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Completed

NCT Number: NCT03191591

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.

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Key information

Conditions

Overweight and Obesity Behavior Behavior, Animal Body Weight Diet Habit Feeding Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Sleep Social Determinants of Health

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Maternal Gestational Weight Gain

    Time frame: First prenatal care visit to 36 weeks gestation

    Weight gained during pregnancy

  2. Infant Weight-for-Length Z-Score

    Time frame: Child age 6 months

    Age- and sex-specific weight-for-length z-score

  3. Infant Weight-for-Length Z-score

    Time frame: Child age 12 months

    Age- and sex-specific weight-for-length z-score

  4. Infant Weight-for-Length Z-Score

    Time frame: Child age 24 months

    Age- and sex-specific weight-for-length z-score

Secondary outcomes

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

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

    Average weekly intake

  2. Change from 1st trimester maternal physical activity to 3rd trimester

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

    Days per week physically active for at least 30 minutes per day

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

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

    Average hours per day

  4. Change from 1st trimester maternal sedentary time to 3rd trimester

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

    Hours per day of screentime

  5. Change from 1st trimester depression to 3rd trimester

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

    Edinburgh Postnatal Depression Scale

  6. Change from 1st trimester maternal food insecurity to 3rd trimester

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

    2-question validated scale

  7. Change from 1st trimester maternal housing insecurity to 3rd trimester

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

    2-question validated scale

  8. Change from 1st trimester pregnancy-related anxiety to 3rd trimester

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

    5-question validated scale

  9. Change from 1st trimester enrollment in food assistance programs to 3rd trimester

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

    Yes/No response options for program enrollment in WIC and SNAP

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The Boston Foundation

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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