First Heroes: Engaging Fathers in the First 1000 Days
First Heroes
1 other identifier
interventional
657
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedNovember 24, 2025
April 1, 2024
3.3 years
July 8, 2020
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Prevalence of rapid infant weight gain
Weight-for-length z-score
Birth to child age 6 months
Prevalence of rapid infant weight gain
Weight-for-length z-score
Birth to child age 12 months
Prevalence of overweight in infants
Weight-for-length ≥97.7th percentile based on World Health Organization standards
Birth to child age 12 months
Prevalence of overweight in infants
Weight-for-length ≥95 percentile based on Center for Disease Control
Birth to child age 12 months
Secondary Outcomes (20)
Maternal post-partum weight retention
Child birth to 6-month postpartum
Maternal post-partum weight retention
Child birth to 12-month postpartum
Maternal diet
Baseline to 6-month postpartum
Maternal diet
Baseline to 12-month postpartum
Maternal physical activity
Baseline to 6-month postpartum
- +15 more secondary outcomes
Other Outcomes (3)
Family enrollment in food assistance programs during intervention period
Baseline to 12 months post partum
Family housing insecurity during intervention period
Baseline to 12 months post partum
Family food insecurity during intervention period
Baseline to 12 months post partum
Study Arms (2)
New Parent Intervention
EXPERIMENTALSafety Control
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (3)
Silver SR, Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. BMC Pregnancy Childbirth. 2022 May 27;22(1):443. doi: 10.1186/s12884-022-04759-z.
PMID: 35624421BACKGROUNDWhooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial. Contemp Clin Trials. 2021 Feb;101:106253. doi: 10.1016/j.cct.2020.106253. Epub 2020 Dec 17.
PMID: 33340750BACKGROUNDWhooten RC, Kotelchuck M, Gonzalez AVC, Johnson N, Kwete G, Luo M, Muir HF, Barth EA, Smith N, Taveras EM. Expectant fathers' health behaviors, infant care intentions, and social-emotional wellbeing in the perinatal period: A latent class analysis and comparison to mothers. Prev Med Rep. 2023 Aug 26;36:102375. doi: 10.1016/j.pmedr.2023.102375. eCollection 2023 Dec.
PMID: 37719794BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elsie Taveras, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Chief
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 20, 2020
Study Start
August 4, 2020
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
November 24, 2025
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share