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The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life

The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03191591
Enrollment
1645
Registered
2017-06-19
Start date
2016-08-09
Completion date
2021-03-18
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Overweight, Obesity, Maternal-child, Social Determinants of Health

Brief summary

The First 1000 Days (conception to age 2) is a crucial period for the development and prevention of obesity and its adverse consequences in mother-child pairs and their families. The overall aim of the First 1000 Days program is to work across early-life systems to prevent obesity, promote healthy routines and behaviors, address social determinants of health, and reduce health disparities among vulnerable children and families at community health centers in the Boston, MA area. The study aims to simultaneously implement and evaluate an obesity prevention program across early life systems to reduce the prevalence of obesity risk factors within racial/ethnic minority families, close the gap in maternal-child health disparities, and assess and address social determinants of health.

Interventions

BEHAVIORALFirst 1,000 Days Program Site

Program components will include 1) Enhancements to and improved use of electronic health records to improve the quality of preventive services and screening for social determinants of health; 2) Staff and provider training; 3) Consistent behavior change messaging; 4) Patient education via print materials, text messaging and short videos; and 5) Strengthening the integration of clinical and public health services to support behavior change and address social determinants of health.

Sponsors

The Boston Foundation
CollaboratorUNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The First 1,000 Days program is a systems-level program that will reach all expectant mothers and families with 0-2 year olds receiving care at Boston-area community health centers. Mothers and infants at two similar non-intervention Boston-area health centers will be used as a comparison sample. Maternal and infant obesity-related clinical information is routinely recorded during patient visits in the EHR used at both the intervention and comparison sites. Sample size enrollment reflects maternal-infant dyads.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All pregnant women receiving prenatal care at select community health centers in the Boston, MA area * All families of children aged 0-2 years receiving pediatric care at select community health centers in the Boston, MA area

Design outcomes

Primary

MeasureTime frameDescription
Infant Weight-for-Length Z-ScoreChild age 6 monthsAge- and sex-specific weight-for-length z-score
Maternal Gestational Weight GainFirst prenatal care visit to 36 weeks gestationWeight gained during pregnancy
Infant Weight-for-Length Z-scoreChild age 12 monthsAge- and sex-specific weight-for-length z-score

Secondary

MeasureTime frameDescription
Change from 1st trimester maternal sedentary time to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)Hours per day of screentime
Change from 1st trimester depression to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)Edinburgh Postnatal Depression Scale
Change from 1st trimester maternal food insecurity to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)2-question validated scale
Change from 1st trimester maternal diet to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)Average weekly intake
Change from 1st trimester pregnancy-related anxiety to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)5-question validated scale
Change from 1st trimester enrollment in food assistance programs to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)Yes/No response options for program enrollment in WIC and SNAP
Change from 1st trimester maternal housing insecurity to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)2-question validated scale
Change from 1st trimester maternal physical activity to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)Days per week physically active for at least 30 minutes per day
Change from 1st trimester maternal sleep duration to 3rd trimesterAn average of 18 weeks (1st trimester to 3rd trimester)Average hours per day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026