Effectiveness of PUSH notifications from a mobile app for improving the body composition of overweight or obese women: a protocol of a three-armed randomized controlled trial

BACKGROUND: The penetration level of mobile technology has grown exponentially and is part of our lifestyle, at all levels. The use of the smartphone has opened up a new horizon of possibilities in the treatment of health, not in vain, around 40% of existing applications are linked to the mHealth segment. Taking advantage of this circumstance to study new approaches in the treatment of obesity and prescription of physical activity is growing interest in the field of health. The primary outcome (obese adult women) will be assessed according to age, fitness status, weight, and body composition status. Data will be collected at enrollment and weekly during 6 months of intervention on dietary practices, physical activity, anthropometry, and body composition. Analysis of effect will be performed comparing the outcomes between intervention and control arms. The message delivery is in progress. METHODS: A 3-arm clinical trial was established. A series of quantitative and qualitative measures were used to evaluate the effects of self-weighing and the establishment of objectives to be reached concerning the prescription of physical activity. At the end of this pilot study, a set of appropriate measures and procedures were identified and agreed upon to determine the effectiveness of messaging in the form of PUSH technology. The results were recorded and analyzed to begin a randomized controlled trial to evaluate the effectiveness of the proposed methodology. CONCLUSIONS: The study is anticipated to establish feasibility of using PUSH notifications to evaluate whether or not an intervention of 6 months, directed by a team formed by Dietician-Nutritionist and nursing professionals, by means of an application for Smartphone and a personal consultation, improves the body composition of adult women with a fat percentage equal to or higher than 30% at the beginning of the study. TRIAL REGISTRATION: Clinical Trials ID: NCT03911583. First Submitted: April 9, 2019. Ethical oversight is provided by the Bioethical Committee of Córdoba University and registered in the platform clinicaltrials.gov. The results will be published in peer-reviewed journals and analysis data will be made public.