Impact of Enhanced Family Education on BMI Changes in Children and Adolescents With Overweight or Obesity: Study Protocol for a City-Wide Cluster Randomized Controlled Trial.

Background: The prevalence of obesity among children and adolescents has become a critical global public health issue, particularly in China, with significant increases observed over the past few decades. Despite regular surveillance for overweight and obesity in the past decades, there have been no annual reports provided to parents, resulting in a significant underrecognition of this issue. Early intervention and enhanced family-based educational intervention are necessary to address this growing problem. Objective: This protocol aims to evaluate the effectiveness of an enhanced family-based educational intervention in reducing overweight and obesity among school-age children and adolescents. Methods: This study uses a stratified cluster randomized controlled trial design involving 40 schools from 4 cities in Guangdong Province, selected based on economic levels and overweight and obesity prevalence. Schools will be randomly assigned to intervention or control groups. The intervention group receives an enhanced family-based educational intervention on obesity prevention, including health reports and educational materials. The control group continues with regular practices, including routine physical examinations, general health education activities, and school-based physical activity programs. The intervention spans 9 months, followed by a 3-month follow-up. Data on BMI, waist circumference, and waist-to-height ratio are collected at baseline and after 12 months to assess the potential effectiveness of the intervention. Results: This trial was funded in January 2024 and registered in the Chinese Clinical Trial Registry on November 5, 2024. Recruitment was completed in December 2024, with 20 schools enrolled in each of the intervention and control groups. Baseline data collection was completed during the 2024 fall semester, and follow-up data collection continued through December 2025. Data analysis will start after completion of the 12-month assessments. The study findings are expected to be published in 2026. Conclusions: This study protocol addresses the urgent need for effective interventions to combat the increasing prevalence of childhood and adolescent obesity in Guangdong Province. Given the significant underrecognition of the need for consistent reporting to parents, the proposed enhanced family-based educational intervention aims to fill this gap by raising parental awareness and promoting healthier lifestyles among children and adolescents. If successful, this approach could significantly reduce the risk of overweight and obesity in Chinese populations, which account for approximately one-fifth of the world's population. The findings will provide insights into the efficacy of family-centered interventions and underscore the importance of integrating routine parental reporting into existing surveillance programs.