First Heroes: Engaging Fathers in the First 1000 Days

NCT04477577 | Completed Results

• 1 other identifier: 2019P003739
• Study Type: interventional
• Target: 657
• Locations: 1 country
• Sites: 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.

Conditions

Obesity, Childhood; Overweight and Obesity; Social Determinants of Health; Physical Activity; Feeding Behavior; Sleep; Diet Habit

Keywords

Overweight; Obesity; Social Determinants of Health; Maternal-Child Health

Outcome Measures

Primary Outcomes (4)

• Number of Infants With Rapid Infant Weight Gain

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

  Birth to child age 6 months

• Number of Infants With Rapid Infant Weight Gain

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

  Birth to child age 12 months

• Number of Overweight Infant Participants (WHO Criteria)

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

  Birth to child age 12 months

• Number of Overweight Infant Participants (CDC Criteria)

  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

  Pre-pregnancy to 6-month postpartum

• Maternal Post-partum Weight Retention

  Prepregnancy to 12-month postpartum

• Maternal Diet

  6-month postpartum

• Maternal Diet

  12-month postpartum

• Maternal Physical Activity

  6-month postpartum

Other Outcomes (3)

• Family Enrollment in Food Assistance Programs

  12 months

• Family Housing Insecurity During Intervention Period

  Baseline

• Family Food Insecurity During Intervention Period

  Baseline

Study Arms (2)

New Parent Intervention

EXPERIMENTAL

Behavioral: New Parent Intervention

Safety Control

ACTIVE COMPARATOR

Behavioral: Safety Control

Interventions

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.

New Parent Intervention

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.

Safety Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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: 35624421 BACKGROUND

• Whooten 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: 33340750 BACKGROUND

• Whooten 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: 37719794 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Results Point of Contact

• Title: Dr. Rachel Whooten
• Organization: Massachusetts General Hospital

rwhooten@mgh.harvard.edu

6176434585

Study Officials

• Elsie Taveras, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 11, 2026
• Results First Posted: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)