Clinical trial NCT03191591: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Social Determinants of Health
Physical Activity
Sleep
Feeding Behavior
Diet Habit
Keywords: Overweight
Obesity
Maternal-child
Social Determinants of Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Boston Foundation
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-19
Enrollment: 1645
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Maternal Gestational Weight Gain
timeFrame: First prenatal care visit to 36 weeks gestation
measure: Infant Weight-for-Length Z-Score
timeFrame: Child age 6 months
measure: Infant Weight-for-Length Z-score
timeFrame: Child age 12 months
measure: Infant Weight-for-Length Z-Score
timeFrame: Child age 24 months
Secondary outcomes:
measure: Change from 1st trimester maternal diet to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester maternal physical activity to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester maternal sleep duration to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester maternal sedentary time to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester depression to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester maternal food insecurity to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester maternal housing insecurity to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester pregnancy-related anxiety to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
measure: Change from 1st trimester enrollment in food assistance programs to 3rd trimester
timeFrame: An average of 18 weeks (1st trimester to 3rd trimester)
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Elsie Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.