CONCLUSIONS Lack of method ologically robust trials gives limited evidence for the success of lifestyle interventions in women with prior GDM .
PURPOSE To systematic ally review lifestyle interventions for women with prior Gestational Diabetes Mellitus ( GDM ) to report study characteristics , intervention design and study quality and explore changes in 1 ) diet , physical activity and sedentary behaviour ; 2 ) anthropometric outcomes and ; 3 ) glycaemic control and diabetes risk .
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
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 design ed for pregnant/postpartum women with GDM and delivered at the health system level . Methods / Design The GEM study is a pragmatic cluster r and omized clinical trial of 44 medical facilities at Kaiser Permanente Northern California r and omly 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 practice s 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 ) . Discussion 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 setting s and to inform policies to promote the prevention of diabetes among women with GDM.Trial registration Clinical Trials.gov number , NCT01344278
CONCLUSIONS Lack of method ologically robust trials gives limited evidence for the success of lifestyle interventions in women with prior GDM .
PURPOSE To systematic ally review lifestyle interventions for women with prior Gestational Diabetes Mellitus ( GDM ) to report study characteristics , intervention design and study quality and explore changes in 1 ) diet , physical activity and sedentary behaviour ; 2 ) anthropometric outcomes and ; 3 ) glycaemic control and diabetes risk .