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

NCT03191591 | Completed

• 2 other identifiers: 2016P0008011K24DK105989
• Study Type: interventional
• Target: 1,645
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change from 1st trimester maternal diet to 3rd trimester

  An average of 18 weeks (1st trimester to 3rd trimester)

• Change from 1st trimester maternal physical activity to 3rd trimester

  An average of 18 weeks (1st trimester to 3rd trimester)

• Change from 1st trimester maternal sleep duration to 3rd trimester

  An average of 18 weeks (1st trimester to 3rd trimester)

• Change from 1st trimester maternal sedentary time to 3rd trimester

  An average of 18 weeks (1st trimester to 3rd trimester)

• Change from 1st trimester depression to 3rd trimester

  An average of 18 weeks (1st trimester to 3rd trimester)

Study Arms (1)

First 1,000 Days Program

EXPERIMENTAL

Behavioral: First 1,000 Days Program Site

Interventions

First 1,000 Days Program Site BEHAVIORAL

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.

First 1,000 Days Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Boston Foundation: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (7)

• 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.

  PMID: 33294495 BACKGROUND

• 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.

  PMID: 35321774 BACKGROUND

• 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.

  PMID: 33046003 BACKGROUND

• 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.

  PMID: 29225195 BACKGROUND

• 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.

  PMID: 34706698 BACKGROUND

• 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.

  PMID: 32282612 RESULT

• 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.

  PMID: 34326179 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Study Officials

• Elsie Taveras, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Academic Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 19, 2017
• Study Start: August 9, 2016
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share