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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477577
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Elsie Taveras, MD, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Obesity, Childhood Overweight and Obesity Social Determinants of Health Physical Activity Feeding Behavior Sleep Diet Habit Behavioral: New Parent Intervention Behavioral: Safety Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: First Heroes: Engaging Fathers in the First 1000 Days
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

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.




Primary Outcome Measures :
  1. Prevalence of rapid infant weight gain [ Time Frame: Birth to child age 6 months ]
    Weight-for-length z-score

  2. Prevalence of rapid infant weight gain [ Time Frame: Birth to child age 12 months ]
    Weight-for-length z-score

  3. Prevalence of overweight in infants [ Time Frame: Birth to child age 12 months ]
    Weight-for-length ≥97.7th percentile based on World Health Organization standards

  4. Prevalence of overweight in infants [ Time Frame: Birth to child age 12 months ]
    Weight-for-length ≥95 percentile based on Center for Disease Control


Secondary Outcome Measures :
  1. Maternal post-partum weight retention [ Time Frame: Child birth to 6-month postpartum ]
    Weight in kilograms

  2. Maternal post-partum weight retention [ Time Frame: Child birth to 12-month postpartum ]
    Weight in kilograms

  3. Maternal diet [ Time Frame: Baseline to 6-month postpartum ]
    Average weekly intake of fruits and vegetables

  4. Maternal diet [ Time Frame: Baseline to 12-month postpartum ]
    Average weekly intake of fruits and vegetables

  5. Maternal physical activity [ Time Frame: Baseline to 6-month postpartum ]
    Days per week physically active for at least 30 minutes per day

  6. Maternal physical activity [ Time Frame: Baseline to 12-month postpartum ]
    Days per week physically active for at least 30 minutes per day

  7. Maternal adherence to preventive health services [ Time Frame: Baseline to 12 months post-partum ]
    Number of preventative care visits attended

  8. Paternal Mean Body Mass Index [ Time Frame: Baseline to 6-month postpartum ]
    Mean change in paternal BMI 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: Baseline to 12-month post-partum ]
    Number of preventative care visits attended

  12. Paternal diet [ Time Frame: Baseline to 6 months post-partum ]
    Average weekly intake of fruits and vegetables

  13. Paternal diet [ Time Frame: Baseline to 12 months post-partum ]
    Average weekly intake of fruits and vegetables

  14. Paternal physical activity [ Time Frame: Baseline to 6 months post-partum ]
    Days per week physically active for at least 30 minutes per day

  15. Paternal physical activity [ Time Frame: Baseline to 12 months post-partum ]
    Days per week physically active for at least 30 minutes per day

  16. Parental endorsement of coparenting behaviors [ Time Frame: 6 months post-partum ]
    Co-parenting Relationship Scale - 6-item validated scale

  17. Parental perceived stress [ Time Frame: 6 month post-partum ]
    Perceived Stress Scale - 4-item validated scale

  18. Prevalence of parental post-partum depression [ Time Frame: 6 month post-partum ]
    Patient Health Questionnaire 2 (PHQ-2)

  19. Prevalence of parental post-partum depression [ Time Frame: 12 month post-partum ]
    Patient Health Questionnaire 2 (PHQ-2)

  20. Prevalence of breastfeeding initiation [ Time Frame: 6 months post-partum ]
    Self-reported response questionnaire

  21. Infant introduction of solid foods [ Time Frame: 6 months post-partum ]
    Self-reported response questionnaire


Other Outcome Measures:
  1. Family enrollment in food assistance programs during intervention period [ Time Frame: Baseline to 12 months post partum ]
    Yes/No response options for program enrollment in WIC/SNAP

  2. Family housing insecurity during intervention period [ Time Frame: Baseline to 12 months post partum ]
    National Survey of American Families - 2-item validated scale

  3. Family food insecurity during intervention period [ Time Frame: Baseline to 12 months post partum ]
    Hager 2-question validated scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Pregnancy would be the first child for both the mother and father
  • Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system
  • Must live within a 25-mile radius of Boston
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477577


Contacts
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Contact: Elsie Taveras, MD 617-726-8555 elsie.taveras@mgh.harvard.edu
Contact: Haley Farrar-Muir, MA 617-643-9240 hfarrar@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elsie Taveras, MD    617-726-8555    elsie.taveras@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Elsie Taveras, MD Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elsie Taveras, MD, Division Chief, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04477577    
Other Study ID Numbers: 2019P003739
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elsie Taveras, MD, Massachusetts General Hospital:
Overweight
Obesity
Social Determinants of Health
Maternal-Child Health
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight