Short-Term Effectiveness of a Mobile Phone App for Increasing Physical Activity and Adherence to the Mediterranean Diet in Primary Care: A Randomized Controlled Trial (EVIDENT II Study)

BACKGROUND The use of mobile phone apps for improving lifestyles has become generalized in the population, although little is still known about their effectiveness in improving health. OBJECTIVE We evaluate the effect of adding an app to standard counseling on increased physical activity (PA) and adherence to the Mediterranean diet, 3 months after implementation. METHODS A randomized, multicenter clinical trial was carried out. A total of 833 participants were recruited in six primary care centers in Spain through random sampling: 415 in the app+counseling group and 418 in the counseling only group. Counseling on PA and the Mediterranean diet was given to both groups. The app+counseling participants additionally received training in the use of an app designed to promote PA and the Mediterranean diet over a 3-month period. PA was measured with the 7-day Physical Activity Recall (PAR) questionnaire and an accelerometer; adherence to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener questionnaire. RESULTS Participants were predominantly female in both the app+counseling (249/415, 60.0%) and counseling only (268/418, 64.1%) groups, with a mean age of 51.4 (SD 12.1) and 52.3 (SD 12.0) years, respectively. Leisure-time moderate-to-vigorous physical activity (MVPA) by 7-day PAR increased in the app+counseling (mean 29, 95% CI 5-53 min/week; P=.02) but not in the counseling only group (mean 17.4, 95% CI -18 to 53 min/week; P=.38). No differences in increase of activity were found between the two groups. The accelerometer recorded a decrease in PA after 3 months in both groups: MVPA mean -55.3 (95% CI -75.8 to -34.9) min/week in app+counseling group and mean -30.1 (95% CI -51.8 to -8.4) min/week in counseling only group. Adherence to the Mediterranean diet increased in both groups (8.4% in app+counseling and 10.4% in counseling only group), with an increase in score of 0.42 and 0.53 points, respectively (P<.001), but no difference between groups (P=.86). CONCLUSIONS Leisure-time MVPA increased more in the app+counseling than counseling only group, although no difference was found when comparing the increase between the two groups. Counseling accompanied by printed materials appears to be effective in improving adherence to the Mediterranean diet, although the app does not increase adherence. CLINICALTRIAL Clinicaltrials.gov NCT02016014; https://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/6mnopADbf).