NCT00000545

Brief Summary

To implement a culturally appropriate school-based, multicenter, randomized trial that promotes healthful eating behaviors and increases physical activity to prevent obesity in pre-adolescent upper elementary American Indian students.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1993

Longer than P75 for phase_2 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1993

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2005

First QC Date

October 27, 1999

Last Update Submit

July 28, 2016

Conditions

Cardiovascular DiseasesSedentary BehaviorsObesity

Interventions

exerciseBEHAVIORAL
dietBEHAVIORAL

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Cohort of pre-adolescent American Indian boys and girls followed in grades 3-5.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (38)

  • Prevention of obesity in American Indian children: the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):745S-824S. doi: 10.1093/ajcn/69.4.745S. No abstract available.

    PMID: 10195596BACKGROUND

  • Caballero B: Introduction. Am J Clin Nutr, 69: 745S-746S, 1999.

    BACKGROUND

  • Story M, Evans M, Fabsitz RR, Clay TE, Holy Rock B, Broussard B. The epidemic of obesity in American Indian communities and the need for childhood obesity-prevention programs. Am J Clin Nutr. 1999 Apr;69(4 Suppl):747S-754S. doi: 10.1093/ajcn/69.4.747S.

    PMID: 10195597BACKGROUND

  • Davis CE, Hunsberger S, Murray DM, Fabsitz RR, Himes JH, Stephenson LK, Caballero B, Skipper B. Design and statistical analysis for the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):760S-763S. doi: 10.1093/ajcn/69.4.760S.

    PMID: 10195599BACKGROUND

  • Lohman TG, Caballero B, Himes JH, Hunsberger S, Reid R, Stewart D, Skipper B. Body composition assessment in American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):764S-766S. doi: 10.1093/ajcn/69.4.764S.

    PMID: 10195600BACKGROUND

  • Gittelsohn J, Evans M, Story M, Davis SM, Metcalfe L, Helitzer DL, Clay TE. Multisite formative assessment for the Pathways study to prevent obesity in American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):767S-772S. doi: 10.1093/ajcn/69.4.767S.

    PMID: 10195601BACKGROUND

  • Stevens J, Cornell CE, Story M, French SA, Levin S, Becenti A, Gittelsohn J, Going SB, Reid R. Development of a questionnaire to assess knowledge, attitudes, and behaviors in American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):773S-781S. doi: 10.1093/ajcn/69.4.773S.

    PMID: 10195602BACKGROUND

  • Weber JL, Cunningham-Sabo L, Skipper B, Lytle L, Stevens J, Gittelsohn J, Anliker J, Heller K, Pablo JL. Portion-size estimation training in second- and third-grade American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):782S-787S. doi: 10.1093/ajcn/69.4.782S.

    PMID: 10195603BACKGROUND

  • Going SB, Levin S, Harrell J, Stewart D, Kushi L, Cornell CE, Hunsberger S, Corbin C, Sallis J. Physical activity assessment in American Indian schoolchildren in the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):788S-795S. doi: 10.1093/ajcn/69.4.788S.

    PMID: 10195604BACKGROUND

  • Davis SM, Going SB, Helitzer DL, Teufel NI, Snyder P, Gittelsohn J, Metcalfe L, Arviso V, Evans M, Smyth M, Brice R, Altaha J. Pathways: a culturally appropriate obesity-prevention program for American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):796S-802S. doi: 10.1093/ajcn/69.4.796S.

    PMID: 10195605BACKGROUND

  • Snyder P, Anliker J, Cunningham-Sabo L, Dixon LB, Altaha J, Chamberlain A, Davis S, Evans M, Hurley J, Weber JL. The Pathways study: a model for lowering the fat in school meals. Am J Clin Nutr. 1999 Apr;69(4 Suppl):810S-815S. doi: 10.1093/ajcn/69.4.810S.

    PMID: 10195607BACKGROUND

  • Helitzer DL, Davis SM, Gittelsohn J, Going SB, Murray DM, Snyder P, Steckler AB. Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):816S-824S. doi: 10.1093/ajcn/69.4.816S.

    PMID: 10195608BACKGROUND

  • Stevens J, Story M, Becenti A, French SA, Gittelsohn J, Going SB, Juhaeri, Levin S, Murray DM. Weight-related attitudes and behaviors in fourth grade American Indian children. Obes Res. 1999 Jan;7(1):34-42. doi: 10.1002/j.1550-8528.1999.tb00388.x.

    PMID: 10023728BACKGROUND

  • Gittelsohn J, Evans M, Helitzer D, Anliker J, Story M, Metcalfe L, Davis S, Iron Cloud P. Formative research in a school-based obesity prevention program for Native American school children (Pathways). Health Educ Res. 1998 Jun;13(2):251-65. doi: 10.1093/her/13.2.251.

    PMID: 10181023BACKGROUND

  • Koehler KM, Cunningham-Sabo L, Lambert LC, McCalman R, Skipper BJ, Davis SM. Assessing food selection in a health promotion program: validation of a brief instrument for American Indian children in the southwest United States. J Am Diet Assoc. 2000 Feb;100(2):205-11. doi: 10.1016/S0002-8223(00)00064-X.

    PMID: 10670393BACKGROUND

  • Teufel NI, Perry CL, Story M, Flint-Wagner HG, Levin S, Clay TE, Davis SM, Gittelsohn J, Altaha J, Pablo JL. Pathways family intervention for third-grade American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):803S-809S. doi: 10.1093/ajcn/69.4.803S.

    PMID: 10195606BACKGROUND

  • Davis SM, Reid R. Practicing participatory research in American Indian communities. Am J Clin Nutr. 1999 Apr;69(4 Suppl):755S-759S. doi: 10.1093/ajcn/69.4.755S.

    PMID: 10195598BACKGROUND

  • Story M, Stevens J, Evans M, Cornell CE, Juhaeri, Gittelsohn J, Going SB, Clay TE, Murray DM. Weight loss attempts and attitudes toward body size, eating, and physical activity in American Indian children: relationship to weight status and gender. Obes Res. 2001 Jun;9(6):356-63. doi: 10.1038/oby.2001.46.

    PMID: 11399782BACKGROUND

  • Lohman TG, Caballero B, Himes JH, Davis CE, Stewart D, Houtkooper L, Going SB, Hunsberger S, Weber JL, Reid R, Stephenson L. Estimation of body fat from anthropometry and bioelectrical impedance in Native American children. Int J Obes Relat Metab Disord. 2000 Aug;24(8):982-8. doi: 10.1038/sj.ijo.0801318.

    PMID: 10951536BACKGROUND

  • Thompson JL, Davis SM, Gittelsohn J, Going S, Becenti A, Metcalfe L, Stone E, Harnack L, Ring K. Patterns of physical activity among American Indian children: an assessment of barriers and support. J Community Health. 2001 Dec;26(6):423-45. doi: 10.1023/a:1012507323784.

    PMID: 11759094BACKGROUND

  • Hunsberger S, Murray D, Davis CE, Fabsitz RR. Imputation strategies for missing data in a school-based multi-centre study: the Pathways study. Stat Med. 2001 Jan 30;20(2):305-16. doi: 10.1002/1097-0258(20010130)20:23.0.co;2-m.

    PMID: 11169604BACKGROUND

  • Story M, Snyder P, Anliker J, Cunningham-Sabo L, Weber JL, Platero H, Stone EJ. Nutrient content of school meals in elementary schools on American Indian reservations. J Am Diet Assoc. 2002 Feb;102(2):253-6. doi: 10.1016/s0002-8223(02)90060-x. No abstract available.

    PMID: 11846122BACKGROUND

  • Lytle LA, Dixon LB, Cunningham-Sabo L, Evans M, Gittelsohn J, Hurley J, Snyder P, Stevens J, Weber J, Anliker J, Heller K, Story M. Dietary intakes of Native American children: findings from the pathways feasibility study. J Am Diet Assoc. 2002 Apr;102(4):555-8. doi: 10.1016/s0002-8223(02)90129-x. No abstract available.

    PMID: 11985417BACKGROUND

  • Caballero B, Clay T, Davis SM, Ethelbah B, Rock BH, Lohman T, Norman J, Story M, Stone EJ, Stephenson L, Stevens J; Pathways Study Research Group. Pathways: a school-based, randomized controlled trial for the prevention of obesity in American Indian schoolchildren. Am J Clin Nutr. 2003 Nov;78(5):1030-8. doi: 10.1093/ajcn/78.5.1030.

    PMID: 14594792BACKGROUND

  • Caballero B, Himes JH, Lohman T, Davis SM, Stevens J, Evans M, Going S, Pablo J; Pathways Study Research Group. Body composition and overweight prevalence in 1704 schoolchildren from 7 American Indian communities. Am J Clin Nutr. 2003 Aug;78(2):308-12. doi: 10.1093/ajcn/78.2.308.

    PMID: 12885714BACKGROUND

  • Story M, Snyder MP, Anliker J, Weber JL, Cunningham-Sabo L, Stone EJ, Chamberlain A, Ethelbah B, Suchindran C, Ring K. Changes in the nutrient content of school lunches: results from the Pathways study. Prev Med. 2003 Dec;37(6 Pt 2):S35-45. doi: 10.1016/j.ypmed.2003.08.009.

    PMID: 14636807BACKGROUND

  • Gittelsohn J, Davis SM, Steckler A, Ethelbah B, Clay T, Metcalfe L, Rock BH. Pathways: lessons learned and future directions for school-based interventions among American Indians. Prev Med. 2003 Dec;37(6 Pt 2):S107-12. doi: 10.1016/j.ypmed.2003.08.001.

    PMID: 14636815BACKGROUND

  • Gittelsohn J, Merkle S, Story M, Stone EJ, Steckler A, Noel J, Davis S, Martin CJ, Ethelbah B. School climate and implementation of the Pathways study. Prev Med. 2003 Dec;37(6 Pt 2):S97-106. doi: 10.1016/j.ypmed.2003.08.010.

    PMID: 14636814BACKGROUND

  • Lohman T, Thompson J, Going S, Himes JH, Caballero B, Norman J, Cano S, Ring K. Indices of changes in adiposity in American Indian children. Prev Med. 2003 Dec;37(6 Pt 2):S91-6. doi: 10.1016/j.ypmed.2003.08.004.

    PMID: 14636813BACKGROUND

  • Steckler A, Ethelbah B, Martin CJ, Stewart D, Pardilla M, Gittelsohn J, Stone E, Fenn D, Smyth M, Vu M. Pathways process evaluation results: a school-based prevention trial to promote healthful diet and physical activity in American Indian third, fourth, and fifth grade students. Prev Med. 2003 Dec;37(6 Pt 2):S80-90. doi: 10.1016/j.ypmed.2003.08.002.

    PMID: 14636812BACKGROUND

  • Stevens J, Story M, Ring K, Murray DM, Cornell CE, Juhaeri, Gittelsohn J. The impact of the Pathways intervention on psychosocial variables related to diet and physical activity in American Indian schoolchildren. Prev Med. 2003 Dec;37(6 Pt 2):S70-9. doi: 10.1016/j.ypmed.2003.08.012.

    PMID: 14636811BACKGROUND

  • Going S, Thompson J, Cano S, Stewart D, Stone E, Harnack L, Hastings C, Norman J, Corbin C. The effects of the Pathways Obesity Prevention Program on physical activity in American Indian children. Prev Med. 2003 Dec;37(6 Pt 2):S62-9. doi: 10.1016/j.ypmed.2003.08.005.

    PMID: 14636810BACKGROUND

  • Himes JH, Ring K, Gittelsohn J, Cunningham-Sabo L, Weber J, Thompson J, Harnack L, Suchindran C. Impact of the Pathways intervention on dietary intakes of American Indian schoolchildren. Prev Med. 2003 Dec;37(6 Pt 2):S55-61. doi: 10.1016/j.ypmed.2003.08.003.

    PMID: 14636809BACKGROUND

  • Gunnarsson LG, Bodin L, Soderfeldt B, Axelson O. A case-control study of motor neurone disease: its relation to heritability, and occupational exposures, particularly to solvents. Br J Ind Med. 1992 Nov;49(11):791-8. doi: 10.1136/oem.49.11.791.

    PMID: 1463680BACKGROUND

  • Stone EJ, Norman JE, Davis SM, Stewart D, Clay TE, Caballero B, Lohman TG, Murray DM. Design, implementation, and quality control in the Pathways American-Indian multicenter trial. Prev Med. 2003 Dec;37(6 Pt 2):S13-23. doi: 10.1016/j.ypmed.2003.08.006.

    PMID: 14636805BACKGROUND

  • Story M, Stevens J, Himes J, Stone E, Rock BH, Ethelbah B, Davis S. Obesity in American-Indian children: prevalence, consequences, and prevention. Prev Med. 2003 Dec;37(6 Pt 2):S3-12. doi: 10.1016/j.ypmed.2003.08.008.

    PMID: 14636804BACKGROUND

  • Cunningham-Sabo L, Snyder MP, Anliker J, Thompson J, Weber JL, Thomas O, Ring K, Stewart D, Platero H, Nielsen L. Impact of the Pathways food service intervention on breakfast served in American-Indian schools. Prev Med. 2003 Dec;37(6 Pt 2):S46-54. doi: 10.1016/j.ypmed.2003.08.007.

    PMID: 14636808BACKGROUND

  • Weber JL, Lytle L, Gittelsohn J, Cunningham-Sabo L, Heller K, Anliker JA, Stevens J, Hurley J, Ring K. Validity of self-reported dietary intake at school meals by American Indian children: the Pathways Study. J Am Diet Assoc. 2004 May;104(5):746-52. doi: 10.1016/j.jada.2004.02.029.

    PMID: 15127059BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesSedentary BehaviorObesity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • H. Stevens

    University of North Carolina

Study Design

Study Type
interventional
Phase
phase 2
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1993

Study Completion

July 1, 2002

Last Updated

July 29, 2016

Record last verified: 2005-12