Clinical trial NCT04477577: First Heroes: Engaging Fathers in the First 1000 Days
Official title: First Heroes: Engaging Fathers in the First 1000 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Overweight and Obesity
Social Determinants of Health
Physical Activity
Feeding Behavior
Sleep
Diet Habit
Keywords: Overweight
Obesity
Social Determinants of Health
Maternal-Child Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2020-07-20
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of rapid infant weight gain
timeFrame: Birth to child age 6 months
measure: Prevalence of rapid infant weight gain
timeFrame: Birth to child age 12 months
measure: Prevalence of overweight in infants
timeFrame: Birth to child age 12 months
measure: Prevalence of overweight in infants
timeFrame: Birth to child age 12 months
Secondary outcomes:
measure: Maternal post-partum weight retention
timeFrame: Child birth to 6-month postpartum
measure: Maternal post-partum weight retention
timeFrame: Child birth to 12-month postpartum
measure: Maternal diet
timeFrame: Baseline to 6-month postpartum
measure: Maternal diet
timeFrame: Baseline to 12-month postpartum
measure: Maternal physical activity
timeFrame: Baseline to 6-month postpartum
measure: Maternal physical activity
timeFrame: Baseline to 12-month postpartum
measure: Maternal adherence to preventive health services
timeFrame: Baseline to 12 months post-partum
measure: Paternal Mean Body Mass Index
timeFrame: Baseline to 6-month postpartum
measure: Paternal Mean Body Mass Index
timeFrame: Baseline to 12-month postpartum
measure: Paternal prevalence of obesity
timeFrame: Baseline to 12-month postpartum
measure: Paternal adherence to preventive health services
timeFrame: Baseline to 12-month post-partum
measure: Paternal diet
timeFrame: Baseline to 6 months post-partum
measure: Paternal diet
timeFrame: Baseline to 12 months post-partum
measure: Paternal physical activity
timeFrame: Baseline to 6 months post-partum
measure: Paternal physical activity
timeFrame: Baseline to 12 months post-partum
measure: Parental perceived stress
timeFrame: 6 month post-partum
measure: Prevalence of parental post-partum depression
timeFrame: 6 month post-partum
measure: Prevalence of parental post-partum depression
timeFrame: 12 month post-partum
measure: Prevalence of breastfeeding initiation
timeFrame: 6 months post-partum
measure: Infant introduction of solid foods
timeFrame: 6 months post-partum
Other outcomes:
measure: Family enrollment in food assistance programs during intervention period
timeFrame: Baseline to 12 months post partum
measure: Family housing insecurity during intervention period
timeFrame: Baseline to 12 months post partum
measure: Family food insecurity during intervention period
timeFrame: Baseline to 12 months post partum
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elsie Taveras, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.