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First Heroes: Engaging Fathers in the First 1000 Days (First Heroes)

Primary Purpose

Obesity, Childhood, Overweight and Obesity, Social Determinants of Health

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New Parent Intervention
Safety Control
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring Overweight, Obesity, Social Determinants of Health, Maternal-Child Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Pregnancy would be the first child for both the mother and father
  • Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system
  • Must live within a 25-mile radius of Boston
  • 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Parent Intervention

Safety Control

Arm Description

Outcomes

Primary Outcome Measures

Prevalence of rapid infant weight gain
Weight-for-length z-score
Prevalence of rapid infant weight gain
Weight-for-length z-score
Prevalence of overweight in infants
Weight-for-length ≥97.7th percentile based on World Health Organization standards
Prevalence of overweight in infants
Weight-for-length ≥95 percentile based on Center for Disease Control

Secondary Outcome Measures

Maternal post-partum weight retention
Weight in kilograms
Maternal post-partum weight retention
Weight in kilograms
Maternal diet
Average weekly intake of fruits and vegetables
Maternal diet
Average weekly intake of fruits and vegetables
Maternal physical activity
Days per week physically active for at least 30 minutes per day
Maternal physical activity
Days per week physically active for at least 30 minutes per day
Maternal adherence to preventive health services
Number of preventative care visits attended
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.
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.
Paternal prevalence of obesity
Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
Paternal adherence to preventive health services
Number of preventative care visits attended
Paternal diet
Average weekly intake of fruits and vegetables
Paternal diet
Average weekly intake of fruits and vegetables
Paternal physical activity
Days per week physically active for at least 30 minutes per day
Paternal physical activity
Days per week physically active for at least 30 minutes per day
Parental endorsement of coparenting behaviors
Co-parenting Relationship Scale - 6-item validated scale
Parental perceived stress
Perceived Stress Scale - 4-item validated scale
Prevalence of parental post-partum depression
Patient Health Questionnaire 2 (PHQ-2)
Prevalence of parental post-partum depression
Patient Health Questionnaire 2 (PHQ-2)
Prevalence of breastfeeding initiation
Self-reported response questionnaire
Infant introduction of solid foods
Self-reported response questionnaire

Full Information

First Posted
July 8, 2020
Last Updated
March 8, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT04477577
Brief Title
First Heroes: Engaging Fathers in the First 1000 Days
Acronym
First Heroes
Official Title
First Heroes: Engaging Fathers in the First 1000 Days
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Health Resources and Services Administration (HRSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsie Taveras, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35624421
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.
Results Reference
derived

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First Heroes: Engaging Fathers in the First 1000 Days

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