N/A
N=648
First Heroes: Engaging Fathers in the First 1000 Days
Obesity, Childhood · Overweight and Obesity · Social Determinants of Health · Physical Activity · Feeding Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04477577 ↗Enrolled (actual)
648
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Number of Infants With Rapid Infant Weight Gain — 12; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- New Parent Intervention (Behavioral); Safety Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infants With Rapid Infant Weight Gain |
21; 39 | — |
| PRIMARY Number of Infants With Rapid Infant Weight Gain |
21; 39 | — |
| PRIMARY Number of Overweight Infant Participants (WHO Criteria) |
2; 3 | — |
| PRIMARY Number of Overweight Infant Participants (CDC Criteria) |
4; 8 | — |
| SECONDARY Maternal Post-partum Weight Retention |
2.01; 2.99 | — |
| SECONDARY Maternal Post-partum Weight Retention |
2.01; 2.99 | — |
| SECONDARY Maternal Diet |
54; 71 | — |
| SECONDARY Maternal Diet |
54; 71 | — |
| SECONDARY Maternal Physical Activity |
43; 47 | — |
| SECONDARY Maternal Physical Activity |
43; 47 | — |
| SECONDARY Maternal Adherence to Preventive Health Services |
43; 42 | — |
| SECONDARY Paternal Mean Body Mass Index |
0.16; 0.60 | — |
| SECONDARY Paternal Mean Body Mass Index |
0.16; 0.60 | — |
| SECONDARY Paternal Prevalence of Obesity |
15; 24 | — |
| SECONDARY Paternal Adherence to Preventive Health Services |
31; 32 | — |
| SECONDARY Paternal Diet |
1.7; 1.3 | — |
| SECONDARY Paternal Diet |
1.7; 1.3 | — |
| SECONDARY Paternal Physical Activity |
43; 47 | — |
| SECONDARY Paternal Physical Activity |
43; 47 | — |
| SECONDARY Parental Perceived Stress |
4.74; 4.52; 4.75; 4.42 | — |
| SECONDARY Prevalence of Parental Post-partum Depression Risk |
10; 5; 5; 6 | — |
| SECONDARY Prevalence of Parental Post-partum Depression |
3; 5; 4; 5 | — |
| SECONDARY Prevalence of Breastfeeding Initiation |
84; 90; 75; 79 | — |
| SECONDARY Infant Introduction of Solid Foods |
4.7; 4.5; 4.7; 4.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04477577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.