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After-School to Pre-Sleep Energy Restriction for obesity in primary school children in grades 3-6: protocol for a
Xuemei Xie1, Ying Lv1, Xiyi Li2
1Department of Endocrinology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China.
Background:
The rising prevalence of childhood obesity has become a major global public health concern. Dietary intervention remains the cornerstone of pediatric obesity management. However, both conventional all-day energy-restricted diets and time-restricted eating have limitations in school-aged children. Studies indicate that excessive evening caloric intake is closely associated with obesity. This trial aims to evaluate the efficacy of an After-School to Pre-Sleep Energy Restriction (ASER) strategy compared with standard dietary intervention for pediatric obesity management.
Methods And Analysis:
This study is a prospective, randomized, open-label, parallel-group trial. We plan to enroll 164 obese children from grades 3 to 6, who will be stratified by age, gender, and BMI z-score and randomly assigned in a 1:1 ratio to either the ASER group or the control group. The 24-week intervention consists of an intensive phase (weeks 0-12) followed by a maintenance phase (weeks 13-24). The primary endpoint is the between-group difference in BMI z-score (BMIz) change at week 12. Secondary endpoints include within-group BMIz changes at week 12; between-group and within-group BMIz changes at week 24; between-group and within-group changes in %BMI95, body composition, growth parameters, cardiometabolic markers, and psychobehavioral metrics at both 12 and 24 weeks; and between-group differences in the incidence of adverse events at weeks 12 and 24.
Ethics And Dissemination:
This study was approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (Approval No.: 2025-K0254). Written informed consent will be obtained from legal guardians, and assent will be obtained from child participants prior to enrollment. Study findings will be published in peer-reviewed journals.
Trial Registration:
The trial was prospectively registered on 3 September 2025, prior to the first participant enrollment, with the Chinese Clinical Trial Registry (ChiCTR2500108702). The URL of the specific trial registry record is https://www.chictr.org.cn/showproj.html?proj=275435 .
