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Results from a European multicenter randomized trial of physical activity and/or healthy eating to reduce the risk of gestational diabetes mellitus: the DALI lifestyle pilot |
Simmons D, Jelsma JGM, Galjaard S, Devlieger R, van Assche A, Jans G, Corcoy R, Adelantado JM, Dunne F, Desoye G, Harreiter J, Kautzky-Willer A, Damm P, Mathiesen ER, Jensen DM, Andersen LL, Lapolla A, Dalfra M, Bertolotto A, Wender-Ozegowska E, Zawiejska A, Hill D, Rebollo P, Snoek FJ, van Poppel MN |
Diabetes Care 2015 Sep;38(9):1650-1656 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; 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* |
OBJECTIVE: Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating (HE), physical activity (PA), and both HE and PA (HE+PA)) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS: Pregnant women at risk for GDM (BMI >= 29 kg/m2) from nine European countries were invited to undertake a 75g oral glucose tolerance test before 20 weeks' gestation. Those without GDM were randomized to HE, PA, or HE+PA. Women received five face-to-face and four optional telephone coaching sessions, based on the principles of motivational interviewing. A gestational weight gain (GWG) < 5 kg was targeted. Coaches received standardized training and an intervention toolkit. Primary outcome measures were GWG, fasting glucose, and insulin sensitivity (HOMA) at 35 to 37 weeks. RESULTS: Among the 150 trial participants, 32% developed GDM by 35 to 37 weeks and 20% achieved GWG < 5 kg. HE women had less GWG (-2.6 kg (95% CI -4.9 to -0.2); p = 0.03) and lower fasting glucose (-0.3 mmol/L (-0.4 to -0.1); p = 0.01) than those in the PA group at 24 to 28 weeks. HOMA was comparable. No significant differences between HE+PA and the other groups were observed. CONCLUSIONS: An antenatal HE intervention is associated with less GWG and lower fasting glucose compared with PA alone. These findings require a larger trial for confirmation but support the use of early HE interventions in obese pregnant women.
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