First Heroes: Engaging Fathers in the First 1000 Days

Physical Activity Clinical Trial

— First Heroes  

Official title:

First Heroes: Engaging Fathers in the First 1000 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477577
• Other study ID #: 2019P003739
• Status: Completed
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parental dyads must meet the following criteria:

• Pregnant females and father of the baby, both aged = 18 years

• Singleton pregnancy

• Planned involvement during the first year of the child's life

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

• Ability to speak in English or Spanish

• Capable of giving consent

Exclusion Criteria:

• Dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20 week ultrasound.

• Mothers who intend on raising a child alone without any participation from the father of the child.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• New Parent Intervention
This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach.
• Safety Control
This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family enrollment in food assistance programs during intervention period	Yes/No response options for program enrollment in WIC/SNAP	Baseline to 12 months post partum
Other	Family housing insecurity during intervention period	National Survey of American Families - 2-item validated scale	Baseline to 12 months post partum
Other	Family food insecurity during intervention period	Hager 2-question validated scale	Baseline to 12 months post partum
Primary	Prevalence of rapid infant weight gain	Weight-for-length z-score	Birth to child age 6 months
Primary	Prevalence of rapid infant weight gain	Weight-for-length z-score	Birth to child age 12 months
Primary	Prevalence of overweight in infants	Weight-for-length =97.7th percentile based on World Health Organization standards	Birth to child age 12 months
Primary	Prevalence of overweight in infants	Weight-for-length =95 percentile based on Center for Disease Control	Birth to child age 12 months
Secondary	Maternal post-partum weight retention	Weight in kilograms	Child birth to 6-month postpartum
Secondary	Maternal post-partum weight retention	Weight in kilograms	Child birth to 12-month postpartum
Secondary	Maternal diet	Average weekly intake of fruits and vegetables	Baseline to 6-month postpartum
Secondary	Maternal diet	Average weekly intake of fruits and vegetables	Baseline to 12-month postpartum
Secondary	Maternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 6-month postpartum
Secondary	Maternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 12-month postpartum
Secondary	Maternal adherence to preventive health services	Number of preventative care visits attended	Baseline to 12 months post-partum
Secondary	Paternal Mean Body Mass Index	Mean change in paternal BMI calculated by weight in kilograms and height in meters to report BMI in kg/m^2.	Baseline to 6-month postpartum
Secondary	Paternal Mean Body Mass Index	Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2.	Baseline to 12-month postpartum
Secondary	Paternal prevalence of obesity	Prevalence of BMI=30 kg/m2 calculated by weight in kilograms and height in meters.	Baseline to 12-month postpartum
Secondary	Paternal adherence to preventive health services	Number of preventative care visits attended	Baseline to 12-month post-partum
Secondary	Paternal diet	Average weekly intake of fruits and vegetables	Baseline to 6 months post-partum
Secondary	Paternal diet	Average weekly intake of fruits and vegetables	Baseline to 12 months post-partum
Secondary	Paternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 6 months post-partum
Secondary	Paternal physical activity	Days per week physically active for at least 30 minutes per day	Baseline to 12 months post-partum
Secondary	Parental perceived stress	Perceived Stress Scale - 4-item validated scale	6 month post-partum
Secondary	Prevalence of parental post-partum depression	Patient Health Questionnaire 2 (PHQ-2)	6 month post-partum
Secondary	Prevalence of parental post-partum depression	Patient Health Questionnaire 2 (PHQ-2)	12 month post-partum
Secondary	Prevalence of breastfeeding initiation	Self-reported response questionnaire	6 months post-partum
Secondary	Infant introduction of solid foods	Self-reported response questionnaire	6 months post-partum