AzTrials
AzTrials

Overweight and ObesityNCT03191591

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

A study testing First 1,000 Days Program Site in people with Overweight and Obesity and Social Determinants of Health, run by Massachusetts General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
What is being tested?
First 1,000 Days Program Site
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,645 participants
Where
No sites listed yet
Study dates
9 Aug 2016to 18 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

About this study

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.

Being tested
First 1,000 Days Program Site
Keywords
Overweight, Obesity, Maternal-child, Social Determinants of Health
Medical subject headings
Overweight, Obesity, Motor Activity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • First 1,000 Days Program SiteBehavioural

    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.

Study groups in NCT03191591
Study groupRoleWhat they receive
First 1,000 Days ProgramExperimentalNot described
Receives: Behavioral: First 1,000 Days Program Site

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Gestational Weight Gain

    Weight gained during pregnancy

    Measured: First prenatal care visit to 36 weeks gestation

  2. Infant Weight-for-Length Z-Score

    Age- and sex-specific weight-for-length z-score

    Measured: Child age 6 months

  3. Infant Weight-for-Length Z-score

    Age- and sex-specific weight-for-length z-score

    Measured: Child age 12 months

  4. Infant Weight-for-Length Z-Score

    Age- and sex-specific weight-for-length z-score

    Measured: Child age 24 months

Secondary outcomes (9)

  1. Change from 1st trimester maternal diet to 3rd trimester

    Average weekly intake

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  2. Change from 1st trimester maternal physical activity to 3rd trimester

    Days per week physically active for at least 30 minutes per day

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  3. Change from 1st trimester maternal sleep duration to 3rd trimester

    Average hours per day

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  4. Change from 1st trimester maternal sedentary time to 3rd trimester

    Hours per day of screentime

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  5. Change from 1st trimester depression to 3rd trimester

    Edinburgh Postnatal Depression Scale

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  6. Change from 1st trimester maternal food insecurity to 3rd trimester

    2-question validated scale

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  7. Change from 1st trimester maternal housing insecurity to 3rd trimester

    2-question validated scale

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  8. Change from 1st trimester pregnancy-related anxiety to 3rd trimester

    5-question validated scale

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

  9. Change from 1st trimester enrollment in food assistance programs to 3rd trimester

    Yes/No response options for program enrollment in WIC and SNAP

    Measured: An average of 18 weeks (1st trimester to 3rd trimester)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start9 Aug 2016
  3. Primary completion18 Mar 2021
  4. Study completion18 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
1,645 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191591
Sponsor's protocol ID
2016P000801
Other IDs
1K24DK105989
Status last verified
Dec 2025
First submitted
9 Jun 2017
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Neri Mini F, Saltzman JA, Simione M, Luo M, Perkins ME, Roche B, Blake-Lamb T, Kotelchuck M, Arauz-Boudreau A, Davison K, Taveras EM. Expectant Fathers' Social Determinants of Health in Early Pregnancy. Glob Pediatr Health. 2020 Nov 27;7:2333794X20975628. doi: 10.1177/2333794X20975628. eCollection 2020.

    PubMed 33294495

  • Cheng ER, Luo M, Perkins M, Blake-Lamb T, Kotelchuck M, Arauz Boudreau A, Taveras EM. Household food insecurity is associated with obesogenic health behaviours among a low-income cohort of pregnant women in Boston, MA. Public Health Nutr. 2023 May;26(5):943-951. doi: 10.1017/S1368980022000714. Epub 2022 Mar 24.

    PubMed 35321774

  • 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.

    PubMed 33046003

  • 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.

    PubMed 29225195

  • 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.

    PubMed 34706698

  • 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.

    PubMed 32282612

  • 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.

    PubMed 34326179

Questions about this trial

What is this clinical trial studying?

A study testing First 1,000 Days Program Site in people with Overweight and Obesity and Social Determinants of Health, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Gestational Weight Gain (time frame: First prenatal care visit to 36 weeks gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191591, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in