OBJECTIVE: To assess the effectiveness of an exercise intervention, in addition to standard care, in preventing or delaying insulin prescription in women with gestational diabetes mellitus (GDM). DESIGN: Randomised controlled trial. SETTING: University hospital. POPULATION: Pregnant women at 25 to 35 weeks of gestation diagnosed with GDM. METHODS: Women in the intervention group participated in weekly, supervised, 30 to 45 min exercise sessions and were encouraged to accumulate more than 5000 steps per day, tracked by a pedometer, in addition to receiving usual care. The control group received standard care only. MAIN OUTCOME MEASURE: Insulin prescription. RESULTS: From February 2008 through April 2013, 109 women were randomized into the intervention group (n = 57) or the usual care group (n = 52). Two women in the intervention group were excluded from the analysis (one was randomised in error and one was lost to follow-up). Six women never attended the exercise sessions, and two attended fewer than two sessions. However, two-third of women were considered as compliant to the intervention (attended more than 50% of sessions and/or averaged more than 5000 steps/day). The incidence of insulin prescription did not differ between the groups: 31 women (56%) in the intervention group versus 24 women (46%) in the control group (RR 1.22, 95% CI 0.84 to 1.78). The median time from randomization to insulin prescription was also similar between groups (14 days in the intervention group and 13 days in the control group). CONCLUSION: This study did not demonstrate that an exercise program reduces or delays insulin prescription in women with GDM. Low adherence to the intervention, a small sample size, and the short duration of the program may explain the lack of observed benefit. REGISTERED: At clinicaltrials.gov, NCT03174340, 02/06/2017.

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