Young Children May Be Exposed to a Variety of Emerging Chemicals Found in Some Consumer Products

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Young Children May Be Exposed to a Variety of Emerging Chemicals Found in Some Consumer Products

Author(s): Jiwon Oh, Deborah H. Bennett, et al.

 

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of the Director, National Institutes of Health supported this research.

 

Why was this study needed?

Over time, exposure to chemicals like triclosan, parabens, phthalates, and PAHs became less common, likely because of new rules and bans on their use. However, replacement chemicals—like DINCH, a chemical that has replaced phthalates in some plastic products—and some pesticides have been showing up more often in later years. Exposure to multiple chemicals during pregnancy and early childhood is a concern because these are critical stages of development when children are more vulnerable to harm. Such exposures can increase their risk of health problems later in life. There is limited data tracking young children’s – 2 to 4 years - exposure to environmental chemicals compared to older children. Prenatal and early-life exposure to these chemicals can increase the risk of multiple adverse child health outcomes. This study aimed to investigate early childhood exposures to a variety of environmental chemicals.

 

What were the study results?

Scientists measured 111 different chemicals in urine samples from young children and their mothers during pregnancy. More than half of the samples contained chemicals such as environmental phenols, pesticides, phthalates, and chemical markers of exposure to polycyclic aromatic hydrocarbons (PAH). About 34 chemicals were found in over 90% of the total samples. Compared to their mothers during pregnancy, children had higher amounts of certain chemicals, like bisphenol S (BPS)—a chemical used in some hard plastics and synthetic fibers as a replacement for BPA—and pesticide-related compounds. On the other hand, mothers had higher levels of chemicals like triclosan and monoethyl phthalate (MEP), markers of exposure to chemicals found in some consumer products like soaps and cosmetics.

Certain groups of children, such as younger kids, later-born siblings, and those from families with fewer resources, were exposed to higher levels of chemicals.

 

What was the study's impact?

This study suggests that young children may be exposed to a variety of emerging and replacement chemicals that may affect their health later in life. Continued monitoring in larger populations of young children can help researchers better understand how these exposures affect children’s long-term health.

 

Who was involved?

The study included 201 children aged 2-4 years and their mothers recruited from six ECHO Cohort study sites across the United States.

 

What happened during the study?

Researchers collected urine samples from each child and their mother during pregnancy. These samples were analyzed for the levels of 111 different chemicals related to environmental exposures. The concentrations of these chemicals were compared between child and prenatal maternal samples. The researchers also examined social and environmental factors that may have influenced the concentration of each chemical in children's urine samples, such as race, ethnicity, maternal education, maternal age, and neighborhood opportunity.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

 

What happens next?

Additional studies tracking early childhood exposures to a variety of contemporary and emerging chemicals could help researchers better understand the potential effects these exposures may have on children’s short and long-term health.

 

Where can I learn more?

Access the full journal article, titled “Exposures to Contemporary and Emerging Chemicals Among Children Aged 2-4 Years in the United States Environmental Influences on Child Health Outcomes (ECHO) Cohort,” in Environmental Science & Technology.

 

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published June 30, 2025

 

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Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

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Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

Author(s): Lori A. Devlin, Zhuopei Hu, Stephanie L. Merhar, et al.

 

Why was this study conducted?

This secondary analysis of infants enrolled in the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) trial, which was conducted at 26 hospitals across the U.S., focused specifically on infants who received opioid treatment for NOWS after birth. The analysis was conducted to identify whether the ESC care approach decreased total postnatal opioid exposure when compared to sites’ usual care practices, which included the use of the Finnegan Neonatal Abstinence Scoring Tool (FNAST).

 

What was done?

The authors analyzed data from 463 infants who were enrolled in the ESC-NOW trial. All infants were born at 36 weeks’ gestation or later and received pharmacologic treatment for NOWS after birth. Three hundred and twenty infants were assessed and managed for NOWS with usual care, and 143 infants were assessed and managed with the ESC care approach.

 

What was found?

In this subgroup analysis, the authors found that total postnatal opioid exposure was substantially less for infants who were assessed and managed with the ESC care approach when compared to usual care.

The absolute mean difference in total opioid exposure was 4.1 morphine milligram equivalents (MME)/kilogram (kg) less for infants in the ESC group when compared to the usual care group (4.8 vs. 8.9 MME/kg respectively). Infants in the ESC group also received an average of 48.7 fewer opioid doses than those in the usual care group (67.5 vs. 116.1 doses respectively). In addition, the mean length of opioid treatment was 6.3 days less in the ESC group than in the usual care group (11.8 vs. 18.1 days respectively), and the mean length of hospital stay was 6.2 days less in the ESC group than in the usual care group.

The authors also found that the mean time from birth to the initiation of pharmacologic care was 22.4 hours longer in the ESC group than in the usual care group (75.4 vs. 53.0 hours respectively), but there was no difference in the mean peak opioid dose between groups.

 

What do the results mean?

  1. Infants who were assessed and managed with the ESC care approach received less opioid medication for the treatment of NOWS after birth when compared to those who were assessed and managed with usual care, including the FNAST.
  2. Infants assessed and managed with the ESC care approach also had fewer days of opioid treatment and a shorter length of hospital stay when compared to usual care.
  3. The time from birth to the initiation of opioid treatment was longer in infants who were assessed and managed with the ESC care approach, but there was no difference in the peak dose of opioid medication, which suggests that the ESC care approach aptly assesses and supports acute opioid withdrawal.

 

Who sponsored this study?

This clinical trial is a collaboration between the NIH Environmental influences on Child Health Outcomes (ECHO) Program and the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), funded through the NIH Helping to End Addiction Long-term® Initiative (HEAL).

 

Where can I learn more?

Access the full journal article, titled “Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid WithdrawalA Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial,” in JAMA Pediatrics.

 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

 

Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

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Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

Study title: Validation of remote height and weight assessment in a rural randomized pediatric clinical trial in primary care settings

Author(s): E (Alice) Zhang, Ann M. Davis, Elizabeth Yakes Jimenez, Brittany Lancaster, Monica Serrano-Gonzalez, Di Chang, Jeannette Lee, Jin-Shei Lai, Lee Pyles, Timothy VanWagoner, Paul Darden

 

Why was this study conducted?

Children living in rural areas have a greater risk for overweight. It may also be hard for them to join weight management programs or studies that require in-person visits. This study compared the accuracy of at-home height and weight measurements to those taken in person at a clinic.

 

What was done?

A total of 33 parent/child pairs took part in the study; the children were 6-11 years old. We gave each pair a digital bathroom scale, a tape measure, and instructions on measuring height and weight. Then, we guided them as they took their in-home measurements through a video call. The pairs also came to the clinic for their in-person measurements. Then, we compared the at-home and in-person measurements.

 

What was found?

There were no significant differences in the overall height and weight measurements taken at home compared to those taken in person at the clinic. However, some individual heights and weights differed significantly between at-home and in-person measurements. Age, race, ethnicity, parent education level, household income, and zip code were not significant predictors of at-home and in-person measurement comparisons.

 

What do the results mean?

It is possible to use everyday tools and technology to measure the weight and height of children living in rural areas. However, using these tools might reduce the accuracy of the measurements. Researchers and clinicians need to decide how accurate they need measurements to be before using these tools in the home.

 

Who sponsored the study?

This research was supported by the Environmental Influences on Child Health Outcomes (ECHO) program, the office of the Director, National Institutes of Health.

 

Appreciation

The researchers thank the wonderful families who made this work possible. We also thank Drs. Rebecca Romine and Kandace Fleming from the Life Span Institute, University of Kansas, for their input on data interpretation.

 

You may learn more about this publication here: https://www.nature.com/articles/s41598-023-50790-1

 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

 

Published: January 3, 2024

A Qualitative Exploration of COVID-19 Vaccine Hesitancy Among Parents

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A Qualitative Exploration of COVID-19 Vaccine Hesitancy Among Parents

Authors: Aubree Honcoop, James R Roberts, Boyd Davis, Charlene Pope, Erin Dawley, Russell McCulloh, Maryam Y Garza, Melody L Greer, Jessica Snowden, Linda Y Fu, Heather Young, Walter Dehority, Paul Enlow, Delma-Jean Watts, Katie Queen, Lisa Costello, Zain Alamarat, Paul M Darden

 

Why was this study conducted?

Research has shown that the COVID-19 vaccine is safe and effective at protecting children from severe COVID-19 disease. However, some parents have not yet vaccinated their children. Fewer children from a rural, Spanish-speaking, or Black backgrounds have received the vaccine than others.[i] We wanted to find out what parents from these groups think about the vaccine for their children. We interviewed parents about their concerns to learn how to address them and build their confidence in the vaccines.

 

What was done?

We selected 36 parents who lived in rural areas, spoke Spanish, and/or identified as Black. We only included parents with one or more unvaccinated children. We spoke with them about their thoughts for or against the COVID-19 vaccine.

 

What was found?

Many parents, whether they were for, against, or unsure about the COVID-19 vaccine, reported that they would listen to their doctor for vaccine information. Some parents wanted to know how well the vaccine protects children. Some parents also considered their child’s preferences for getting the vaccine. Others were concerned about the vaccine causing side effects or impacting health conditions such as asthma.

 

What do the results mean?

These results suggest what topics scientists might include in a mobile app designed to inform parents about the COVID-19 vaccine. However, this information was from a small number of parents and may not apply to people from other backgrounds.

 

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program in the Office of the Director, National Institutes of Health (NIH).

 

Appreciation:

Most of all, we thank the parents who took part in the study. We also thank the site coordinators, clinic staff, and ECHO ISPCTN Data Coordinating & Operations Center staff for their support.

You may learn more about this publication here: https://pubmed.ncbi.nlm.nih.gov/37867449/

To learn more about the COVID-19 vaccine for children, visit:

 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

______________________________________

[i] The National Institutes of Health (NIH) has identified individuals from rural, medically underserved, and migrant communities as high priorities for vaccination and vaccine communication efforts. This includes children living in rural areas, from Spanish-speaking households, or who identify as Black. For current data on COVID-19, including vaccination rates, please visit the CDC website.

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Authors: James Roberts, Sheva Chervinskiy, Russell McCulloh, et al.

Did COVID-19 pandemic experiences contribute to symptoms of traumatic stress in mothers in the U.S.?

Authors: Tracy Bastain, Amy Margolis, et al.

Changes in children sleep habits during the COVID-19 pandemic

Authors: Maristella Lucchini, et al.

 

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Youth Well-being During COVID-19

Author(s): Courtney K. Blackwell, et al.

ECHO Program Collects Valuable Data on Nutrition During Pregnancy and Early Life

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ECHO Program Collects Valuable Data on Nutrition During Pregnancy and Early Life

Authors: Megan Bragg, Kristen Lyall, et al.

 

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of the Director, National Institutes of Health supported this research.

 

Why was the study needed?

Improving nutrition during pregnancy and childhood is a key focus for public health in the United States. Many pregnant women and children face deficiencies in essential vitamins and minerals coupled with excess salt, saturated fats, and sugars in their diets. Socioeconomic factors may affect access to nutritious food, contributing to disparities in rates of diet-related chronic disease that could affect pregnancy outcomes and child growth and development. Often, data collected on diet provide only a snapshot that can't address how early-life diet affects later child health outcomes. The ECHO Cohort Consortium is addressing these challenges by gathering information over time about the dietary habits of individuals during pregnancy and childhood from a large, diverse group of participants. This study examines the types of diet information collected from the ECHO Cohort and provides examples of how researchers can use this data to learn more about the role of nutrition in child health outcomes.

 

What were the study results?

This study aimed to describe dietary intake data available in the ECHO Program as of August 2022, from pregnancy through adolescence, including estimated sample sizes, and to highlight the potential for future analyses of nutrition and child health. As of that date, 66 ECHO Cohort Study Sites across the country had collected diet information using a variety of methods, including dietary recalls, food frequency questionnaires, and questionnaires about supplement use. Diet information from these study sites is especially useful because it has been collected from a large group of diverse people, and because many families provided information more than once over the course of pregnancy and childhood.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should always consult with a qualified healthcare provider for diagnosis and for answers to your personal questions.

 

What was the study's impact?

This study highlights the large amount of diet information already available from the ECHO Cohort and the opportunities for researchers to access this publicly available resource to answer important questions about nutrition and child health outcomes.

 

Who was involved?

This study examined data from pregnant women and children at 66 ECHO Cohort Study Sites in 34 U.S. states who answered questions about their diets by August 2022. Data about more than 26,000 pregnant women and 27,000 children is publicly available.

 

What happened during the study?

Researchers examined the diet information that study sites collected from pregnant women and children through August 2022, including questionnaires and medical records. Researchers sorted this information by the type of questionnaire and whether it was from a pregnant woman or a child. Many participants contributed data from both the pregnant woman and the child and reported on their diet more than once.

 

What happens next?

The ECHO Program will continue to collect diet information from participants. Information from over 33,000 pregnancies and more than 31,000 children in the ECHO Program is now accessible to researchers. This de-identified data is publicly available to researchers through the National Institute of Child Health and Human Development Data and Specimen Hub (DASH) to encourage broad use to answer important questions about nutrition and child health.

 

Where can I learn more?

Access the full journal article, titled “Opportunities for examining child health impacts of early-life nutrition in the ECHO Program: Maternal and child dietary intake data from pregnancy to adolescence” in Current Developments in Nutrition.

 

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published November 2023

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New ECHO Research Reveals Communication, Collaboration, and Team Science Are Central to the Success of Large, Multi-Site Research Programs

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New ECHO Research Reveals Communication, Collaboration, and Team Science Are Central to the Success of Large, Multi-Site Research Programs

Authors: Elissa Faro, et al.

 

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of The Director, National Institutes of Health supported this research.

 

Why was the study needed?

Large research collaboratives often have more success than single investigators conducting research alone. They produce more publications in journals with higher impact factors that result in more citations and continued research opportunities. As a result, funding agencies continue to increase their support for large, transdisciplinary research groups to address complex and challenging health problems.

The National Institutes of Health’s (NIH) Environmental influences on Child Health Outcomes (ECHO) Program developed multi-site collaboration strategies to promote high-impact, collaborative, observational research on child health. However, few studies have investigated the perspectives of researchers and staff of large research projects like ECHO. Many questions remain about team science, including the effects of research structures and funding mechanisms on team functioning. To address these questions, ECHO researchers sought to develop an in-depth understanding of the elements and conditions that influence the implementation of observational research in the ECHO Program.

 

What were the study results?

Researchers interviewed 24 ECHO investigators and staff and found that communication and working as a team were important for successful collaborations. Most interviewees expressed a desire for more opportunities for direct connection, learning, and sharing with their colleagues. While respondents mostly spoke positively about ECHO’s investigative network and opportunities to collaborate, researchers learned that some respondents felt the network could benefit from engaging more team members across various roles in decision-making processes.

Some interviewees also expressed that communication and the decision-making process within the program may need improvement, but they shared that they had observed the ECHO Program   improving in this regard. They also recognized that the size of the program might contribute to delays with timely, clear, and efficient communication. Overall, respondents felt the ECHO Program excels at conducting solution-oriented, high-impact child health research, but also that the Program has an opportunity to further improve communication, collaboration and decision-making across its vast network of sites and components.

 

What was the study's impact?

This study contributes insight on the implementation of a large, multidisciplinary research consortium, and these lessons may be transferable to other large research consortia. The findings also offer an in-depth understanding of why and how research stakeholders collaborate, and what strategies work better to produce high-impact science.

The study found that ECHO researchers highly valued team science, co-learning, and collaboration. The range of experiences across the program suggests that best practices for large research ventures like ECHO may not be one-size-fits-all but may instead need to be tailored for different groups. However, the collected responses may inform new methods to enhance communication and collaboration across large research consortia in the future.

This study will benefit a variety of research stakeholders, including government agencies and other funding organizations, when they support and design large research projects.

 

Who was involved?

Researchers conducted 24 interviews with ECHO researchers and staff. Most interviewees were affiliated with a study site, but the research team was also able to gather the perspectives of all ECHO Program components except for the Human Health Exposure Analysis Resource (HHEAR)—the ECHO component responsible for testing samples from ECHO participants to help researchers assess the effects of chemical exposures—and the NIH.

 

What happened during the study?

In early 2022, researchers conducted 24 virtual interviews. The research team interviewed internal stakeholders from the ECHO study sites and components, seeking broad representation of research and administrative roles across ECHO. All internal stakeholders were informed of the study via email, and those interested were able to contact the research team and schedule an interview via Zoom. From the respondents, researchers selected a sample to maximize variation and represent diverse perspectives from across ECHO.

The research team developed a semi-structured interview guide, and analyzed both the quantitative and qualitative data collected to understand how individual researcher’s experiences and perspectives reflect the overall implementation of the ECHO Program. As part of this analysis, the researchers tracked metrics organized around four central goals: (1) enrolling and retaining a large and diverse group of participants in ECHO to answer key scientific questions; (2) collecting high-quality data and making it available for analysis; (3) collecting, storing, and using biospecimen samples and data; and (4) publishing and disseminating high-quality, impactful science. These metrics provide complementary, quantitative assessment of ECHO implementation and progress toward key goals and priorities.

 

What happens next?

Future studies are needed to understand how collaborative research affects the experiences of ECHO study participants as well as the perspectives of external stakeholder groups.

 

Where can I learn more?

Access the full journal article, titled “A Mixed-Methods Analysis to Understand the Implementation of a Multi-stakeholder Research Consortium: Environmental influences on Child Health Outcomes (ECHO),” in the Journal of Clinical and Translational Science.

 

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published October 12, 2023

 

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ECHO Cohort Study Identifies Best Tests of Biological Age to Use for Different Types of Pediatric Tissue Samples

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ECHO Cohort Study Identifies Best Tests of Biological Age to Use for Different Types of Pediatric Tissue Samples

Authors: Fang Fang, et al.

 

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of The Director, National Institutes of Health supported this research.

 

Why was the study needed?

A molecular process called DNA methylation, or DNAm, that adds a tag to the DNA that can control gene expression. Certain well-studied DNAm have been associated with many age-related chronic diseases, including aging itself.

Researchers have developed biochemical models called epigenetic clocks that use DNAm to estimate an individual’s biological age. Scientists have studied these clocks in adult populations in whom accelerated biological age (DNAm-predicted age older than actual chronological age) seems strongly connected to age-related health complications. However, only epigenetic clocks for pediatric populations have only recently been built. Epigenetic clocks also allow scientists to evaluate the impact of various environmental exposures on early-life development and children’s health outcomes.

This study conducted a comprehensive evaluation on seven of these epigenetic clocks—Horvath, Knight, Bohlin, Lee, Mayne, PedBE, and NeoAge—all of which researchers developed for different purposes and tissue types. It is important for scientists to understand how these clocks perform in different tissue types and developmental stages throughout early life to ensure researchers are designing studies appropriately and then correctly interpreting the results of these studies.

 

What were the study results?

The results of this study suggest that the best epigenetic clock to use depends on the type of sample being studied. For example, the Bohlin and Knight clocks were very similar when predicting gestational age from blood cell samples; the Lee clock outperformed the Mayne clock in predicting gestational age from placental samples; and the PedBE clock was more accurate than the Horvath clock at predicting chronological age from buccal cells. However, the Horvath clock was better at predicting chronological age when using blood cells samples.  The study results suggest the importance of researchers choosing the appropriate clock depending on the focus of their study.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

 

What was the study's impact?

This study provides practical recommendations for selecting the most appropriate epigenetic clock in different research contexts, therefore leading to more accurate estimates of biological age. The findings of this study may help scientists make better research tools, improving child health research.

 

Who was involved?

Researchers used data from 3,789 children, who contributed a total of 4,555 samples, from 20 ECHO research sites. The sample set consisted of 2,273 male and 2,282 female samples.

 

What happened during the study?

The researchers evaluated seven different epigenetic clocks based on the DNAm data generated from the selected sample set. The study evaluated each clock in corresponding tissues based on previous study results, and then compared clocks across different tissue samples. After comparing the suitability of various epigenetic clocks for each tissue type, researchers evaluated their performance across diverse populations. This evaluation included comparing epigenetic clocks between preterm and term infants within the same tissue type, across different self-reported racial groups, between males and females, and across different tissue types within the same set of participants.

 

What happens next?

Future studies may use the various epigenetic clocks as recommended to check the health of babies and children. However, researchers should interpret this data with caution as it pertains to conclusions about the performance of specific epigenetic clocks in pediatric populations with varied health backgrounds. Future studies may examine the effects of genetics on the performance of different epigenetic clocks.

 

Where can I learn more?

Access the full journal article, titled “Evaluation of Pediatric Epigenetic Clocks Across Multiple Tissues,” in Clinical Epigenetics.

 

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published October 9, 2023

 

Access the associated article.

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Authors: Claudia Buss, Nora K. Moog

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Effects of Metal Mixture Exposure During Pregnancy on Fetal Growth

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Rural Family Satisfaction with Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics

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Rural Family Satisfaction with Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics

Author(s): Nguyen L, Phan TL, Falini L, Chang D, Cottrell L, Dawley E, Hockett CW, VanWagoner T, Darden PM, Davis AM

 

Why was this study conducted?

Childhood obesity is a serious health problem in the United States and affects more children from rural areas. Experts recommend treating children with obesity within family-based behavioral groups. However, rural areas often don’t have access to these programs. Telehealth is a way to deliver these programs to rural families, but few studies have looked at family satisfaction with behavioral programs delivered this way or who might benefit most from these visits. This study looked at how parents of children living in rural communities rated their experience with telehealth visits to help their child make healthy lifestyle changes, as well as family characteristics associated with satisfaction.

 

What was done?

A study was conducted with families of children aged 6 to 11 years with overweight or obesity living in rural areas. Half of the children received the telehealth program and a health newsletter, while the other half received only the health newsletter. After the study, parents of children who received the telehealth visits rated the visits in four areas:

  • The telehealth technology experience
  • The comfort and privacy they felt with telehealth
  • The speed and ease of getting care with telehealth
  • Their overall satisfaction with telehealth

 

What was found?

Parents were overall very satisfied with the telehealth visits noting they felt comfortable with the technology and satisfied with the privacy. Parents with lower education and income levels reported the highest levels of satisfaction. Race, ethnic group, and in-home internet access did not affect satisfaction ratings.

 

What do the results mean?

These results show that families from rural areas like telehealth visits and that telehealth might be a good way to increase access to treatment for children with overweight or obesity, especially among disadvantaged communities. There are still barriers to overcome, such as health literacy and access to broadband internet and devices. Larger studies are needed to better understand who might benefit most from telehealth.

 

Who sponsored the study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

 

Appreciation:

We sincerely appreciate the clinics, staff, children, and parents who participated in this study. The authors thank the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, National Institutes of Health, for supporting this research.

 

You may learn more about this publication here: https://www.liebertpub.com/doi/10.1089/chi.2022.0210

 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

 

Published: April 10, 2023

Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Authors: James Roberts, Sheva Chervinskiy, Russell McCulloh, Jessica Snowden, Paul Darden, Thao-Ly Phan, Erin Dawley, Victoria Reynolds, Crystal Lim, Lee Pyles, DeAnn Hubberd, Jaime Baldner, Lora Lawrence, Ann Davis

 

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, National Institutes of Health.

 

What was done?

The study's goal was to enroll 128 children aged 6 to 12 years old and one parent at four rural clinics over 10 weeks. However, the trial was paused after 6 weeks due to COVID-19. Over the next 12 weeks, the trial resumed using virtual visits where investigators completed enrollment, obtained informed consent, and assessed height and weight of children. Because all study activity was virtual, digital scales and height measurement equipment were shipped to participants' homes, and a second virtual visit was conducted to monitor these measurements. Some participants who did not have internet and needed support for virtual visits received internet-enabled tablets.

 

What was found?

When the trial was paused, 42 patients had been enrolled. When the trial resumed virtually, 28 of the 42 continued in the trial, and an additional 89 new participants were enrolled for a total of 117 children. Flexibility was key to solving problems and continuing to enroll and retain participants.

The investigators discovered the challenges and benefits of conducting a virtual trial of this nature. Some challenges to conducting a virtual trial include unreliable equipment delivery, unreturned study equipment, slow Internet speeds and/or poor Internet access in rural areas, and the added costs of buying and shipping equipment and mailing other study materials. However, the benefits of a virtual trial included the ability to conduct study visits at other times of the day, including evenings and weekends. For example, research staff could conduct study visits at any time of the day, and study-related travel was limited.

 

What do the results mean?

The lessons learned from this trial can be applied by any study team recruiting participants from rural areas for a clinical trial. These include:

  • Virtual visits and procedures enable successful recruitment and retention of participants from rural areas.
  • Research teams must be agile, flexible, and willing to adapt study procedures to meet clinic resources and unanticipated situations.
  • While there are considerable additional expenses for buying and shipping study equipment to participants, these costs may be offset by decreased travel to and from rural areas by study staff.

 

Why was this study conducted?

In the United States, children living in rural areas have higher rates of being overweight. Unfortunately, children from rural areas seldom participate in clinical research trials. A clinical research trial on changing lifestyle behaviors in rural children who were overweight started in early 2020 but, due to the COVID-19 pandemic, had to switch to virtual procedures instead of in-person visits. Sharing the solutions to problems faced and the lessons learned in completing this trial may help other research teams recruit participants living in rural areas.

 

Appreciation:

The authors appreciate the children, families, and clinics whose participation made the research possible.

 

You can read the full publication here: https://doi.org/10.1017/cts.2022.453

 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

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Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

Author(s): Sara E. Watson, Paul Smith, Jessica Snowden, Vida Vaughn, Lesley Cottrell, Christi A. Madden, Alberta S. Kong, Russell McCulloh, Crystal Stack Lim, Megan Bledsoe, Karen Kowal, Mary McNally, Lisa Knight, Kelly Cowan, Elizabeth Yakes Jimenez

 

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

 

What was done?

The authors conducted a review of published research papers to determine what factors make it easier or harder for children to participate in clinical research studies in rural and community-based settings. The authors considered studies to have been conducted in a “community-based setting” if all activities occurred outside of a clinic or hospital. The team reviewed other published articles to determine what strategies other researchers had used to enroll children in studies and help them stay enrolled until the studies were completed. They then looked to see which strategies were most helpful.

 

What was found?

In this systematic review, there were few published studies that specifically describe useful strategies for enrolling children in rural settings into clinical trials or strategies to help them stay enrolled. Strategies that have been helpful include sending families visit reminders, building relationships with community members, making it easier for families to get to study visits, and paying families for the time they spend participating in the study. Not having enough staff and resources were listed as barriers to enrolling children and helping them stay enrolled in studies.

 

What do the results mean?

More studies are needed to understand the best ways to engage children and their families in rural areas in clinical trials. While many of the factors identified in this review that are barriers to or supporting of research are common across all research—such as participant reminders, building relationships with families, and adequate resources—it is critical that study teams look specifically at issues important to rural communities—such as paying for travel costs and facilitating delivery of study materials to remote sites.

 

Why was this study conducted?

Good clinical trials can help improve patient health outcomes by informing evidence-based medicine and public health interventions. However, children and adults who live in rural settings are underrepresented in clinical trials. This can affect the quality of health care for rural populations and contribute to rural health disparities.

 

You may learn more about this publication here: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13220

 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.