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This supplement presents the overall design and results of the feasibility phase of Pathways, a randomized intervention trial for the primary prevention of obesity in American Indian children. Pathways is a school-based, multidisciplinary program that includes physical activity, diet behaviors, classroom curriculum, and family involvement. The study design and the measurement instruments and intervention components were developed and tested during a 3 y feasibility phase that took place between 1994 and 1996. As this supplement goes to press, the 5 y, full-scale phase is being initiated, involving > 2000 third-grade children in 41 schools in 7 American Indian communities.
Most of the Pathways schools are public schools, located in or near American Indian reservations. A few are parochial schools or schools administered by the Bureau of Indian Affairs. All follow a similar curriculum, as defined by the school boards of each state.
Pathways will evaluate the effectiveness of a comprehensive, school-based intervention for reducing the rate of obesity (measured as percentage body fat) in elementary schoolchildren. The average percentage body fat in children in the control and intervention schools will be compared after 3 consecutive years of intervention. A number of secondary aims will be addressed to evaluate the effect of the program on physical activity; knowledge, attitudes, and behavior; dietary intake; and other variables. The study also includes an extensive process evaluation component, which will help elucidate the positive and negative aspects of delivering such a program in the school setting.
That childhood obesity is increasing at an alarming rate is unquestionable, as are the adverse health consequences of obesity in adults. It is also generally agreed that, because of the poor long-term success of most obesity treatment regimens, a reduction in the prevalence of obesity will require systematic efforts in the area of primary prevention. There is no clear consensus, however, on what would be the most effective approach for a primary obesity-prevention program, specifically one aimed at school-age children. Several studies reported success in modifying certain risk factors for obesity in children, but these were usually small in size and narrow in scope, and thus of limited generalizability. Similarly, insights gained from pediatric weight-management programs, which target obese children, may not always be relevant to primary prevention programs aimed at an entire population of children. Furthermore, the high cost in time and money that prevention trials demand limits the number of such studies that can realistically be planned. To our knowledge, Pathways is the first randomized clinical trial in the United States that evaluates a comprehensive primary prevention program for childhood obesity.
The decision to focus a childhood obesity prevention program on American Indian communities is a logical response to the alarming trends of obesity and diabetes in these communities, which suffer from these conditions at much higher rates than the general US population. But focusing the program on American Indian communities also posed several challenges. First, it became clear that a program such as Pathways could not be developed without a level of American Indian involvement that went well beyond informed consent, requiring the active participation in the development and testing of all intervention and measurement components. This required that the scientists develop a genuine partnership (and share control of the study) with nonscientist American Indians. For this to occur, mechanisms had to be developed to allow full participation of American Indians in the decision-making process. Pathways responded to this challenge by establishing a unique steering committee that includes American Indians elected by all the American Indians working in the study who are full voting members but are not principal investigators. The second challenge was for American Indians from the different tribes included in the study to find a common cultural ground from which to develop an intervention that would be culturally acceptable to all tribes. Furthermore, this had to be achieved without diminishing the scientific rigor of the study protocol. Third, the study components had to undergo an approval process much more extensive than in the usual multicenter study. In addition to the 5 university internal review boards and the National Heart, Lung, and Blood Institute of the National Institutes of Health, the sponsoring agency, each protocol had to be reviewed and approved by tribal councils, health authorities, school boards, principals, teachers, and parents. This process, although time-consuming, added much to our understanding of the expectations and cultural context of research in American Indian communities and in public schools and will undoubtedly help in the sustainability of similar intervention programs in the future.
Most of the components of Pathways were developed specifically for this study. There are few instruments and materials properly validated for use in third-grade children and none for American Indian children of elementary school age. Unquestionably, however, we could not have developed some of the components of the Pathways intervention within the time and resources allowed without relying on the excellent earlier work of other child health programs, particularly CATCH (Children and Adolescent Trial for Cardiovascular Health) and SPARK (Sports, Play and Active Recreation for Kids), both of which were also developed with funding from the National Heart, Lung, and Blood Institute.
The articles that follow describe major areas of the Pathways study: background and rationale; study design and statistical analysis strategy, measurement procedures (body composition, physical activity, behavior and knowledge, and dietary intake), intervention components, and process evaluation procedures. We trust these reports will be of use to researchers and health authorities seeking to develop similar prevention programs. Much more work is needed before a proven, effective intervention package to prevent obesity in the school setting can be generally recommended. Pathways is a first step in that direction, and we look forward to refining it and learning more about its constraints from the full-scale implementation and from the work and comments of colleagues.
We named our study Pathways because of our conviction that, unlike preventing an infectious disease with a single vaccine shot, preventing obesity and its complications is a long journey. No program or health professional can walk that road for us, but they can point the course and help us clear the path. This is, in fact, the ultimate mission of Pathways.
We express our appreciation to the many parents, teachers, and children who generously donated their time (and patience) to evaluate and test each component of the program. We also acknowledge the generous advice and comments we received over these years from the members of the Pathways Protocol Review Committee. The editorial support provided by Denise Lee is also appreciated. Finally, we thank the Bristol-Myers Squibb Co, Mead Johnson Nutritional Group, for providing support for the publication of this supplement, as part of an unrestricted award to the Johns Hopkins Center for Human Nutrition. The Pathways project is funded by grants U01-HL-50867, U01-HL-50905, U01-HL-50885, U01-HL-50907, and U01-HL-50869 from the National Heart, Lung, and Blood Institute.
This article has been cited by other articles:
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  T. J. Mendenhall and W. J. Doherty Partners in Diabetes: Action research in a primary care setting Action Research, December 1, 2007; 5(4): 378 - 406. [Abstract] [PDF]
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 B. Caballero, T. Clay, S. M Davis, B. Ethelbah, B. H. Rock, T. Lohman, J. Norman, M. Story, E. J Stone, L. Stephenson, et al. Pathways: a school-based, randomized controlled trial for the prevention of obesity in American Indian schoolchildren Am. J. Clinical Nutrition, November 1, 2003; 78(5): 1030 - 1038. [Abstract] [Full Text] [PDF]
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