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

Not Applicable

Completed

• Conditions: Social Determinants of Health; Diet Habit; Overweight and Obesity; Physical Activity; Sleep; Feeding Behavior
• Interventions: Behavioral: First 1,000 Days Program Site

• Registration Number: NCT03191591
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-09
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Primary Completion: 2021-03-18
• Study Completion: 2021-03-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1645

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
First 1,000 Days Program	First 1,000 Days Program Site	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from 1st trimester maternal diet to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	Average weekly intake
Change from 1st trimester maternal physical activity to 3rd trimester	An 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 trimester	An average of 18 weeks (1st trimester to 3rd trimester)	Average hours per day
Change from 1st trimester maternal sedentary time to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	Hours per day of screentime
Change from 1st trimester depression to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	Edinburgh Postnatal Depression Scale
Change from 1st trimester maternal food insecurity to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	2-question validated scale
Change from 1st trimester maternal housing insecurity to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	2-question validated scale
Change from 1st trimester pregnancy-related anxiety to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	5-question validated scale
Change from 1st trimester enrollment in food assistance programs to 3rd trimester	An average of 18 weeks (1st trimester to 3rd trimester)	Yes/No response options for program enrollment in WIC and SNAP