Abstract:
Background: Overweight and obesity are significant public health concerns that are
prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to
implement and maintain over time. On the other hand, the majority of adolescents in the
United States have a smartphone, representing a huge potential for innovative digitized
interventions, such as weight loss programs delivered via smartphone applications.
Although the number of available smartphone applications is increasing, evidence for
their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to
assess the efficacy of a gamification-based smartphone application for weight
loss in overweight and obese adolescents. The trial is designed to be a phase II, single-
AE vs. BE, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6
months.
Method: The intervention consists of a smartphone application that provides both tracking
and gamification elements, while the control arm consists of an identically designed
application solely with tracking features of health information. The proposed trial will be
conducted in an urban primary care clinic of an academic centre in the United States of
America, with expertise in the management of overweight and obese adolescents. Eligible
adolescents will be followed for 6 months. Changes in body mass index z score from baseline
to 6 months will be the primary outcome. Secondary objectives will explore the effects of
the gamification-based application on adherence, as well as anthropometric, metabolic and
behavioural changes. A required sample size of 108 participants (54 participants per group)
was calculated.
Discussion: The benefits of the proposed study include mid-term effects in weight reduction
for overweight and obese adolescents. The current proposal will contribute to fill a gap
in the literature on the mid-term effects of gamification-based interventions to control
weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated
Standards of Reporting Trials statement.
