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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: First 1,000 Days Program Site


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First 1,000 Days Program<br> | Behavioral: First 1,000 Days Program Site<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Gestational Weight Gain | Weight gained during pregnancy | First prenatal care visit to 36 weeks gestation | 
| Infant Weight-for-Length Z-Score | Age- and sex-specific weight-for-length z-score | Child age 6 months | 
| Infant Weight-for-Length Z-score | Age- and sex-specific weight-for-length z-score | Child age 12 months | 
| Infant Weight-for-Length Z-Score | Age- and sex-specific weight-for-length z-score | Child age 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Maternal-child, Overweight, Social Determinants of Health