The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. In this abstract, we show the baseline data and the evaluation its comparability in both groups.Design and method:
A randomized, double-blind, multicenter, parallel group clinical trial was carried out. A total of 833 subjects were included (415 in intervention group and 418 in control group). Counseling common to both groups (control (CG) and intervention (IG)) was provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover received a training on the use of a smartphone application designed to promote a healthy diet and increased physical activity for three months. The main endpoints were the changes in physical activity, assessed by accelerometer and the 7 day Physical Activity Recall interview, and adaptation to the Mediterranean diet.Results:
The mean age was 51.4 in IG and 52.3 in CG; women was 64 and 60% respectively with no difference between groups. No differences were found in marital status, educational level and employment status. We also found no difference in clinical (body mass index, waist circumference and blood pressure) biochemical (glucose and lipids) and hemodynamic variables analyzed. The mean dose of physical activity was 865.8 METS / minute/week in CG and 864.6 in IG, being active (> 450 METS / min / week) 48.6 and 49.2 respectively (p > 0.05). The count / minute by accelerometer were 65.9 in CG and 64.4 in IG (p > 0.05). The mean number of criteria compliments of Mediterranean diet was 7.2 and 7.4 and the percent subject with correct compliment (> = 9) were 28% in CG and 34% in IG respectively (p > 0.05).Conclusions:
The comparability of both groups at baseline is appropriate, since it is not found significant differences in either the main variables or other demographic, clinical and laboratory parameters that could be confounding.