BACKGROUND: The increasing prevalence of obesity is associated with the increase in type 2 diabetes, dyslipidemia and hypertension among children. The MyBFFatschool study aimed to assess the effectiveness of a 6-month intervention program on the cardiometabolic markers of the overweight and obese primary schoolchildren. METHODS: MyBFFatschool is a cluster randomized controlled trial involving 23 of 1196 government schools in Malaysia. Schoolchildren aged 9 to 11 years with a body mass index (BMI) adjusted for gender and age (BMI z-score) > + 1 SD were recruited. This program (incorporating physical activity, nutrition and psychological components) was conducted during school hours. The effect of the intervention on cardiometabolic status was determined both within and between groups using repeated analysis of variance together with analysis of covariance. Out of 1397 schoolchildren, 683 (intervention = 390 and control = 293) had fasting blood taken at baseline and month-6. RESULTS: At the end of the intervention, both the intervention and control groups had significantly increased BMI, however, when adjusted for gender and age, the BMI z-score in the intervention group showed no changes, whereas the control group had a significant increase in BMI z-score (mean difference of 0.03, 95% CI 0.04 to 0.06, p = 0.026). Fasting insulin showed significant reduction in the intervention group (-3.16 mcU/mL (95% CI -4.07 to -2.25), p < 0.001) versus control (-1.05 mcU/mL (95% CI -2.28 to 0.18), p = 0.095) (p < 0.001 between groups). A significantly greater reduction of HOMA-IR was observed in the intervention group (-0.41 (95% CI -0.63 to -0.19), p < 0.001) versus control (-0.17 (95% CI -0.45 to 0.11), p = 0.231)) (p < 0.001 between groups). HDL-C also showed significant increment of 0.34 mmol/L ((95% CI 0.32 to 0.36), p < 0.001) in the intervention and 0.11 mmol/L ((95% CI 0.08 to 0.14), p < 0.001) in the control group (p < 0.001 between groups). A significant reduction of TG: HDL-C ratio was observed in both the intervention (-0.17 mmol/L (95% CI -0.21 to -0.12), p < 0.001) and control groups (-0.12 mmol/L (95% CI -0.17 to -0.07), p < 0.001) (p = 0.524 between groups). CONCLUSION: MyBFFatschool resulted in significant improvements of fasting insulin, HOMA-IR and HDL-C in the intervention group. We recommend MyBFFatschool program to improve the cardiometabolic markers of the overweight and obese primary schoolchildren. TRIAL REGISTRATION: Clinical trial number: NCT04155255, November 7, 2019 (Retrospective registered).

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