Obesity and OverweightCHIMENCT06724172
CHIME: Comparing Health Interventions for Maternal Equity
A study testing Self-Management and Community-Based in people with Obesity and Overweight and Nutrition, run by Stanford University at 4 sites in United States.
Trial summary
The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight, Nutrition, Chronic Disease
- What is being tested?
- Self-Management and Community-Based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 795 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Jan 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maternal age 18 years or older
- Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term
- Plans to continue receiving antenatal care at the recruitment site/network
- Maternal characteristics include at least one of the following:
- Self identifies as Black/African American
- Self identifies as Hispanic/Latino/a/e/x
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- Insured by Medicaid
- Maternal ability to speak English or Spanish
- Completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization)
Who cannot join
- Age < 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent
- Underweight (BMI <18 kg/m2) at pre-pregnancy period
- Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Unwillingness or inability to complete study visits or intervention components
- Unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site
- Multiple gestations
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
New York Presbyterian Queens
Flushing, New York, 11355
Research Coordinator, 718-670-1707, rjv9007@nyp.org
Daniel Skupski, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10012
Maxine Ashby-Thompson, EdD, MPH, 212-342-2969, ma453@cumc.columbia.edu
Dympna Gallagher, EdD
- Recruiting
NYU Langone Health
New York, New York, 10016
Tanisha Green, (646) 501-3868, tanisha.green@nyulangone.org
Natasha Williams, EdD, MPH
- Active, not recruiting
Stanford University
Palo Alto, California, 94304
About this study
The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum.
The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum.
Read more
Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group.
Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention.
Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of:
- Questionnaires
- Dietary recalls
- In-depth interviews
- Anthropometric measurements
- Collection of blood via finger stick or blood panel
- Conditions
- Obesity and Overweight, Nutrition, Chronic Disease, Diabetes, Pregnancy
- Being tested
- Self-Management, Community-Based
- Medical subject headings
- Obesity, Overweight, Chronic Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-ManagementBehavioural
We will universally offer social needs supports (grocery, physical activity, transportation support) widely in use in clinical settings. Patients may elect to receive all, some, or none of the supports. The patient-directed, structured self-management intervention will be provided through mobile health technology (mHealth) and/or mailings, according to patient preference. Participants will receive health information to support health education and behavior change.
Community-BasedBehavioural
As is currently in use broadly by community health workers, participants will complete a detailed social needs assessment and active assistance with referrals to evidence-based home visiting programs; maternal child health services to promote social support and resource access; and services to improve social determinants of health including active enrollment assistance for WIC, SNAP, healthcare and insurance, legal support, housing, job training, mental health and others. Community health workers will deliver group and individual physical activity support and assistance with behavioral goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Self-Management | Experimental | A self-management intervention through direct provision of social needs supports (grocery, physical activity, and transportation support) with self-directed behavior change tools and usual care. Receives: Behavioral: Self-Management |
| Community-Based | Experimental | A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care. Receives: Behavioral: Community-Based |
| Usual Care | No intervention | Patients randomized to the usual care control group will not receive the study interventions. Instead, these patients will receive usual care which includes social needs screening in the clinical setting, targeted community service and program referrals, clinical decision support tools for social needs support in the electronic health record, and routine clinical care with provider-based lifestyle counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal postpartum weight retention at 12-months postpartum.
The primary outcome will be calculated as the difference between baseline weight and 12-month postpartum weight. Baseline weight will be defined as the first clinical measure of maternal weight prior to 12 weeks gestation.
Measured: From enrollment to the end of the intervention at 12 months postpartum.
Secondary outcomes (1)
Household social needs and maternal perinatal health outcomes
We will obtain patient self-reported measures where applicable for secondary outcomes through validated questionnaires. Secondary outcomes include household food security, gestational weight gain, gestational diabetes, with maternal race and ethnicity and pre-pregnancy body mass index category as effect modifiers.
Measured: From enrollment to the end of the intervention at 12 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start22 Jan 2026
- Primary completion15 Jan 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 795 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jennifer Woo Baidal, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724172
- Sponsor's protocol ID
- 77034
- Other IDs
- 20244792
- Acronym
- CHIME
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHIME: Comparing Health Interventions for Maternal Equity
- ClinicalTrials.gov ID
- NCT06724172
- Acronym / sponsor ID
- CHIME / 77034
- Conditions
- Obesity and Overweight, Nutrition, Chronic Disease, Diabetes, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 795 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum.
The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum.
Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group.
Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention.
Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of:
- Questionnaires
- Dietary recalls
- In-depth interviews
- Anthropometric measurements
- Collection of blood via finger stick or blood panel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Management | Experimental | Behavioral: Self-ManagementA self-management intervention through direct provision of social needs supports (grocery, physical activity, and transportation support) with self-directed behavior change tools and usual care. |
| Community-Based | Experimental | Behavioral: Community-BasedA community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care. |
| Usual Care | No intervention | –Patients randomized to the usual care control group will not receive the study interventions. Instead, these patients will receive usual care which includes social needs screening in the clinical setting, targeted community service and program referrals, clinical decision support tools for social needs support in the electronic health record, and routine clinical care with provider-based lifestyle counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Maternal age 18 years or older
- Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term
- Plans to continue receiving antenatal care at the recruitment site/network
- Maternal characteristics include at least one of the following:
- Self identifies as Black/African American
Key exclusion criteria (6 listed)
- Age < 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent
- Underweight (BMI <18 kg/m2) at pre-pregnancy period
- Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Unwillingness or inability to complete study visits or intervention components
- Unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-ManagementWe will universally offer social needs supports (grocery, physical activity, transportation support) widely in use in clinical settings. Patients may elect to receive all, some, or none of the supports. The patient-directed, structured self-management intervention will be provided through mobile health technology (mHealth) and/or mailings, according to patient preference. Participants will receive health information to support health education and behavior change. | Behavioural | Self-Management |
| Community-BasedAs is currently in use broadly by community health workers, participants will complete a detailed social needs assessment and active assistance with referrals to evidence-based home visiting programs; maternal child health services to promote social support and resource access; and services to improve social determinants of health including active enrollment assistance for WIC, SNAP, healthcare and insurance, legal support, housing, job training, mental health and others. Community health workers will deliver group and individual physical activity support and assistance with behavioral goal setting. | Behavioural | Community-Based |
Primary outcome
Maternal postpartum weight retention at 12-months postpartum.
Time frame: From enrollment to the end of the intervention at 12 months postpartum.
The primary outcome will be calculated as the difference between baseline weight and 12-month postpartum weight. Baseline weight will be defined as the first clinical measure of maternal weight prior to 12 weeks gestation.
1 secondary outcome
Household social needs and maternal perinatal health outcomes
Time frame: From enrollment to the end of the intervention at 12 months postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management and Community-Based in people with Obesity and Overweight and Nutrition, run by Stanford University at 4 sites in United States.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Woo Baidal Associate Professor, MD, MPH (650-721-2250, jwoo1@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal postpartum weight retention at 12-months postpartum. (time frame: From enrollment to the end of the intervention at 12 months postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.