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The comparative effectiveness of diabetes prevention strategies to reduce postpartum weight retention in women with gestational diabetes mellitus: the Gestational diabetes' Effects on Moms (GEM) cluster randomized controlled trial |
Ferrara A, Hedderson MM, Brown SD, Albright CL, Ehrlich SF, Tsai A-L, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Herman WH, Ching J, Crites Y, Quesenberry CP |
Diabetes Care 2016 Jan;39(1):65-74 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
RESEARCH DESIGN AND METHODS: This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of (1) reaching pregravid weight if pregravid BMI < 25.0 kg/m2 or (2) losing 5% of pregravid weight if BMI >= 25.0 kg/m2; and pregravid to postpartum weight change. RESULTS: On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio (OR) 1.28 (95% CI 1.10 to 1.47)). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 versus 22.4%; OR 1.17 (1.01 to 1.36)) and 6 months (30.6 versus 23.9%; OR 1.45 (1.14 to 1.83)). Condition differences were reduced at 12 months (33.0 versus 28.0%; OR 1.25 (0.96 to 1.62)). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg (SD 5.5) versus 0.95 kg (5.5); mean condition difference -0.64 kg (95% CI -1.13 to -0.14)) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week (4.9 to 25.8)). CONCLUSIONS: A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. OBJECTIVE: To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention.
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