<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477577</url>
  </required_header>
  <id_info>
    <org_study_id>2019P003739</org_study_id>
    <nct_id>NCT04477577</nct_id>
  </id_info>
  <brief_title>First Heroes: Engaging Fathers in the First 1000 Days</brief_title>
  <acronym>First Heroes</acronym>
  <official_title>First Heroes: Engaging Fathers in the First 1000 Days</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Resources and Services Administration (HRSA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The First Heroes study plans to influence weight and health trajectories, modify disease&#xD;
      risk, and improve health care services for mother-father-infant triads from racial/ethnic&#xD;
      minority and health disparity populations.&#xD;
&#xD;
      This study is a two-arm, randomized controlled trial recruiting from Massachusetts General&#xD;
      Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the&#xD;
      second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each&#xD;
      mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric&#xD;
      and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and&#xD;
      Pediatric Standard of Care + Safety Control Arm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of rapid infant weight gain</measure>
    <time_frame>Birth to child age 6 months</time_frame>
    <description>Weight-for-length z-score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of rapid infant weight gain</measure>
    <time_frame>Birth to child age 12 months</time_frame>
    <description>Weight-for-length z-score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of overweight in infants</measure>
    <time_frame>Birth to child age 12 months</time_frame>
    <description>Weight-for-length ≥97.7th percentile based on World Health Organization standards</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of overweight in infants</measure>
    <time_frame>Birth to child age 12 months</time_frame>
    <description>Weight-for-length ≥95 percentile based on Center for Disease Control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal post-partum weight retention</measure>
    <time_frame>Child birth to 6-month postpartum</time_frame>
    <description>Weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal post-partum weight retention</measure>
    <time_frame>Child birth to 12-month postpartum</time_frame>
    <description>Weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet</measure>
    <time_frame>Baseline to 6-month postpartum</time_frame>
    <description>Average weekly intake of fruits and vegetables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet</measure>
    <time_frame>Baseline to 12-month postpartum</time_frame>
    <description>Average weekly intake of fruits and vegetables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal physical activity</measure>
    <time_frame>Baseline to 6-month postpartum</time_frame>
    <description>Days per week physically active for at least 30 minutes per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal physical activity</measure>
    <time_frame>Baseline to 12-month postpartum</time_frame>
    <description>Days per week physically active for at least 30 minutes per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal adherence to preventive health services</measure>
    <time_frame>Baseline to 12 months post-partum</time_frame>
    <description>Number of preventative care visits attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal Mean Body Mass Index</measure>
    <time_frame>Baseline to 6-month postpartum</time_frame>
    <description>Mean change in paternal BMI calculated by weight in kilograms and height in meters to report BMI in kg/m^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal Mean Body Mass Index</measure>
    <time_frame>Baseline to 12-month postpartum</time_frame>
    <description>Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal prevalence of obesity</measure>
    <time_frame>Baseline to 12-month postpartum</time_frame>
    <description>Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal adherence to preventive health services</measure>
    <time_frame>Baseline to 12-month post-partum</time_frame>
    <description>Number of preventative care visits attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal diet</measure>
    <time_frame>Baseline to 6 months post-partum</time_frame>
    <description>Average weekly intake of fruits and vegetables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal diet</measure>
    <time_frame>Baseline to 12 months post-partum</time_frame>
    <description>Average weekly intake of fruits and vegetables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal physical activity</measure>
    <time_frame>Baseline to 6 months post-partum</time_frame>
    <description>Days per week physically active for at least 30 minutes per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paternal physical activity</measure>
    <time_frame>Baseline to 12 months post-partum</time_frame>
    <description>Days per week physically active for at least 30 minutes per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental endorsement of coparenting behaviors</measure>
    <time_frame>6 months post-partum</time_frame>
    <description>Co-parenting Relationship Scale - 6-item validated scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental perceived stress</measure>
    <time_frame>6 month post-partum</time_frame>
    <description>Perceived Stress Scale - 4-item validated scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of parental post-partum depression</measure>
    <time_frame>6 month post-partum</time_frame>
    <description>Patient Health Questionnaire 2 (PHQ-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of parental post-partum depression</measure>
    <time_frame>12 month post-partum</time_frame>
    <description>Patient Health Questionnaire 2 (PHQ-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of breastfeeding initiation</measure>
    <time_frame>6 months post-partum</time_frame>
    <description>Self-reported response questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant introduction of solid foods</measure>
    <time_frame>6 months post-partum</time_frame>
    <description>Self-reported response questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Family enrollment in food assistance programs during intervention period</measure>
    <time_frame>Baseline to 12 months post partum</time_frame>
    <description>Yes/No response options for program enrollment in WIC/SNAP</description>
  </other_outcome>
  <other_outcome>
    <measure>Family housing insecurity during intervention period</measure>
    <time_frame>Baseline to 12 months post partum</time_frame>
    <description>National Survey of American Families - 2-item validated scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Family food insecurity during intervention period</measure>
    <time_frame>Baseline to 12 months post partum</time_frame>
    <description>Hager 2-question validated scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">454</enrollment>
  <condition>Obesity, Childhood</condition>
  <condition>Overweight and Obesity</condition>
  <condition>Social Determinants of Health</condition>
  <condition>Physical Activity</condition>
  <condition>Feeding Behavior</condition>
  <condition>Sleep</condition>
  <condition>Diet Habit</condition>
  <arm_group>
    <arm_group_label>New Parent Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>New Parent Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>New Parent Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safety Control</intervention_name>
    <description>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.</description>
    <arm_group_label>Safety Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parental dyads must meet the following criteria:&#xD;
&#xD;
          -  Pregnant females and father of the baby, both aged ≥ 18 years&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Planned involvement during the first year of the child's life&#xD;
&#xD;
          -  Planning to receive post-partum and pediatric care for child at any pediatric practice&#xD;
             within the MassGeneral Brigham (Partners) Healthcare system&#xD;
&#xD;
          -  Ability to speak in English or Spanish&#xD;
&#xD;
          -  Capable of giving consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20&#xD;
             week ultrasound.&#xD;
&#xD;
          -  Mothers who intend on raising a child alone without any participation from the father&#xD;
             of the child.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elsie Taveras, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Elsie Taveras, MD</investigator_full_name>
    <investigator_title>Division Chief</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Social Determinants of Health</keyword>
  <keyword>Maternal-Child Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477577
org study id: 2019P003739
nct id: NCT04477577
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Prevalence of rapid infant weight gain
time frame: Birth to child age 6 months
description: Weight-for-length z-score
measure: Prevalence of rapid infant weight gain
time frame: Birth to child age 12 months
description: Weight-for-length z-score
measure: Prevalence of overweight in infants
time frame: Birth to child age 12 months
description: Weight-for-length ≥97.7th percentile based on World Health Organization standards
measure: Prevalence of overweight in infants
time frame: Birth to child age 12 months
description: Weight-for-length ≥95 percentile based on Center for Disease Control
measure: Maternal post-partum weight retention
time frame: Child birth to 6-month postpartum
description: Weight in kilograms
measure: Maternal post-partum weight retention
time frame: Child birth to 12-month postpartum
description: Weight in kilograms
measure: Maternal diet
time frame: Baseline to 6-month postpartum
description: Average weekly intake of fruits and vegetables
measure: Maternal diet
time frame: Baseline to 12-month postpartum
description: Average weekly intake of fruits and vegetables
measure: Maternal physical activity
time frame: Baseline to 6-month postpartum
description: Days per week physically active for at least 30 minutes per day
measure: Maternal physical activity
time frame: Baseline to 12-month postpartum
description: Days per week physically active for at least 30 minutes per day
measure: Maternal adherence to preventive health services
time frame: Baseline to 12 months post-partum
description: Number of preventative care visits attended
measure: Paternal Mean Body Mass Index
time frame: Baseline to 6-month postpartum
description: Mean change in paternal BMI calculated by weight in kilograms and height in meters to report BMI in kg/m^2.
measure: Paternal Mean Body Mass Index
time frame: Baseline to 12-month postpartum
description: Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2.
measure: Paternal prevalence of obesity
time frame: Baseline to 12-month postpartum
description: Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
measure: Paternal adherence to preventive health services
time frame: Baseline to 12-month post-partum
description: Number of preventative care visits attended
measure: Paternal diet
time frame: Baseline to 6 months post-partum
description: Average weekly intake of fruits and vegetables
measure: Paternal diet
time frame: Baseline to 12 months post-partum
description: Average weekly intake of fruits and vegetables
measure: Paternal physical activity
time frame: Baseline to 6 months post-partum
description: Days per week physically active for at least 30 minutes per day
measure: Paternal physical activity
time frame: Baseline to 12 months post-partum
description: Days per week physically active for at least 30 minutes per day
measure: Parental endorsement of coparenting behaviors
time frame: 6 months post-partum
description: Co-parenting Relationship Scale - 6-item validated scale
measure: Parental perceived stress
time frame: 6 month post-partum
description: Perceived Stress Scale - 4-item validated scale
measure: Prevalence of parental post-partum depression
time frame: 6 month post-partum
description: Patient Health Questionnaire 2 (PHQ-2)
measure: Prevalence of parental post-partum depression
time frame: 12 month post-partum
description: Patient Health Questionnaire 2 (PHQ-2)
measure: Prevalence of breastfeeding initiation
time frame: 6 months post-partum
description: Self-reported response questionnaire
measure: Infant introduction of solid foods
time frame: 6 months post-partum
description: Self-reported response questionnaire
measure: Family enrollment in food assistance programs during intervention period
time frame: Baseline to 12 months post partum
description: Yes/No response options for program enrollment in WIC/SNAP
measure: Family housing insecurity during intervention period
time frame: Baseline to 12 months post partum
description: National Survey of American Families - 2-item validated scale
measure: Family food insecurity during intervention period
time frame: Baseline to 12 months post partum
description: Hager 2-question validated scale
arm group label: New Parent Intervention
arm group type: Experimental
arm group label: Safety Control
arm group type: Active Comparator
intervention type: Behavioral
intervention name: New Parent Intervention
description: 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.
arm group label: New Parent Intervention
intervention type: Behavioral
intervention name: Safety Control
description: 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.
arm group label: Safety Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elsie Taveras, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Elsie Taveras, MD
investigator title: Division Chief
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity
sharing ipd: No