NCT04477577Completed
First Heroes: Engaging Fathers in the First 1000 Days
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 657 (actual)
- First submitted
- 8 Jul 2020
- Start date
- 4 Aug 2020
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity
- NCT number
- NCT04477577
What you commit to
- Study type: Interventional
- Participants enrolled: 657
- From 4 Aug 2020 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.