477577
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 657
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description New Parent Intervention New Parent Intervention - Safety Control Safety Control -
- Primary Outcome Measures
Name Time Method Prevalence of rapid infant weight gain Birth to child age 12 months Weight-for-length z-score
Prevalence of overweight in infants Birth to child age 12 months Weight-for-length ≥95 percentile based on Center for Disease Control
- Secondary Outcome Measures
Name Time Method Paternal diet Baseline to 12 months post-partum Average weekly intake of fruits and vegetables
Maternal diet Baseline to 12-month postpartum Average weekly intake of fruits and vegetables
Parental perceived stress 6 month post-partum Perceived Stress Scale - 4-item validated scale
Maternal post-partum weight retention Child birth to 12-month postpartum Weight in kilograms
Maternal physical activity Baseline to 12-month postpartum Days per week physically active for at least 30 minutes per day
Maternal adherence to preventive health services Baseline to 12 months post-partum Number of preventative care visits attended
Paternal physical activity Baseline to 12 months post-partum Days per week physically active for at least 30 minutes per day
Paternal Mean Body Mass Index Baseline to 12-month postpartum Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m\^2.
Paternal prevalence of obesity Baseline to 12-month postpartum Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
Paternal adherence to preventive health services Baseline to 12-month post-partum Number of preventative care visits attended
Prevalence of breastfeeding initiation 6 months post-partum Self-reported response questionnaire
Prevalence of parental post-partum depression 12 month post-partum Patient Health Questionnaire 2 (PHQ-2)
Infant introduction of solid foods 6 months post-partum Self-reported response questionnaire
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States