NCT00000615

Brief Summary

To develop and test interventions to prevent obesity by decreasing weight gain during the high-risk transitional period from pre-puberty to puberty in African-American girls who are at high risk for developing obesity.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1999

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

August 1, 1999

Completed
3 months 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
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 6, 2021

Status Verified

April 1, 2021

First QC Date

October 27, 1999

Last Update Submit

April 30, 2021

Conditions

Interventions

diet, reducingBEHAVIORAL

Eligibility Criteria

Age8 Years - 10 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
African-American girls, age 8-10 years.

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

Sponsors & Collaborators

Related Publications (26)

  • Matheson DM, Hanson KA, McDonald TE, Robinson TN. Validity of children's food portion estimates: a comparison of 2 measurement aids. Arch Pediatr Adolesc Med. 2002 Sep;156(9):867-71. doi: 10.1001/archpedi.156.9.867.

    PMID: 12197792BACKGROUND
  • Ford BS, McDonald TE, Owens AS, Robinson TN. Primary care interventions to reduce television viewing in African-American children. Am J Prev Med. 2002 Feb;22(2):106-9. doi: 10.1016/s0749-3797(01)00410-x.

    PMID: 11818179BACKGROUND
  • Robinson TN. Television viewing and childhood obesity. Pediatr Clin North Am. 2001 Aug;48(4):1017-25. doi: 10.1016/s0031-3955(05)70354-0.

    PMID: 11494635BACKGROUND
  • Kumanyika SK, Obarzanek E, Robinson TN, Beech BM. Phase 1 of the Girls health Enrichment Multi-site Studies (GEMS): conclusion. Ethn Dis. 2003 Winter;13(1 Suppl 1):S88-91.

    PMID: 12713214BACKGROUND
  • Story M, Sherwood NE, Obarzanek E, Beech BM, Baranowski JC, Thompson NS, Owens AS, Mitchell M, Rochon J. Recruitment of African-American pre-adolescent girls into an obesity prevention trial: the GEMS pilot studies. Ethn Dis. 2003 Winter;13(1 Suppl 1):S78-87.

    PMID: 12713213BACKGROUND
  • Kumanyika SK, Story M, Beech BM, Sherwood NE, Baranowski JC, Powell TM, Cullen KW, Owens AS. Collaborative planning for formative assessment and cultural appropriateness in the Girls health Enrichment Multi-site Studies (GEMS): a retrospection. Ethn Dis. 2003 Winter;13(1 Suppl 1):S15-29.

    PMID: 12713208BACKGROUND
  • Obarzanek E, Pratt CA. Girls health Enrichment Multi-site Studies (GEMS): new approaches to obesity prevention among young African-American girls. Ethn Dis. 2003 Winter;13(1 Suppl 1):S1-5.

    PMID: 12713206BACKGROUND
  • Treuth MS, Sherwood NE, Butte NF, McClanahan B, Obarzanek E, Zhou A, Ayers C, Adolph A, Jordan J, Jacobs DR, Rochon J. Validity and reliability of activity measures in African-American girls for GEMS. Med Sci Sports Exerc. 2003 Mar;35(3):532-9. doi: 10.1249/01.MSS.0000053702.03884.3F.

    PMID: 12618587BACKGROUND
  • Baranowski T, Baranowski JC, Cullen KW, Thompson DI, Nicklas T, Zakeri IE, Rochon J. The Fun, Food, and Fitness Project (FFFP): the Baylor GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S30-9.

    PMID: 12713209BACKGROUND
  • Rochon J, Klesges RC, Story M, Robinson TN, Baranowski T, Obarzanek E, Mitchell M. Common design elements of the Girls health Enrichment Multi-site Studies (GEMS). Ethn Dis. 2003 Winter;13(1 Suppl 1):S6-14.

    PMID: 12713207BACKGROUND
  • Story M, Sherwood NE, Himes JH, Davis M, Jacobs DR Jr, Cartwright Y, Smyth M, Rochon J. An after-school obesity prevention program for African-American girls: the Minnesota GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S54-64.

    PMID: 12713211BACKGROUND
  • Sherwood NE, Taylor WC, Treuth M, Klesges LM, Baranowski T, Zhou A, Pratt C, McClanahan B, Robinson TN, Pruitt L, Miller W. Measurement characteristics of activity-related psychosocial measures in 8- to 10-year-old African-American girls in the Girls Health Enrichment Multisite Study (GEMS). Prev Med. 2004 May;38 Suppl:S60-8. doi: 10.1016/j.ypmed.2003.12.030.

    PMID: 15072860BACKGROUND
  • Treuth MS, Sherwood NE, Baranowski T, Butte NF, Jacobs DR Jr, McClanahan B, Gao S, Rochon J, Zhou A, Robinson TN, Pruitt L, Haskell W, Obarzanek E. Physical activity self-report and accelerometry measures from the Girls health Enrichment Multi-site Studies. Prev Med. 2004 May;38 Suppl:S43-9. doi: 10.1016/j.ypmed.2003.01.001.

    PMID: 15072858BACKGROUND
  • Taylor WC, Baranowski T, Klesges LM, Ey S, Pratt C, Rochon J, Zhou A. Psychometric properties of optimism and pessimism: results from the Girls' Health Enrichment Multisite Studies. Prev Med. 2004 May;38 Suppl:S69-77. doi: 10.1016/j.ypmed.2003.10.015.

    PMID: 15072861BACKGROUND
  • Cullen KW, Watson K, Himes JH, Baranowski T, Rochon J, Waclawiw M, Sun W, Stevens M, Slawson DL, Matheson D, Robinson TN. Evaluation of quality control procedures for 24-h dietary recalls: results from the Girls Health Enrichment Multisite Studies. Prev Med. 2004 May;38 Suppl:S14-23. doi: 10.1016/j.ypmed.2003.10.014.

    PMID: 15072855BACKGROUND
  • Klesges LM, Baranowski T, Beech B, Cullen K, Murray DM, Rochon J, Pratt C. Social desirability bias in self-reported dietary, physical activity and weight concerns measures in 8- to 10-year-old African-American girls: results from the Girls Health Enrichment Multisite Studies (GEMS). Prev Med. 2004 May;38 Suppl:S78-87. doi: 10.1016/j.ypmed.2003.07.003.

    PMID: 15072862BACKGROUND
  • Sherwood NE, Beech BM, Klesges LM, Story M, Killen J, McDonald T, Robinson TN, Pratt C, Zhou A, Cullen K, Baranowski J. Measurement characteristics of weight concern and dieting measures in 8-10-year-old African-American girls from GEMS pilot studies. Prev Med. 2004 May;38 Suppl:S50-9. doi: 10.1016/j.ypmed.2003.12.031.

    PMID: 15072859BACKGROUND
  • Cullen KW, Klesges LM, Sherwood NE, Baranowski T, Beech B, Pratt C, Zhou A, Rochon J. Measurement characteristics of diet-related psychosocial questionnaires among African-American parents and their 8- to 10-year-old daughters: results from the Girls' health Enrichment Multi-site Studies. Prev Med. 2004 May;38 Suppl:S34-42. doi: 10.1016/j.ypmed.2003.05.002.

    PMID: 15072857BACKGROUND
  • Cullen KW, Himes JH, Baranowski T, Pettit J, Stevens M, Slawson DL, Obarzanek E, Murtaugh M, Matheson D, Sun W, Rochon J. Validity and reliability of a behavior-based food coding system for measuring fruit, 100% fruit juice, vegetable, and sweetened beverage consumption: results from the Girls Health Enrichment Multisite Studies. Prev Med. 2004 May;38 Suppl:S24-33. doi: 10.1016/j.ypmed.2003.05.001.

    PMID: 15072856BACKGROUND
  • Baranowski T, Klesges LM, Cullen KW, Himes JH. Measurement of outcomes, mediators, and moderators in behavioral obesity prevention research. Prev Med. 2004 May;38 Suppl:S1-13. doi: 10.1016/j.ypmed.2003.12.029.

    PMID: 15072854BACKGROUND
  • Himes JH, Obarzanek E, Baranowski T, Wilson DM, Rochon J, McClanahan BS. Early sexual maturation, body composition, and obesity in African-American girls. Obes Res. 2004 Sep;12 Suppl:64S-72S. doi: 10.1038/oby.2004.270.

    PMID: 15489469BACKGROUND
  • Adkins S, Sherwood NE, Story M, Davis M. Physical activity among African-American girls: the role of parents and the home environment. Obes Res. 2004 Sep;12 Suppl:38S-45S. doi: 10.1038/oby.2004.267.

    PMID: 15489466BACKGROUND
  • Beech BM, Kumanyika SK, Baranowski T, Davis M, Robinson TN, Sherwood NE, Taylor WC, Relyea G, Zhou A, Pratt C, Owens A, Thompson NS. Parental cultural perspectives in relation to weight-related behaviors and concerns of African-American girls. Obes Res. 2004 Sep;12 Suppl:7S-19S. doi: 10.1038/oby.2004.264.

    PMID: 15489463BACKGROUND
  • Robinson TN, Kraemer HC, Matheson DM, Obarzanek E, Wilson DM, Haskell WL, Pruitt LA, Thompson NS, Haydel KF, Fujimoto M, Varady A, McCarthy S, Watanabe C, Killen JD. Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics. Contemp Clin Trials. 2008 Jan;29(1):56-69. doi: 10.1016/j.cct.2007.04.007. Epub 2007 May 25.

    PMID: 17600772BACKGROUND
  • Robinson TN, Matheson DM, Kraemer HC, Wilson DM, Obarzanek E, Thompson NS, Alhassan S, Spencer TR, Haydel KF, Fujimoto M, Varady A, Killen JD. A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS. Arch Pediatr Adolesc Med. 2010 Nov;164(11):995-1004. doi: 10.1001/archpediatrics.2010.197.

  • Klesges RC, Obarzanek E, Kumanyika S, Murray DM, Klesges LM, Relyea GE, Stockton MB, Lanctot JQ, Beech BM, McClanahan BS, Sherrill-Mittleman D, Slawson DL. The Memphis Girls' health Enrichment Multi-site Studies (GEMS): an evaluation of the efficacy of a 2-year obesity prevention program in African American girls. Arch Pediatr Adolesc Med. 2010 Nov;164(11):1007-14. doi: 10.1001/archpediatrics.2010.196.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesObesity

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Tom Baronowski

    Baylor College of Medicine

  • Robert Klesges

    University of Memphis

  • Thomas Robinson

    Stanford University

  • James Rochon

    George Washington University

  • Mary Story

    University of Minnesota

Study Design

Study Type
interventional
Phase
phase 2
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Medicine

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1999

Study Completion

November 1, 2006

Last Updated

May 6, 2021

Record last verified: 2021-04