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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
657
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.
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Number of Infants With Rapid Infant Weight Gain
Defined as an increase in weight-for-age z-score of \>0.67 units from birth to 6-months of infant age
Time frame: Birth to child age 6 months
Number of Infants With Rapid Infant Weight Gain
Defined as an increase in weight-for-age z-score of \>0.67 units from birth to 12-months of infant age
Time frame: Birth to child age 12 months
Number of Overweight Infant Participants (WHO Criteria)
Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards
Time frame: Birth to child age 12 months
Number of Overweight Infant Participants (CDC Criteria)
Weight-for-length ≥95 percentile based on Center for Disease Control
Time frame: Birth to child age 12 months
Maternal Post-partum Weight Retention
Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms.
Time frame: Pre-pregnancy to 6-month postpartum
Maternal Post-partum Weight Retention
Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.
Time frame: Prepregnancy to 12-month postpartum
Maternal Diet
Average weekly intake of fruits and vegetables
Time frame: 6-month postpartum
Maternal Diet
Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Time frame: 12-month postpartum
Maternal Physical Activity
Days per week physically active for at least 30 minutes per day
Time frame: 6-month postpartum
Maternal Physical Activity
Self-report (Yes/No) of participation in any moderate-vigorous physical activity. Percentage below represents those endorsing YES to participating in moderate vigorous physical activity.
Time frame: 12-month postpartum
Maternal Adherence to Preventive Health Services
Endorsing PCP visit in the past year.
Time frame: 12 months post-partum
Paternal Mean Body Mass Index
Mean change in paternal BMI from baseline to 6 months postpartum, calculated by weight in kilograms and height in meters to report BMI in kg/m\^2.
Time frame: 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.
Time frame: Baseline to 12-month postpartum
Paternal Prevalence of Obesity
Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
Time frame: Baseline to 12-month postpartum
Paternal Adherence to Preventive Health Services
Endorsement of PCP visit in the past year.
Time frame: 12-month post-partum
Paternal Diet
Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Time frame: 6 months post-partum
Paternal Diet
Average daily intake of fruits and vegetables
Time frame: 12 months post-partum
Paternal Physical Activity
Days per week physically active for at least 30 minutes per day
Time frame: 6 months post-partum
Paternal Physical Activity
Participation in moderate/vigorous physical activity (Responding YES)
Time frame: 12 months post-partum
Parental Perceived Stress
Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.
Time frame: 6 month post-partum
Prevalence of Parental Post-partum Depression Risk
Patient Health Questionnaire 2 (PHQ-2), scored from 0 to 6 with higher scores indicating increased risk. For purposes of this measure, 'low depression risk' included score 0-2 and 'depression risk' included score 3-6. The percentage reported below represents those with "Increased depression risk (3-6)"
Time frame: 6 month post-partum
Prevalence of Parental Post-partum Depression
Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen
Time frame: 12 month post-partum
Prevalence of Breastfeeding Initiation
Self-reported response questionnaire - has infant ever been breastfed?
Time frame: 6 months post-partum
Infant Introduction of Solid Foods
Age (months) at introduction of solid foods.
Time frame: 6 months post-partum
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