Trial Outcomes & Findings for First Heroes: Engaging Fathers in the First 1000 Days (NCT NCT04477577)
NCT ID: NCT04477577
Last Updated: 2026-05-11
Results Overview
Defined as an increase in weight-for-age z-score of \>0.67 units from birth to 6-months of infant age
COMPLETED
NA
657 participants
Birth to child age 6 months
2026-05-11
Participant Flow
Participant milestones
| Measure |
New Parent Intervention - Mothers
New Parent Intervention - Mothers: 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.
|
Safety Control - Mothers
Safety Control - Mothers: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
New Parent Intervention - Infants
New Parent Intervention - Infants: 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
|
Safety Control - Infants
Safety Control - Infants: 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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
113
|
114
|
113
|
114
|
93
|
101
|
|
Overall Study
COMPLETED
|
84
|
87
|
74
|
76
|
79
|
88
|
|
Overall Study
NOT COMPLETED
|
29
|
27
|
39
|
38
|
14
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First Heroes: Engaging Fathers in the First 1000 Days
Baseline characteristics by cohort
| Measure |
New Parent Intervention - Mothers
n=113 Participants
New Parent Intervention - Mothers: 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.
|
Safety Control - Mothers
n=114 Participants
Safety Control- Mothers: 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.
|
New Parent Intervention - Fathers
n=113 Participants
New Parent Intervention - Fathers: 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.
|
Safety Control - Fathers
n=114 Participants
Safety Control- Fathers: 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.
|
New Parent Intervention - Infants
n=93 Participants
New Parent Intervention - Infants: 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.
|
Safety Control - Infants
n=101 Participants
Safety Control- Infants: 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.
|
Total
n=648 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
93 Participants
n=97 Participants
|
101 Participants
n=488 Participants
|
194 Participants
n=825 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=44 Participants
|
114 Participants
n=10 Participants
|
113 Participants
n=30 Participants
|
114 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
454 Participants
n=825 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=44 Participants
|
114 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
49 Participants
n=97 Participants
|
53 Participants
n=488 Participants
|
329 Participants
n=825 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
113 Participants
n=30 Participants
|
114 Participants
n=1054 Participants
|
44 Participants
n=97 Participants
|
48 Participants
n=488 Participants
|
319 Participants
n=825 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=44 Participants
|
37 Participants
n=10 Participants
|
26 Participants
n=30 Participants
|
28 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
132 Participants
n=825 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=44 Participants
|
77 Participants
n=10 Participants
|
87 Participants
n=30 Participants
|
85 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
321 Participants
n=825 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=1054 Participants
|
93 Participants
n=97 Participants
|
101 Participants
n=488 Participants
|
195 Participants
n=825 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=44 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=30 Participants
|
8 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
42 Participants
n=825 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
1 Participants
n=825 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=44 Participants
|
21 Participants
n=10 Participants
|
13 Participants
n=30 Participants
|
24 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
73 Participants
n=825 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=44 Participants
|
60 Participants
n=10 Participants
|
62 Participants
n=30 Participants
|
54 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
229 Participants
n=825 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=44 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
15 Participants
n=825 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=44 Participants
|
23 Participants
n=10 Participants
|
21 Participants
n=30 Participants
|
24 Participants
n=1054 Participants
|
93 Participants
n=97 Participants
|
101 Participants
n=488 Participants
|
288 Participants
n=825 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=44 Participants
|
114 participants
n=10 Participants
|
113 participants
n=30 Participants
|
114 participants
n=1054 Participants
|
93 participants
n=97 Participants
|
101 participants
n=488 Participants
|
648 participants
n=825 Participants
|
PRIMARY outcome
Timeframe: Birth to child age 6 monthsPopulation: Based on those with complete growth data at birth and 6-months.
Defined as an increase in weight-for-age z-score of \>0.67 units from birth to 6-months of infant age
Outcome measures
| Measure |
New Parent Intervention - Infant
n=79 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=88 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Number of Infants With Rapid Infant Weight Gain
|
12 Participants
|
27 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Birth to child age 12 monthsDefined as an increase in weight-for-age z-score of \>0.67 units from birth to 12-months of infant age
Outcome measures
| Measure |
New Parent Intervention - Infant
n=78 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=88 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Number of Infants With Rapid Infant Weight Gain
|
21 Participants
|
39 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Birth to child age 12 monthsWeight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards
Outcome measures
| Measure |
New Parent Intervention - Infant
n=79 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=88 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Number of Overweight Infant Participants (WHO Criteria)
|
2 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Birth to child age 12 monthsWeight-for-length ≥95 percentile based on Center for Disease Control
Outcome measures
| Measure |
New Parent Intervention - Infant
n=78 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=88 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Number of Overweight Infant Participants (CDC Criteria)
|
4 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-pregnancy to 6-month postpartumDifference between 6-month postpartum weight and pre-pregnancy weight in kilograms.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=74 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=83 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Post-partum Weight Retention
|
3.23 kg
Standard Deviation 13.25
|
3.70 kg
Standard Deviation 9.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Prepregnancy to 12-month postpartumDifference between 12-month postpartum weight and pre-pregnancy weight in kilograms.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=74 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=87 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Post-partum Weight Retention
|
2.01 kg
Standard Deviation 8.24
|
2.99 kg
Standard Deviation 6.31
|
—
|
—
|
SECONDARY outcome
Timeframe: 6-month postpartumAverage weekly intake of fruits and vegetables
Outcome measures
| Measure |
New Parent Intervention - Infant
n=84 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=87 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Diet
|
1.8 servings/day
Standard Deviation 1.5
|
1.9 servings/day
Standard Deviation 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-month postpartumFrequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=75 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=89 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Diet
|
54 Participants
|
71 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6-month postpartumDays per week physically active for at least 30 minutes per day
Outcome measures
| Measure |
New Parent Intervention - Infant
n=85 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=90 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Physical Activity
|
2.25 days/week
Standard Deviation 1.06
|
2.59 days/week
Standard Deviation 1.46
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-month postpartumSelf-report (Yes/No) of participation in any moderate-vigorous physical activity. Percentage below represents those endorsing YES to participating in moderate vigorous physical activity.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=82 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=86 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Physical Activity
|
43 Participants
|
47 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post-partumEndorsing PCP visit in the past year.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=75 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=89 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Maternal Adherence to Preventive Health Services
|
43 Participants
|
42 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6-month postpartumMean 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.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=74 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=73 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Paternal Mean Body Mass Index
|
-0.14 kg/m^2
Standard Deviation 2.48
|
0.82 kg/m^2
Standard Deviation 3.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12-month postpartumMean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m\^2.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=65 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=71 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Paternal Mean Body Mass Index
|
0.16 kg/m^2
Standard Deviation 1.88
|
0.60 kg/m^2
Standard Deviation 3.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12-month postpartumPrevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=67 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=74 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Paternal Prevalence of Obesity
|
15 Participants
|
24 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-month post-partumEndorsement of PCP visit in the past year.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=66 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=73 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Paternal Adherence to Preventive Health Services
|
31 Participants
|
32 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post-partumFrequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=74 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=76 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
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|---|---|---|---|---|
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Paternal Diet
|
54 Participants
|
52 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post-partumAverage daily intake of fruits and vegetables
Outcome measures
| Measure |
New Parent Intervention - Infant
n=66 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=73 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
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|---|---|---|---|---|
|
Paternal Diet
|
1.7 servings/days
Standard Deviation 1.4
|
1.3 servings/days
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post-partumDays per week physically active for at least 30 minutes per day
Outcome measures
| Measure |
New Parent Intervention - Infant
n=74 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=76 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
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|---|---|---|---|---|
|
Paternal Physical Activity
|
2.78 days/week
Standard Deviation 1.48
|
3.14 days/week
Standard Deviation 1.88
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post-partumParticipation in moderate/vigorous physical activity (Responding YES)
Outcome measures
| Measure |
New Parent Intervention - Infant
n=66 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=73 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Paternal Physical Activity
|
43 Participants
|
47 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 month post-partumPerceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=85 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=90 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=75 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=79 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Parental Perceived Stress
|
4.74 score on a scale
Standard Deviation 2.96
|
4.52 score on a scale
Standard Deviation 3.02
|
4.75 score on a scale
Standard Deviation 2.88
|
4.42 score on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 6 month post-partumPatient 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)"
Outcome measures
| Measure |
New Parent Intervention - Infant
n=85 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=90 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=75 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=79 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Prevalence of Parental Post-partum Depression Risk
|
10 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 month post-partumPatient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen
Outcome measures
| Measure |
New Parent Intervention - Infant
n=75 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=89 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=66 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=73 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Prevalence of Parental Post-partum Depression
|
3 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months post-partumSelf-reported response questionnaire - has infant ever been breastfed?
Outcome measures
| Measure |
New Parent Intervention - Infant
n=91 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=95 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=82 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=86 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Prevalence of Breastfeeding Initiation
|
84 Participants
|
90 Participants
|
75 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: 6 months post-partumAge (months) at introduction of solid foods.
Outcome measures
| Measure |
New Parent Intervention - Infant
n=91 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=95 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=82 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=86 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Infant Introduction of Solid Foods
|
4.7 age (months)
Standard Deviation 0.8
|
4.5 age (months)
Standard Deviation 0.6
|
4.7 age (months)
Standard Deviation 0.9
|
4.5 age (months)
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsResponding YES to the question: "Does your family currently receive benefits from WIC?"
Outcome measures
| Measure |
New Parent Intervention - Infant
n=85 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=90 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=77 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=91 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Family Enrollment in Food Assistance Programs
|
16 Participants
|
22 Participants
|
12 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineNational Survey of American Families - 2-item validated scale, response of YES to either question was determined positive screen ((1) During the last 12 months, was there a time when you and your family were not able to pay your mortgage, rent or utility bills? (2) During the last 12 months, did you or your children move in with other people even for a little while because you could not afford to pay your mortgage, rent or utility bills?)
Outcome measures
| Measure |
New Parent Intervention - Infant
n=93 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=101 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=93 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=101 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Family Housing Insecurity During Intervention Period
|
6 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Measured at baseline only; not follow-up.
Hager 2-question validated scale - responded YES to either of two questions relating to household food insecurity ((1) Within the past 12 months we worried whether our food would run out before we got money to buy more (2) Within the past 12 months the food we bought just didn't last and we didn't have money to get more)
Outcome measures
| Measure |
New Parent Intervention - Infant
n=93 Participants
New Parent Intervention - Infant: 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.
|
Safety Control- Infant
n=101 Participants
Safety Control- Infant: 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.
|
New Parent Intervention - Fathers
n=93 Participants
New Parent Intervention - Fathers: 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
|
Safety Control - Fathers
n=101 Participants
Safety Control- Fathers: 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.
|
|---|---|---|---|---|
|
Family Food Insecurity During Intervention Period
|
6 Participants
|
10 Participants
|
6 Participants
|
10 Participants
|
Adverse Events
New Parent Intervention-Mother
Safety Control-Mother
New Parent Intervention-Father
Safety Control-Father
New Parent Intervention-Infant
Safety Control - Infant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place