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Regular exercise to prevent the recurrence of gestational diabetes mellitus: a randomized controlled trial |
Guelfi KJ, Ong MJ, Crisp NA, Fournier PA, Wallman KE, Grove JR, Doherty DA, Newnham JP |
Obstetrics and Gynecology 2016 Oct;128(4):819-827 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: 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* |
OBJECTIVE: To investigate the effect of a supervised home-based exercise program on the recurrence and severity of gestational diabetes mellitus (GDM) together with other aspects of maternal health and obstetric and neonatal outcomes. METHODS: This randomized controlled trial allocated women with a history of GDM to an exercise intervention (14-week supervised home-based stationary cycling program) or to a control group (standard care) at 13 +/- 1 weeks of gestation. The primary outcome was a diagnosis of GDM. Secondary outcomes included maternal fitness, psychological well-being, and obstetric and neonatal outcomes. A sample size of 180 (90 in each group) was required to attain 80% power to detect a 40% reduction in the incidence of GDM. RESULTS: Between June 2011 and July 2014, 205 women provided written consent and completed baseline assessments. Of these, 33 (16%) were subsequently excluded as a result of an elevated baseline oral glucose tolerance test (OGTT), leaving 172 randomized to exercise (n = 85) or control (n = 87). Three women miscarried before the assessment of outcome measures (control = 2; exercise = 1). All remaining women completed the postintervention OGTT. The recurrence rate of GDM was similar between groups (control 40% (n = 34); exercise 40.5% (n = 34); p = 0.95) and the severity of GDM at diagnosis was unaffected by the exercise program with similar glucose and insulin responses to the OGTT (glucose 2 hours post-OGTT 7.7 +/- 1.5 compared with 7.6 +/- 1.6 mmol/L; p > 0.05). Maternal fitness was improved by the exercise program (p < 0.01) and psychological distress was reduced (p = 0.02). There were no differences in obstetric and neonatal outcomes between groups (p > 0.05). CONCLUSION: Supervised home-based exercise started at 14 weeks of gestation did not prevent the recurrence of GDM; however, it was associated with important benefits for maternal fitness and psychological well-being. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01283854.
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