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Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus [with consumer summary]
Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR
American Journal of Obstetrics and Gynecology 2023 Aug;229(2):158.e1-158.e14
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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*

BACKGROUND: Preconception lifestyle intervention holds potential for reducing gestational diabetes mellitus, but clinical trial data are lacking. OBJECTIVE: This study aimed to determine the effects of a prepregnancy weight loss intervention on gestational diabetes mellitus recurrence in women with overweight/obesity and previous gestational diabetes mellitus. STUDY DESIGN: A 2-site, randomized controlled trial comparing a prepregnancy lifestyle intervention with educational control was conducted between December 2017 and February 2022. A total of 199 English- and Spanish-speaking adults with overweight/obesity and previous gestational diabetes mellitus were randomized to a 16-week prepregnancy lifestyle intervention with ongoing treatment until conception or educational control. The primary outcome was gestational diabetes mellitus recurrence. Analyses excluded 6 participants who conceived but did not have gestational diabetes mellitus ascertained by standard methods. RESULTS: In the 63 (33%) women who conceived and had gestational diabetes mellitus ascertained (Ns = 38/102 (37%) intervention versus 25/91 (28.0%) control; p = 0.17), those in the intervention group had significantly greater weight loss at 16 weeks compared with controls (4.8 (3.4 to 6.0) versus 0.7 (-0.9 to 2.3) kg; p = 0.001) and a greater proportion lost >= 5% of body weight (50.0% (17/34) versus 13.6% (3/22); p = 0.005). There was no significant difference in the incidence of gestational diabetes mellitus recurrence between the intervention (57.9% (ns = 23/38)) and the control group (44.0% (ns = 11/25); odds ratio 1.8 (0.59 to 5.8)). Independent of group, greater prepregnancy weight loss predicted 21% lower odds of gestational diabetes mellitus recurrence (odds ratio, 0.79 (0.66 to 0.94); p = 0.008). A >= 5% weight loss before conception reduced the odds of gestational diabetes mellitus recurrence by 82% (odds ratio, 0.18 (0.04 to 0.88); p = 0.03). CONCLUSION: Lifestyle intervention produced considerable prepregnancy weight loss but did not affect gestational diabetes mellitus rates. Given that the conception rate was 50% lower than expected, this study was underpowered.
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