278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups.
General characteristics of the study communities and participants are shown in Table 2. The study communities are located in Lakeville, MN, USA and Cedar Rapids, IA, USA. Lakeville, MN is a community of approximately 50,000 and is considered the southern-most suburb of Minneapolis-St. Paul. Cedar Rapids, IA has a population of approximately 125,000 and is located in east-central IA. These two community school districts comprising ten elementary schools (6 in Cedar Rapids and 4 in Lakeville) were chosen to participate in the study. Schools were matched within district based on average school enrollment and percent free/reduced-cost lunch, and randomly assigned to either an experimental (3 in Cedar Rapids and 2 in Lakeville) or control (3 in Cedar Rapids and 2 in Lakeville) condition. A total of 1359 children were enrolled in the study out of 2091 possible, a 65% participation rate. Participation rates were similar between experimental and control schools, with 685 out of 1019 children participating in experimental schools (67% participation) and 674 out of 1072 children participating in control schools (63% participation). To have sufficient power to detect a difference of 1000 steps/day (standard deviation 2500 steps/day) or 2 fruit and vegetable servings per week (standard deviation 5 servings per week) or 5 hours of screen time per week (standard deviation 12 hours per week) between intervention and control group with power 0.80 and alpha 0.05, a minimum of 200 subjects was needed. Parental consent and child assent were obtained prior to data collection. Teachers also provided consent to complete teacher surveys during the study. All aspects of the study protocol were approved by the University of Minnesota Human Subjects Committee. 2b1af7f3a8