First Heroes: Engaging Fathers in the First 1000 Days

Study Overview
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Brief Summary
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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.

Official Title
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First Heroes: Engaging Fathers in the First 1000 Days

Conditions
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Sleep, Obesity, Childhood, Overweight and Obesity, Social Determinants of Health, Physical Activity, Feeding Behavior, Diet Habit

Intervention / Treatment
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* Behavioral: New Parent Intervention
* Behavioral: Safety Control


Participation Criteria
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Eligibility Criteria
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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 Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Parent Intervention<br> | Behavioral: New Parent Intervention<br>* 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.<br>|
| Active Comparator: Safety Control<br> | Behavioral: Safety Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Social Determinants of Health, Maternal-Child Health