Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
New Parent Intervention
  • 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.
Active Comparator
Safety Control
  • 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.

More Details

Status
Active, not recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.