Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04477577
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
Time frame: Birth to child age 12 months
Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards
Time frame: Birth to child age 12 months
Weight-for-length ≥95 percentile based on Center for Disease Control
Time frame: Pre-pregnancy to 6-month postpartum
Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms.
Time frame: Prepregnancy to 12-month postpartum
Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.
Time frame: 6-month postpartum
Average weekly intake of fruits and vegetables
Time frame: 12-month postpartum
Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Time frame: 6-month postpartum
Days per week physically active for at least 30 minutes per day
Time frame: 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.
Time frame: 12 months post-partum
Endorsing PCP visit in the past year.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12-month postpartum
Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
Time frame: 12-month post-partum
Endorsement of PCP visit in the past year.
Time frame: 6 months post-partum
Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
Time frame: 12 months post-partum
Average daily intake of fruits and vegetables
Time frame: 6 months post-partum
Days per week physically active for at least 30 minutes per day
Time frame: 12 months post-partum
Participation in moderate/vigorous physical activity (Responding YES)
Time frame: 6 month post-partum
Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.
Time frame: 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)"
Time frame: 12 month post-partum
Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen
Time frame: 6 months post-partum
Self-reported response questionnaire - has infant ever been breastfed?
Time frame: 6 months post-partum
Age (months) at introduction of solid foods.
Time frame: 12 months
Responding YES to the question: "Does your family currently receive benefits from WIC?"
Time frame: 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?)
Time frame: Baseline
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)
Massachusetts General Hospital
Other
Acronym: First Heroes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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