title: A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study.
abstract: BACKGROUND
  Women with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level.
  
  
  METHODS
  The GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks).
  
  
  CONCLUSIONS
  There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.
authors.affiliation: Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, USA. Assiamira.Ferrara@kp.org.
authors.forename: Assiamira
authors.initials: A
authors.lastname: Ferrara
authors.forename: Monique M
authors.initials: MM
authors.lastname: Hedderson
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Albright
authors.forename: Susan D
authors.initials: SD
authors.lastname: Brown
authors.forename: Samantha F
authors.initials: SF
authors.lastname: Ehrlich
authors.forename: Bette J
authors.initials: BJ
authors.lastname: Caan
authors.forename: Barbara
authors.initials: B
authors.lastname: Sternfeld
authors.forename: Nancy P
authors.initials: NP
authors.lastname: Gordon
authors.forename: Julie A
authors.initials: JA
authors.lastname: Schmittdiel
authors.forename: Erica P
authors.initials: EP
authors.lastname: Gunderson
authors.forename: Ashley A
authors.initials: AA
authors.lastname: Mevi
authors.forename: Ai-Lin
authors.initials: AL
authors.lastname: Tsai
authors.forename: Jenny
authors.initials: J
authors.lastname: Ching
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Crites
authors.forename: Charles P
authors.initials: CP
authors.lastname: Quesenberry
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002140:California; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D016640:Diabetes, Gestational / Q000503:physiopathology / Q000517:prevention & control*; D004032:Diet; D037001:Directive Counseling; D005260:Female; D006293:Health Promotion / Q000191:economics / Q000379:methods*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008019:Life Style; D009043:Motor Activity; D010353:Patient Education as Topic; D011181:Postnatal Care; D011247:Pregnancy; D011295:Prenatal Care; D012107:Research Design; D013689:Telephone; D015430:Weight Gain; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents