Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

BACKGROUND Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named "HAPPY ME," which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10-12 years of age using HAPPY ME. METHODS A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. CONCLUSIONS The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.