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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 1645
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: First 1,000 Days Program

Behavioral: First 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The Boston Foundation
• Investigators: Principal Investigator: Elsie Taveras, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• Blake-Lamb T, Boudreau AA, Matathia S, Perkins ME, Roche B, Cheng ER, Kotelchuck M, Shtasel D, Taveras EM. Association of the First 1,000 Days Systems-Change Intervention on Maternal Gestational Weight Gain. Obstet Gynecol. 2020 May;135(5):1047-1057. doi: 10.1097/AOG.0000000000003752.
• Neri Mini F, Saltzman JA, Simione M, Luo M, Perkins ME, Roche B, Blake-Lamb T, Kotelchuck M, Arauz-Boudreau A, Davison K, Taveras EM. Expectant Fathers' Social Determinants of Health in Early Pregnancy. Glob Pediatr Health. 2020 Nov 27;7:2333794X20975628. doi: 10.1177/2333794X20975628. eCollection 2020.
• Cheng ER, Luo M, Perkins M, Blake-Lamb T, Kotelchuck M, Arauz Boudreau A, Taveras EM. Household food insecurity is associated with obesogenic health behaviours among a low-income cohort of pregnant women in Boston, MA. Public Health Nutr. 2023 May;26(5):943-951. doi: 10.1017/S1368980022000714. Epub 2022 Mar 24.
• Cruz-Bendezu AM, Lovell GV, Roche B, Perkins M, Blake-Lamb TL, Taveras EM, Simione M. Psychosocial status and prenatal care of unintended pregnancies among low-income women. BMC Pregnancy Childbirth. 2020 Oct 12;20(1):615. doi: 10.1186/s12884-020-03302-2.
• Blake-Lamb T, Boudreau AA, Matathia S, Tiburcio E, Perkins ME, Roche B, Kotelchuck M, Shtasel D, Price SN, Taveras EM. Strengthening integration of clinical and public health systems to prevent maternal-child obesity in the First 1,000Days: A Collective Impact approach. Contemp Clin Trials. 2018 Feb;65:46-52. doi: 10.1016/j.cct.2017.12.001. Epub 2017 Dec 7.
• Simione M, Moreno-Galarraga L, Perkins M, Price SN, Luo M, Kotelchuck M, Blake-Lamb TL, Taveras EM. Effects of the First 1000 Days Program, a systems-change intervention, on obesity risk factors during pregnancy. BMC Pregnancy Childbirth. 2021 Oct 27;21(1):729. doi: 10.1186/s12884-021-04210-9.
• Taveras EM, Perkins ME, Boudreau AA, Blake-Lamb T, Matathia S, Kotelchuck M, Luo M, Price SN, Roche B, Cheng ER. Twelve-Month Outcomes of the First 1000 Days Program on Infant Weight Status. Pediatrics. 2021 Aug;148(2):e2020046706. doi: 10.1542/peds.2020-046706.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2016
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Social Determinants of Health; Maternal-child
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Overweight; Obesity; Motor Activity; Feeding Behavior
• Other Study ID Numbers: 2016P000801; 1K24DK105989 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No