Diet Habit, Feeding Behavior, Obesity, Childhood, Overweight and Obesity, Physical Activity, Sleep, Social Determinants of Health
Conditions
Keywords
Overweight, Obesity, Social Determinants of Health, Maternal-Child Health
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.
Interventions
BEHAVIORALNew 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.
BEHAVIORALSafety 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.
Sponsors
Massachusetts General Hospital
Health Resources and Services Administration (HRSA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants With Rapid Infant Weight Gain | Birth to child age 6 months | Defined as an increase in weight-for-age z-score of \>0.67 units from birth to 6-months of infant age |
| Number of Overweight Infant Participants (WHO Criteria) | Birth to child age 12 months | Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards |
| Number of Overweight Infant Participants (CDC Criteria) | Birth to child age 12 months | Weight-for-length ≥95 percentile based on Center for Disease Control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Post-partum Weight Retention | Pre-pregnancy to 6-month postpartum | Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms. |
| Maternal Diet | 6-month postpartum | Average weekly intake of fruits and vegetables |
| Maternal Physical Activity | 6-month postpartum | Days per week physically active for at least 30 minutes per day |
| Maternal Adherence to Preventive Health Services | 12 months post-partum | Endorsing PCP visit in the past year. |
| Paternal Mean Body Mass Index | Baseline to 6-month postpartum | 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. |
| 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 | 12-month post-partum | Endorsement of PCP visit in the past year. |
| Paternal Diet | 6 months post-partum | Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often. |
| Paternal Physical Activity | 6 months post-partum | Days per week physically active for at least 30 minutes per day |
| Parental Perceived Stress | 6 month post-partum | Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress. |
| Prevalence of Parental Post-partum Depression Risk | 6 month post-partum | 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)" |
| Prevalence of Parental Post-partum Depression | 12 month post-partum | Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen |
| Prevalence of Breastfeeding Initiation | 6 months post-partum | Self-reported response questionnaire - has infant ever been breastfed? |
| Infant Introduction of Solid Foods | 6 months post-partum | Age (months) at introduction of solid foods. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElsie Taveras, MD
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 101 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 454 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 195 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 101 Participants |
| Race (NIH/OMB) White | 229 Participants |
| Region of Enrollment United States | 113 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 114 | 0 / 113 | 0 / 114 | 0 / 93 | 0 / 101 |
| other Total, other adverse events | 0 / 113 | 0 / 114 | 0 / 113 | 0 / 114 | 0 / 93 | 0 / 101 |
| serious Total, serious adverse events | 0 / 113 | 0 / 114 | 0 / 113 | 0 / 114 | 0 / 93 | 0 / 101 |
Outcome results
None listed