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Completed

NCT Number: NCT04477577

First Heroes: Engaging Fathers in the First 1000 Days

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Infants With Rapid Infant Weight Gain

    Time frame: Birth to child age 6 months

    Defined as an increase in weight-for-age z-score of >0.67 units from birth to 6-months of infant age

  2. Number of Infants With Rapid Infant Weight Gain

    Time frame: Birth to child age 12 months

    Defined as an increase in weight-for-age z-score of >0.67 units from birth to 12-months of infant age

  3. Number of Overweight Infant Participants (WHO Criteria)

    Time frame: Birth to child age 12 months

    Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards

  4. Number of Overweight Infant Participants (CDC Criteria)

    Time frame: Birth to child age 12 months

    Weight-for-length ≥95 percentile based on Center for Disease Control

Secondary outcomes

  1. Maternal Post-partum Weight Retention

    Time frame: Pre-pregnancy to 6-month postpartum

    Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms.

  2. Maternal Post-partum Weight Retention

    Time frame: Prepregnancy to 12-month postpartum

    Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.

  3. Maternal Diet

    Time frame: 6-month postpartum

    Average weekly intake of fruits and vegetables

  4. Maternal Diet

    Time frame: 12-month postpartum

    Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.

  5. Maternal Physical Activity

    Time frame: 6-month postpartum

    Days per week physically active for at least 30 minutes per day

  6. Maternal Physical Activity

    Time frame: 12-month postpartum

    Self-report (Yes/No) of participation in any moderate-vigorous physical activity. Percentage below represents those endorsing YES to participating in moderate vigorous physical activity.

  7. Maternal Adherence to Preventive Health Services

    Time frame: 12 months post-partum

    Endorsing PCP visit in the past year.

  8. Paternal Mean Body Mass Index

    Time frame: Baseline to 6-month postpartum

    Mean change in paternal BMI from baseline to 6 months postpartum, calculated by weight in kilograms and height in meters to report BMI in kg/m^2.

  9. Paternal Mean Body Mass Index

    Time frame: Baseline to 12-month postpartum

    Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2.

  10. Paternal Prevalence of Obesity

    Time frame: Baseline to 12-month postpartum

    Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.

  11. Paternal Adherence to Preventive Health Services

    Time frame: 12-month post-partum

    Endorsement of PCP visit in the past year.

  12. Paternal Diet

    Time frame: 6 months post-partum

    Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.

  13. Paternal Diet

    Time frame: 12 months post-partum

    Average daily intake of fruits and vegetables

  14. Paternal Physical Activity

    Time frame: 6 months post-partum

    Days per week physically active for at least 30 minutes per day

  15. Paternal Physical Activity

    Time frame: 12 months post-partum

    Participation in moderate/vigorous physical activity (Responding YES)

  16. Parental Perceived Stress

    Time frame: 6 month post-partum

    Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.

  17. Prevalence of Parental Post-partum Depression Risk

    Time frame: 6 month post-partum

    Patient Health Questionnaire 2 (PHQ-2), scored from 0 to 6 with higher scores indicating increased risk. For purposes of this measure, 'low depression risk' included score 0-2 and 'depression risk' included score 3-6.

    The percentage reported below represents those with "Increased depression risk (3-6)"

  18. Prevalence of Parental Post-partum Depression

    Time frame: 12 month post-partum

    Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen

  19. Prevalence of Breastfeeding Initiation

    Time frame: 6 months post-partum

    Self-reported response questionnaire - has infant ever been breastfed?

  20. Infant Introduction of Solid Foods

    Time frame: 6 months post-partum

    Age (months) at introduction of solid foods.

Other outcomes

  1. Family Enrollment in Food Assistance Programs

    Time frame: 12 months

    Responding YES to the question: "Does your family currently receive benefits from WIC?"

  2. Family Housing Insecurity During Intervention Period

    Time frame: Baseline

    National Survey of American Families - 2-item validated scale, response of YES to either question was determined positive screen ((1) During the last 12 months, was there a time when you and your family were not able to pay your mortgage, rent or utility bills? (2) During the last 12 months, did you or your children move in with other people even for a little while because you could not afford to pay your mortgage, rent or utility bills?)

  3. Family Food Insecurity During Intervention Period

    Time frame: Baseline

    Hager 2-question validated scale - responded YES to either of two questions relating to household food insecurity ((1) Within the past 12 months we worried whether our food would run out before we got money to buy more (2) Within the past 12 months the food we bought just didn't last and we didn't have money to get more)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Acronym: First Heroes

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2020
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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