First Heroes: Engaging Fathers in the First 1000 Days

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04477577
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • New Parent Intervention — BEHAVIORAL
    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.
  • Safety Control — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 4, 2020
Status verified
Apr 2026
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
657 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: New Parent Intervention
  • Active Comparator: Safety Control

Primary Outcome Measure

Number of Infants With Rapid Infant Weight Gain [ Time Frame: Birth to child age 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Massachusetts General Hospital· Boston, MA

Related Studies