Yolton Lab
HOME Study Summary

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HOME Study Summary

The HOME Study was first established with Children’s Environmental Health Center funding support received in 2001 from the National Institute of Environmental Health Sciences (NIEHS) and the Environmental Protection Agency (EPA), as well as funding from the Department of Housing and Urban Development (HUD). Additional funding from federal and foundation sources has continued to support the study.

The study’s objective is to examine the effect of low-level exposures (pre- and postnatal) to prevalent neurotoxicants on health, growth and neurobehavioral outcomes, and to test the efficacy of lead and injury hazard controls completed in the home.

The Start of the HOME Study

Study Aims

Examine the impact of low-level exposures (pre- and postnatal) to prevalent neurotoxicants on health, growth, and neurobehavioral outcomes including broad development, language, cognition and achievement, executive functioning, spatial reasoning, behavior and mood.

Conduct a nested, randomized controlled trial to test the efficacy of lead hazard controls on blood lead concentrations and neurodevelopment, and the efficacy of injury hazard controls on injury incidence and severity.

Recruitment & Enrollment

The recruitment of pregnant women began in March 2003 and was completed in January 2006. The recruitment strategy was developed with the active participation of a local Community Advisory Board and a National Oversight Panel who reviewed the study and provided guidance in addressing research ethics, study design and reporting results to participants. We identified women by using the medical scheduling systems of 9 obstetric practices affiliated with three hospitals in Cincinnati.

5,512 letters were mailed to pregnant women for recruitment. Of these, we surveyed 5,184 (94%) women to determine eligibility. Of the 1,263 eligible women, 468 (37%) initially agreed to participate. At the recommendation of our Community Advisory Board, we instituted a “run-in” period prior to randomization. Once a woman agreed to participate and signed the informed consent form, we delayed a baseline home visit to give her time to thoroughly discuss the study with her family or friends.

Please note: The HOME study is not currently recruiting new participants but continues to follow those who were previously enrolled.

Lead & Injury Hazard Control

The purpose of the randomized trial was to test the efficacy of interventions to prevent lead toxicity and residential injuries in children. All participants were enrolled during pregnancy with the intention of following children until 3 years of age to measure outcomes. In April 2007, the NIEHS awarded additional funds to extend the study to follow children until they were 5 years of age. The extension of this trial was essential to test the efficacy of the intervention on measures of cognitive abilities and behavioral problems that are not stable until 5 years of age.

It was also essential to test the efficacy of the injury intervention during the first 5 years of life, when children are particularly vulnerable to residential injury. Enrolled families were randomly assigned to either the lead hazard reduction arm or the injury reduction arm of the study. There were 174 families assigned to the lead hazard treatment group and 181 assigned to the injury treatment group. The remaining 53 participants fell into a “no intervention” control arm because property owners did not consent to the lead/injury hazard reduction repairs or the participant gave birth before completion of the baseline visit and randomization.

We conducted the lead hazard controls prior to birth, before the children were exposed to lead in their home environment. The injury intervention was implemented when the index child was between 3 and 6 months of age. If a child in the lead treatment group relocated during the first 24 months of life, we conducted lead hazard controls in the new residence if hazards were present. If a child in the injury treatment group relocated during the first 30 months of life, we conducted injury hazard controls in the new residence if hazards were present.

Study Visits

Phase 1

Pregnant women were enrolled in the HOME Study during a doctor’s appointment when they were about 16 weeks pregnant. During pregnancy and through the first three years of life, we collected samples of blood, saliva, breastmilk, hair, and meconium to measure exposure to chemicals such as pesticides, lead, and mercury. Study participants completed home visits and clinic visits when their child was aged 1, 2, and 3 years. These visits consisted of questionnaires and assessments for both caregivers and children.

We also examined ways to make homes safer for children. Participants were randomized (like a flip of a coin) into either a lead reduction group or an injury reduction group. We completed home visits to treat the home to reduce lead exposure or to install injury hazard equipment. Click here to read more about what we found on our publications page.

Phase 2

Phase 2 included clinic visits for children ages 4 and 5 years old. We completed many of the same samples, questionnaires and assessments as in phase 1. In Phase 2, we also asked questions about new chemicals such as bisphenol A (BPA), which is a chemical commonly found in some plastics and canned foods, and phthalates, which are found in some plastics and personal care products.

Phase 3

Phase 3 included clinic visits for children aged 7.5 to 10 years old. In this phase, we focused on the impact of environmental chemicals on child cognition, learning, memory, motor skills, attention, executive function, and behavior. We also examined how environmental chemicals impacted maternal, infant, and child thyroid function.

Phase 4

Phase 4 started in June 2016 and concluded in April 2019, with an impressive number of 256 completed visits. This phase included a clinic visit for children ages 11 to 13 years. We focused on how environmental chemicals impact children’s growth, adiposity (how fat is distributed in the body), endocrine function (hormones), brain anatomy and function, behavior, and mood.

Cincinnati Combined Childhood Cohorts (C4)

In November 2021, the HOME Study joined forces with the Cincinnati Childhood Allergy and Air Pollution Study to examine the role of air pollution in the emergence and persistence of mental health disorders during adolescence and young adulthood. This phase of the study includes surveys completed online and during a clinic visit to assess mental health and collection of biological samples. Eligible participants will also be invited to participate in an MRI study allowing us to see changes in brain structure and function that may accompany mental health outcomes in relation to air pollution exposure. Both studies completed similar work at age 12, allowing us to examine changes over time in both mental health and brain outcomes. Combining the two cohorts will increase the size of our study to 500 participants.

Bone Health

In June 2022, the HOME Study began a new study visit to examine the role of endocrine disrupting chemicals on bone health and density measures. This visit includes surveys in the clinic setting and online, as well as collection of biological samples. Eligible participants are also invited to participate in a dual-energy X-ray absorptiometry (DXA) scan and a peripheral quantitative computed tomography (pQCT), in order for us to measure bone mineral density (BMD) and rate of BMD accrual from 12 to 17 years.

Our Response to the IV Fluid Shortage

Yolton LabHOME Study Summary