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First Heroes: Engaging Fathers in the First 1000 Days

NCT04477577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2026-05-11

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Elsie Taveras, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477577 on ClinicalTrials.gov