Obesity, ChildhoodFirst HeroesNCT04477577

First Heroes: Engaging Fathers in the First 1000 Days

A study testing New Parent Intervention in people with Obesity, Childhood and Overweight and Obesity, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Childhood, Overweight and Obesity, Social Determinants of Health
What is being tested?: New Parent Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 657 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2020to 30 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Parental dyads must meet the following criteria:
Pregnant females and father of the baby, both aged ≥ 18 years
Singleton pregnancy
Planned involvement during the first year of the child's life
Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system
Ability to speak in English or Spanish
Capable of giving consent

Who cannot join

Dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20 week ultrasound.
Mothers who intend on raising a child alone without any participation from the father of the child.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.

Conditions: Obesity, Childhood, Overweight and Obesity, Social Determinants of Health, Physical Activity, Feeding Behavior, Sleep
Being tested: New Parent Intervention, Safety Control
Keywords: Overweight, Obesity, Social Determinants of Health, Maternal-Child Health
Medical subject headings: Pediatric Obesity, Overweight, Obesity, Motor Activity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New Parent InterventionBehavioural
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 ControlBehavioural
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.

Study groups in NCT04477577
Study group	Role	What they receive
New Parent Intervention	Experimental	Not described Receives: Behavioral: New Parent Intervention
Safety Control	Active comparator	Not described Receives: Behavioral: Safety Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Infants With Rapid Infant Weight Gain
Defined as an increase in weight-for-age z-score of >0.67 units from birth to 6-months of infant age
Measured: Birth to child age 6 months
Number of Infants With Rapid Infant Weight Gain
Defined as an increase in weight-for-age z-score of >0.67 units from birth to 12-months of infant age
Measured: Birth to child age 12 months
Number of Overweight Infant Participants (WHO Criteria)
Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards
Measured: Birth to child age 12 months
Number of Overweight Infant Participants (CDC Criteria)
Weight-for-length ≥95 percentile based on Center for Disease Control
Measured: Birth to child age 12 months

Secondary outcomes (20)

Maternal Post-partum Weight Retention
Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms.
Measured: Pre-pregnancy to 6-month postpartum
Maternal Post-partum Weight Retention
Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.
Measured: Prepregnancy to 12-month postpartum
Maternal Diet
Average weekly intake of fruits and vegetables
Measured: 6-month postpartum
Maternal Diet
Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Measured: 12-month postpartum
Maternal Physical Activity
Days per week physically active for at least 30 minutes per day
Measured: 6-month postpartum
Maternal Physical Activity
Self-report (Yes/No) of participation in any moderate-vigorous physical activity. Percentage below represents those endorsing YES to participating in moderate vigorous physical activity.
Measured: 12-month postpartum
Maternal Adherence to Preventive Health Services
Endorsing PCP visit in the past year.
Measured: 12 months post-partum
Paternal Mean Body Mass Index
Mean change in paternal BMI from baseline to 6 months postpartum, calculated by weight in kilograms and height in meters to report BMI in kg/m^2.
Measured: Baseline to 6-month postpartum
Paternal Mean Body Mass Index
Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2.
Measured: Baseline to 12-month postpartum
Paternal Prevalence of Obesity
Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
Measured: Baseline to 12-month postpartum
Paternal Adherence to Preventive Health Services
Endorsement of PCP visit in the past year.
Measured: 12-month post-partum
Paternal Diet
Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Measured: 6 months post-partum
Paternal Diet
Average daily intake of fruits and vegetables
Measured: 12 months post-partum
Paternal Physical Activity
Days per week physically active for at least 30 minutes per day
Measured: 6 months post-partum
Paternal Physical Activity
Participation in moderate/vigorous physical activity (Responding YES)
Measured: 12 months post-partum
Parental Perceived Stress
Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.
Measured: 6 month post-partum
Prevalence of Parental Post-partum Depression Risk
Patient Health Questionnaire 2 (PHQ-2), scored from 0 to 6 with higher scores indicating increased risk. For purposes of this measure, 'low depression risk' included score 0-2 and 'depression risk' included score 3-6.
The percentage reported below represents those with "Increased depression risk (3-6)"
Measured: 6 month post-partum
Prevalence of Parental Post-partum Depression
Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen
Measured: 12 month post-partum
Prevalence of Breastfeeding Initiation
Self-reported response questionnaire - has infant ever been breastfed?
Measured: 6 months post-partum
Infant Introduction of Solid Foods
Age (months) at introduction of solid foods.
Measured: 6 months post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202030 Nov 2023

First posted20 Jul 2020
Study start4 Aug 2020
Primary completion30 Nov 2023
Study completion30 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 657 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04477577
Sponsor's protocol ID: 2019P003739
Acronym: First Heroes
Status last verified: Apr 2026
First submitted: 8 Jul 2020
Last updated: 11 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Silver SR, Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. BMC Pregnancy Childbirth. 2022 May 27;22(1):443. doi: 10.1186/s12884-022-04759-z.
PubMed 35624421
Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial. Contemp Clin Trials. 2021 Feb;101:106253. doi: 10.1016/j.cct.2020.106253. Epub 2020 Dec 17.
PubMed 33340750
Whooten RC, Kotelchuck M, Gonzalez AVC, Johnson N, Kwete G, Luo M, Muir HF, Barth EA, Smith N, Taveras EM. Expectant fathers' health behaviors, infant care intentions, and social-emotional wellbeing in the perinatal period: A latent class analysis and comparison to mothers. Prev Med Rep. 2023 Aug 26;36:102375. doi: 10.1016/j.pmedr.2023.102375. eCollection 2023 Dec.
PubMed 37719794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity, Childhood trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First Heroes: Engaging Fathers in the First 1000 Days
ClinicalTrials.gov ID: NCT04477577
Acronym / sponsor ID: First Heroes / 2019P003739
Conditions: Obesity, Childhood, Overweight and Obesity, Social Determinants of Health, Physical Activity, Feeding Behavior, Sleep
Keywords: Overweight, Obesity, Social Determinants of Health, Maternal-Child Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 657 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Health Resources and Services Administration (HRSA)
Study start: 4 Aug 2020 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 30 Nov 2023 (actual)
First posted: 20 Jul 2020 (actual)
Results: Posted 11 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
New Parent Intervention	Experimental	Behavioral: New Parent Intervention
Safety Control	Active comparator	Behavioral: Safety Control

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Parental dyads must meet the following criteria:
Pregnant females and father of the baby, both aged ≥ 18 years
Singleton pregnancy
Planned involvement during the first year of the child's life
Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system

Key exclusion criteria (2 listed)

Dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20 week ultrasound.
Mothers who intend on raising a child alone without any participation from the father of the child.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
New Parent InterventionThis 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.	Behavioural	New Parent Intervention
Safety ControlThis arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials.	Behavioural	Safety Control

Primary outcome

Number of Infants With Rapid Infant Weight Gain
Time frame: Birth to child age 6 months
Defined as an increase in weight-for-age z-score of >0.67 units from birth to 6-months of infant age
Number of Infants With Rapid Infant Weight Gain
Time frame: 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
Number of Overweight Infant Participants (WHO Criteria)
Time frame: Birth to child age 12 months
Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards
Number of Overweight Infant Participants (CDC Criteria)
Time frame: Birth to child age 12 months
Weight-for-length ≥95 percentile based on Center for Disease Control

20 secondary outcomes

Maternal Post-partum Weight Retention
Time frame: Pre-pregnancy to 6-month postpartum
Maternal Post-partum Weight Retention
Time frame: Prepregnancy to 12-month postpartum
Maternal Diet
Time frame: 6-month postpartum
Maternal Diet
Time frame: 12-month postpartum
Maternal Physical Activity
Time frame: 6-month postpartum
Maternal Physical Activity
Time frame: 12-month postpartum
Maternal Adherence to Preventive Health Services
Time frame: 12 months post-partum
Paternal Mean Body Mass Index
Time frame: Baseline to 6-month postpartum
Paternal Mean Body Mass Index
Time frame: Baseline to 12-month postpartum
Paternal Prevalence of Obesity
Time frame: Baseline to 12-month postpartum
Paternal Adherence to Preventive Health Services
Time frame: 12-month post-partum
Paternal Diet
Time frame: 6 months post-partum
Paternal Diet
Time frame: 12 months post-partum
Paternal Physical Activity
Time frame: 6 months post-partum
Paternal Physical Activity
Time frame: 12 months post-partum
Parental Perceived Stress
Time frame: 6 month post-partum
Prevalence of Parental Post-partum Depression Risk
Time frame: 6 month post-partum
Prevalence of Parental Post-partum Depression
Time frame: 12 month post-partum
Prevalence of Breastfeeding Initiation
Time frame: 6 months post-partum
Infant Introduction of Solid Foods
Time frame: 6 months post-partum

Results and safety

Results posted to the registry on 11 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Parent Intervention - Mothers	113	84
Safety Control - Mothers	114	87
New Parent Intervention - Fathers	113	74
Safety Control - Fathers	114	76
New Parent Intervention - Infants	93	79
Safety Control - Infants	101	88

Primary outcome: Number of Infants With Rapid Infant Weight Gain

Time frame: Birth to child age 6 months. Count of participants. Unit: Participants

Measure	New Parent Intervention - Infant n = 79	Safety Control- Infant n = 88
Value	12	27

Population analysed: Based on those with complete growth data at birth and 6-months.

Primary outcome: Number of Infants With Rapid Infant Weight Gain

Time frame: Birth to child age 12 months. Count of participants. Unit: Participants

Measure	New Parent Intervention- Infant n = 78	Safety Control- Infant n = 88
Value	21	39

Primary outcome: Number of Overweight Infant Participants (WHO Criteria)

Time frame: Birth to child age 12 months. Count of participants. Unit: Participants

Measure	New Parent Intervention - Infant n = 79	Safety Control - Infant n = 88
Value	2	3

Primary outcome: Number of Overweight Infant Participants (CDC Criteria)

Time frame: Birth to child age 12 months. Count of participants. Unit: Participants

Measure	New Parent Intervention- Infant n = 78	Safety Control- Infant n = 88
Value	4	8

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from baseline survey (2nd trimester of pregnancy) to final survey (infant age 12 months); approximately 15 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Parent Intervention-Mother	0 of 113 (0%)	0 of 113 (0%)	0 of 113
Safety Control-Mother	0 of 114 (0%)	0 of 114 (0%)	0 of 114
New Parent Intervention-Father	0 of 113 (0%)	0 of 113 (0%)	0 of 113
Safety Control-Father	0 of 114 (0%)	0 of 114 (0%)	0 of 114
New Parent Intervention-Infant	0 of 93 (0%)	0 of 93 (0%)	0 of 93
Safety Control - Infant	0 of 101 (0%)	0 of 101 (0%)	0 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35624421Silver SR, Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. BMC Pregnancy Childbirth. 2022 May 27;22(1):443. doi: 10.1186/s12884-022-04759-z.
Background: PubMed 33340750Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial. Contemp Clin Trials. 2021 Feb;101:106253. doi: 10.1016/j.cct.2020.106253. Epub 2020 Dec 17.
Background: PubMed 37719794Whooten RC, Kotelchuck M, Gonzalez AVC, Johnson N, Kwete G, Luo M, Muir HF, Barth EA, Smith N, Taveras EM. Expectant fathers' health behaviors, infant care intentions, and social-emotional wellbeing in the perinatal period: A latent class analysis and comparison to mothers. Prev Med Rep. 2023 Aug 26;36:102375. doi: 10.1016/j.pmedr.2023.102375. eCollection 2023 Dec.
Individual participant dataSharing planned: No

Related trials for Obesity, Childhood

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elsie Taveras, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New Parent Intervention in people with Obesity, Childhood and Overweight and Obesity, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Infants With Rapid Infant Weight Gain (time frame: Birth to child age 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477577, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.