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The HOME Study was first established with funding support in 2001 from the National Institute of Environmental Health Sciences (NIEHS), the Environmental Protection Agency (EPA) and the Department of Housing and Urban Development (HUD). In 2007, the NIEHS awarded additional funds to extend the study. Additional grants from the NIH and private foundations have also supported this research. The objective of the study is to examine the effect of low-level exposures (pre- and postnatal) to prevalent toxicants on health, developmental, and behavioral outcomes, to examine meconium levels as measures of in utero exposures to environmental toxicants, and to test the efficacy of lead and injury hazard controls.
Examine the impact of low-level exposures (pre- and postnatal) to prevalent neurotoxins with neurobehavioral outcomes and specific development conditions, including conduct disorder and behaviors consistent with ADHD. Conduct a nested, randomized controlled trial to test the efficacy of lead hazard controls on blood lead concentrations and developmental conditions, and the efficacy of injury hazard controls on injury incidence and severity.
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. We identified women by using the medical scheduling systems of nine prenatal practices affiliated with three hospitals in Cincinnati.
Letters were mailed to 5,512 pregnant women for recruitment. Of these, we surveyed 5,184 (94 percent) women to determine eligibility. Of the 1,263 eligible women, 468 (37 percent) 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.
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 are 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 prevention 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 could be 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 were completed in obstetric offices for the purpose of obtaining informed consent and collecting biological specimens from pregnant women. A home visit was completed prenatally to collect baseline exposure data and assess homes for potential lead and injury hazards. After birth, we completed study visits in the hospital to collect biological specimens, review medical records, and perform an infant assessment. We then conducted home visits at 4 weeks and annually until children reached 3 years of age. During these visits, we collected environmental samples to assess the duration of benefits of lead hazard and injury reduction. Additionally, we gathered survey data that provided information about study participants’ exposure to environmental chemicals, nutritional intake, medical history, respiratory health, development, behaviors, supervision needs and residential injuries. Study clinic visits have also been completed on an annual basis to age 5 years to conduct child developmental assessments, obtain biological specimens, collect child anthropometrics and administer parent surveys.
Phone questionnaires are administered to collect data regarding residential injuries to the index child and siblings, maternal supervision, infant feeding, medical history, developmental milestones and sleep patterns.
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