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

Primary Purpose

Overweight and Obesity, Social Determinants of Health, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
First 1,000 Days Program Site
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Overweight, Obesity, Maternal-child, Social Determinants of Health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    First 1,000 Days Program

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maternal Gestational Weight Gain
    Weight gained during pregnancy
    Infant Weight-for-Length Z-Score
    Age- and sex-specific weight-for-length z-score
    Infant Weight-for-Length Z-score
    Age- and sex-specific weight-for-length z-score
    Infant Weight-for-Length Z-Score
    Age- and sex-specific weight-for-length z-score

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 9, 2017
    Last Updated
    September 10, 2021
    Sponsor
    Massachusetts General Hospital
    Collaborators
    The Boston Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03191591
    Brief Title
    The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life
    Official Title
    The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 9, 2016 (Actual)
    Primary Completion Date
    March 18, 2021 (Actual)
    Study Completion Date
    March 18, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    The Boston Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity, Social Determinants of Health, Physical Activity, Sleep, Feeding Behavior, Diet Habit
    Keywords
    Overweight, Obesity, Maternal-child, Social Determinants of Health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    1645 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    First 1,000 Days Program
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    First 1,000 Days Program Site
    Intervention Description
    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 Outcome Measure Information:
    Title
    Maternal Gestational Weight Gain
    Description
    Weight gained during pregnancy
    Time Frame
    First prenatal care visit to 36 weeks gestation
    Title
    Infant Weight-for-Length Z-Score
    Description
    Age- and sex-specific weight-for-length z-score
    Time Frame
    Child age 6 months
    Title
    Infant Weight-for-Length Z-score
    Description
    Age- and sex-specific weight-for-length z-score
    Time Frame
    Child age 12 months
    Title
    Infant Weight-for-Length Z-Score
    Description
    Age- and sex-specific weight-for-length z-score
    Time Frame
    Child age 24 months
    Secondary Outcome Measure Information:
    Title
    Change from 1st trimester maternal diet to 3rd trimester
    Description
    Average weekly intake
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester maternal physical activity to 3rd trimester
    Description
    Days per week physically active for at least 30 minutes per day
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester maternal sleep duration to 3rd trimester
    Description
    Average hours per day
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester maternal sedentary time to 3rd trimester
    Description
    Hours per day of screentime
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester depression to 3rd trimester
    Description
    Edinburgh Postnatal Depression Scale
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester maternal food insecurity to 3rd trimester
    Description
    2-question validated scale
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester maternal housing insecurity to 3rd trimester
    Description
    2-question validated scale
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester pregnancy-related anxiety to 3rd trimester
    Description
    5-question validated scale
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)
    Title
    Change from 1st trimester enrollment in food assistance programs to 3rd trimester
    Description
    Yes/No response options for program enrollment in WIC and SNAP
    Time Frame
    An average of 18 weeks (1st trimester to 3rd trimester)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elsie Taveras, MD, MPH
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32282612
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    34706698
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    34326179
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    33046003
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    29225195
    Citation
    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.
    Results Reference
    derived

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

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