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What is this study?

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are: * 1\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are: * 1\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized? * 2\) Will it prevent rapid weight gain during infancy? Participants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Babies born weighing at least 2500 grams
•Babies born between 37 and 42 weeks of pregnancy (gestation)
•English-speaking families
•Babies receiving care at the study’s pediatric primary care setting
•Families from a racial/ethnic minority group and/or who are economically marginalized (public insurance/Medicaid; household income at or below 138% of the federal poverty level)

🚫 You may not be able to join if…

•Babies who needed the Neonatal Intensive Care Unit (NICU) for more than 7 days
•Babies with a congenital anomaly or a newborn condition that affects feeding (for example, cleft lip/palate, metabolic disease)
•Babies exposed to illicit drugs in the womb (pregnancy) except tetrahydrocannabinol (THC)
•If the caregiver has diminished or impaired cognitive functioning
•Families who plan to move out of the area within 1 year

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are: * 1\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized?

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

A Novel Obesity Prevention Program for High-Risk Infants in Primary Care