First Heroes: Engaging Fathers in the First 1000 Days (First Heroes)

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Sleep; Obesity, Childhood; Overweight and Obesity; Feeding Behavior; Diet Habit; Social Determinants of Health
• Intervention / Treatment: Behavioral: New Parent Intervention; Behavioral: Safety Control

• Study Type: Interventional
• Enrollment (Actual): 657
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elsie Taveras, MD; Phone Number: 617-726-8555; Email: elsie.taveras@mgh.harvard.edu
• Study Contact Backup: Name: Haley Farrar-Muir, MA; Phone Number: 617-643-9240; Email: hfarrar@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Parent Intervention	Behavioral: New Parent Intervention; 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.
Active Comparator: Safety Control	Behavioral: Safety Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal post-partum weight retention	Weight in kilograms	Child birth to 6-month postpartum
Maternal post-partum weight retention	Weight in kilograms	Child birth to 12-month postpartum
Maternal diet	Average weekly intake of fruits and vegetables	Baseline to 6-month postpartum
Maternal diet	Average weekly intake of fruits and vegetables	Baseline to 12-month postpartum
Maternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 6-month postpartum
Maternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 12-month postpartum
Maternal adherence to preventive health services	Number of preventative care visits attended	Baseline to 12 months post-partum
Paternal Mean Body Mass Index	Mean change in paternal BMI calculated by weight in kilograms and height in meters to report BMI in kg/m^2.	Baseline to 6-month postpartum
Paternal Mean Body Mass Index	Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2.	Baseline to 12-month postpartum
Paternal prevalence of obesity	Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.	Baseline to 12-month postpartum
Paternal adherence to preventive health services	Number of preventative care visits attended	Baseline to 12-month post-partum
Paternal diet	Average weekly intake of fruits and vegetables	Baseline to 6 months post-partum
Paternal diet	Average weekly intake of fruits and vegetables	Baseline to 12 months post-partum
Paternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 6 months post-partum
Paternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 12 months post-partum
Parental perceived stress	Perceived Stress Scale - 4-item validated scale	6 month post-partum
Prevalence of parental post-partum depression	Patient Health Questionnaire 2 (PHQ-2)	6 month post-partum
Prevalence of parental post-partum depression	Patient Health Questionnaire 2 (PHQ-2)	12 month post-partum
Prevalence of breastfeeding initiation	Self-reported response questionnaire	6 months post-partum
Infant introduction of solid foods	Self-reported response questionnaire	6 months post-partum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family enrollment in food assistance programs during intervention period	Yes/No response options for program enrollment in WIC/SNAP	Baseline to 12 months post partum
Family housing insecurity during intervention period	National Survey of American Families - 2-item validated scale	Baseline to 12 months post partum
Family food insecurity during intervention period	Hager 2-question validated scale	Baseline to 12 months post partum

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Elsie Taveras, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Social Determinants of Health; Maternal-Child Health
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: 2019P003739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No