No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 Day and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
144 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Who this trial is looking for
This trial is looking for infants and their caregivers who are from racial or ethnic minority groups or have low income. Participants will take part in four obesity prevention sessions during regular doctor visits over nine months.
Are You a Good Fit for This Trial?
You may be able to join if
I weigh 2500 grams or more at birth.
I was born between 37 and 42 weeks of pregnancy.
I speak English.
I receive care at the pediatric primary care setting.
I am from a racial or ethnic minority group.
I come from a low-income background qualifying for Medicaid.
You may not be able to join if
I spent more than 7 days in the Neonatal Intensive Care Unit.
My infant has a feeding-related condition or congenital anomaly.
My infant was exposed to illegal drugs before birth, except for THC.
I have diminished or impaired cognitive functioning.
My family plans to move from the area within a year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 deli…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* born 2500 grams or greater
* delivery occurring between 37 and 42 weeks gestation
* English speaking
* infant receiving care provided at our pediatric primary care setting
* from a racial / ethnic minority group (i.e., non-white, or Hispanic or Latinx) and/or economically marg…
Inclusion Criteria:
* born 2500 grams or greater
* delivery occurring between 37 and 42 weeks gestation
* English speaking
* infant receiving care provided at our pediatric primary care setting
* from a racial / ethnic minority group (i.e., non-white, or Hispanic or Latinx) and/or economically marginalized background (i.e., household income at or below 138% of federal poverty level; qualifying for Medicaid)
Exclusion Criteria:
* care in the Neonatal Intensive Care Unit (\>7 days)
* infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)
* infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\]
* diminished or impaired caregiver cognitive functioning
* family intent to move from the area within 1 year
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