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

• ClinicalTrials.gov Identifier: NCT04477577
• Recruitment Status: Recruiting
• First Posted: July 20, 2020
• Last Update Posted: April 6, 2022
• Sponsor: Massachusetts General Hospital
• Collaborator: Health Resources and Services Administration (HRSA)
• Information provided by (Responsible Party): Elsie Taveras, MD, Massachusetts General Hospital

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

• Principal Investigator: Elsie Taveras, MD; Massachusetts General Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Elsie Taveras, MD, Division Chief, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04477577
• Other Study ID Numbers: 2019P003739
• First Posted: July 20, 2020
• Last Update Posted: April 6, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Obesity; Pediatric Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight