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
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
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
NCT ID
NCT03191591
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)
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
Learn more about this trial
The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life
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