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United States Department of Agriculture

Agricultural Research Service

Title: COMMON DESIGN ELEMENTS OF THE GIRLS HEALTH ENRICHMENT MULTI-SITE STUDIES (GEMS)

Authors
item Rochon, James - GEORGE WASHINGTON UNIV
item Klesges, Robert - UNIV OF TENNESSEE-MEMPHIS
item Story, Mary - UNIV OF MINNESOTA
item Robinson, Thomas - STANFORD UNIVERSITY
item Baranowski, Thomas
item Obarzanek, Eva - NAT HEART,BLOOD&LUNG INST
item Mitchell, Megan - GEORGE WASHINGTON UNIV

Submitted to: Ethnicity and Disease
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: February 1, 2003
Publication Date: November 1, 2003
Citation: Rochon, J., Klesges, R.C., Story, M., Robinson, T.N., Baranowski, T., Obarzanek, E., Mitchell, M. 2003. Common design elements of the girls health enrichment multi-site studies (GEMS). Ethnicity and Disease. 13(1 Suppl 1):S6-S14.

Interpretive Summary: The purpose of this paper is to describe the common design elements of the GEMS Phase 1 pilot studies. The Girls health Enrichment Multi-site Studies (GEMS) was a multi-center research program created for the purpose of testing interventions designed to prevent excess weight gain by African-American girls, as they enter and proceed through puberty. This report presents the basic study design, a brief overview of the interventions, the measurements taken and their rationale, and procedures both for compiling the collaborative database, and performing site-specific analyses.

Technical Abstract: The Girls health Enrichment Multi-site Studies (GEMS) was a multi-center research program created for the purpose of testing interventions designed to prevent excess weight gain by African-American girls, as they enter and proceed through puberty. However, GEMS was not a "multi-center clinical trial" in the usual sense. Although these studies applied similar eligibility criteria, observed a similar follow-up schedule, and followed a similar measurement protocol, important differences existed, as well. Each field center developed its own intervention(s) and corresponding control, and tailored its study to the specific hypothesis being tested. Therefore, the study populations were somewhat different, with recruitment strategies that varied accordingly, and supplemental evaluations appropriate to the specific interventions were conducted on a site-specific basis. The purpose of this paper is to describe the common design elements of the GEMS Phase 1 pilot studies. This report presents the basic study design, a brief overview of the interventions, the measurements taken and their rationale, and procedures both for compiling the collaborative database, and performing site-specific analyses.

Last Modified: 10/31/2014
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