First Heroes: Engaging Fathers in the First 1000 Days

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04477577

Collaborator

Health Resources and Services Administration (HRSA) (U.S. Fed)

500

Enrollment

Location

Arms

22.8

Anticipated Duration (Months)

21.9

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 4, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 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.

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

Prevalence of rapid infant weight gain [Birth to child age 6 months]
Weight-for-length z-score
Prevalence of rapid infant weight gain [Birth to child age 12 months]
Weight-for-length z-score
Prevalence of overweight in infants [Birth to child age 12 months]
Weight-for-length ≥97.7th percentile based on World Health Organization standards
Prevalence of overweight in infants [Birth to child age 12 months]
Weight-for-length ≥95 percentile based on Center for Disease Control

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.