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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

657 participants

Primary outcome timeframe

Birth to child age 6 months

Results posted on

2026-05-11

Participant Flow

Participant milestones

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

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 months

Population: 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

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 months

Defined as an increase in weight-for-age z-score of \>0.67 units from birth to 12-months of infant age

Outcome measures

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 months

Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards

Outcome measures

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 months

Weight-for-length ≥95 percentile based on Center for Disease Control

Outcome measures

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 postpartum

Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms.

Outcome measures

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 postpartum

Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.

Outcome measures

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 postpartum

Average weekly intake of fruits and vegetables

Outcome measures

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 postpartum

Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.

Outcome measures

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 postpartum

Days per week physically active for at least 30 minutes per day

Outcome measures

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 postpartum

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.

Outcome measures

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-partum

Endorsing PCP visit in the past year.

Outcome measures

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 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.

Outcome measures

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 postpartum

Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m\^2.

Outcome measures

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 postpartum

Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.

Outcome measures

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-partum

Endorsement of PCP visit in the past year.

Outcome measures

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-partum

Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.

Outcome measures

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.
Paternal Diet
54 Participants
52 Participants

SECONDARY outcome

Timeframe: 12 months post-partum

Average daily intake of fruits and vegetables

Outcome measures

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 Diet
1.7 servings/days
Standard Deviation 1.4
1.3 servings/days
Standard Deviation 1.1

SECONDARY outcome

Timeframe: 6 months post-partum

Days per week physically active for at least 30 minutes per day

Outcome measures

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.
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-partum

Participation in moderate/vigorous physical activity (Responding YES)

Outcome measures

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-partum

Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.

Outcome measures

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-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)"

Outcome measures

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-partum

Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen

Outcome measures

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-partum

Self-reported response questionnaire - has infant ever been breastfed?

Outcome measures

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-partum

Age (months) at introduction of solid foods.

Outcome measures

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 months

Responding YES to the question: "Does your family currently receive benefits from WIC?"

Outcome measures

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: Baseline

National 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

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: Baseline

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Safety Control-Mother

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New Parent Intervention-Father

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Safety Control-Father

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New Parent Intervention-Infant

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Safety Control - Infant

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Whooten

Massachusetts General Hospital

Phone: 6176434585

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place