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 Study Design and Protocols

The National Children’s Study will examine the effects of the environment, as broadly defined to include factors such as air, water, diet, sound, family dynamics, community and cultural influences, and genetics on the growth, development, and health of children across the United States, following them from before birth until age 21 years. The goal of the Study is to improve the health and well-being of children and contribute to understanding the role various factors have on health and disease. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible.

The National Children’s Study plans to follow children from Study locations across the United States. 

The Study is being conducted as an integrated system of activities with multiple interacting components. As the Study evolves, this type of system will allow for overall flexibility in planning, operations, and data analysis including resource allocation, activity coordination, and protocol development. 

There are two related phases of the National Children’s Study: the Vanguard Study and the Main Study. The Vanguard Study began prior to the Main Study and both studies will run in parallel and will follow children from birth to age 21.

The Main Study will focus on exposure outcome relationships with a data driven, evidence-based approach. The Vanguard Study is a pilot study that will be conducted in 40 Study locations and is designed to help provide the detailed preparation needed to implement a study with the broad scope and complexity of the National Children’s Study. The Vanguard Study will evaluate the feasibility, acceptability, and cost of three different recruitment strategies, as well as Study procedures and outcome assessments that are to be used in the Main Study. Feasibility refers to technical performance and reliability; acceptability looks at the impact on Study participants and Study infrastructure; and cost examines the level of effort, personnel, resources, and money.

The three recruitment strategies studied in the Vanguard Study included: 

  • Provider-based Recruitment Strategy: In this strategy, the Study reached potential participants through their existing health care system. Women were given information about the Study through their health care providers (such as a doctor, midwife, or public health nurse) in a familiar and trusted environment. These efforts were supplemented with general outreach activities aimed at raising awareness and recognition of the Study at a broader level.
  • Enhanced Household-based Recruitment Strategy: In this strategy, the Study reached potential participants through door-to-door enrollment at their homes. These household visits  complemented information the families received about the Study through community engagement and media activities.
  • Two-Tiered Recruitment Strategy (High Intensity/Low Intensity): In this strategy, the Study reached potential participants through public media. Participants were enrolled in the low intensity data collection effort, with some participants invited to join a higher intensity data collection. 

A draft of the Main Study Plan and Protocol (PDF 3.5 MB) describes the evolution of, and plans for, the design, and methodology of the NCS and progress to date.

This is the current vanguard study protocol in use (PDF 1 MB).