BACKGROUND: Obesity is an important risk factor for obstructive sleep apnea (OSA). This study aimed to assess the effect of weight reduction through lifestyle modification program (LMP) on patients with moderate to severe OSA. METHODS: This was a parallel group, randomized controlled trial. Altogether 104 patients with moderate to severe OSA diagnosed on portable home sleep monitoring were randomized to receive a dietician-led- LMP or usual care for 12 months. The primary outcome was reduction of apnea hypopnea index (AHI) at 12 months as assessed by portable home sleep monitoring. RESULTS: In the intention to treat analysis (ITT), LMP (n = 61) was more effective in reducing AHI from baseline (16.9% less events in LMP group versus 0.6% more events in control group, p = 0.011). LMP was more effective in reducing body mass index (BMI) (-1.8kg, 6.0% of the initial BMI; -0.6kg, 2.0% of the initial BMI in control group, p < 0.001). The reduction in daytime sleepiness as assessed by Epworth Sleepiness Score was not significant in ITT but was more in LMP group (-3.5 in LMP group versus -1.1 in control group, p = 0.004) by treatment per protocol analysis. There was modest improvement in mental health in SF-36. The eating behavior was improved with increased intake of protein and fiber. These changes were observed 4 months after the initial intensive diet counselling and persisted at 12 months. CONCLUSION: LMP was effective in reducing the severity of OSA and daytime sleepiness. The beneficial effect was sustained in 12 months. CLINICAL TRIAL REGISTRATION: NCT01384760.

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