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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03191591
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : September 13, 2021
Sponsor:
Collaborators:
The Boston Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Elsie Taveras, MD, 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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Social Determinants of Health Physical Activity Sleep Feeding Behavior Diet Habit Behavioral: First 1,000 Days Program Site Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1645 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life
Actual Study Start Date : August 9, 2016
Actual Primary Completion Date : March 18, 2021
Actual Study Completion Date : March 18, 2021

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191591


Sponsors and Collaborators
Massachusetts General Hospital
The Boston Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Elsie Taveras, MD, MPH Massachusetts General Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elsie Taveras, MD, Chief, Division of General Academic Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03191591    
Other Study ID Numbers: 2016P000801
1K24DK105989 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elsie Taveras, MD, Massachusetts General Hospital:
Overweight
Obesity
Maternal-child
Social Determinants of Health
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight