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First Heroes: Engaging Fathers in the First 1000 Days

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

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

Treatments

Behavioral: New Parent Intervention
Behavioral: Safety Control

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04477577
2019P003739

Details and patient eligibility

About

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.

Enrollment

657 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

657 participants in 2 patient groups

New Parent Intervention
Experimental group
Treatment:
Behavioral: New Parent Intervention
Safety Control
Active Comparator group
Treatment:
Behavioral: Safety Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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