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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191591
• Other study ID #: 2016P000801
• Secondary ID: 1K24DK105989
• Status: Completed
• Phase: N/A
• Start date: August 9, 2016
• Est. completion date: March 18, 2021

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1645
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Boston Foundation

References & Publications (1)

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: — View Citation

Outcome

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