NCT04477577

First Heroes: Engaging Fathers in the First 1000 Days

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Childhood
• Overweight and Obesity
• Social Determinants of Health
• Physical Activity
• Feeding Behavior
• Sleep
• Diet Habit

Interventions

Type	Name	Description
BEHAVIORAL	New Parent Intervention	This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach.
BEHAVIORAL	Safety Control	This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials.

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2020-07-20
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States