Cardiometabolic outcome of MyBFF@school intervention program among secondary schoolchildren: a cluster randomized controlled trial

BACKGROUND: Type 2 diabetes, hypertension, and dyslipidemia are comorbidities associated with obesity in children and adolescents. This school-based, cluster-randomized controlled study evaluated the effectiveness of a 6-month intervention (MyBFF@school) on cardiometabolic markers among overweight and obese Malaysian adolescents. METHODS: This study involved proportionate stratified random sampling of government schools in three selected states in Malaysia. Fifteen out of 416 schools were selected. Schoolchildren aged 13–16 years with body mass index (BMI) z-score greater than + 1 SD (WHO) were recruited. The outcome measures included fasting plasma glucose, fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), lipid profiles, TG:HDL-C ratio and blood pressure.. Repeated measures ANOVA and ANCOVA were used to assess within- and between-group effects. RESULTS: From 1041 adolescents, 552 (intervention = 306 and control = 246) had complete fasting bloods taken at baseline and month˗6. BMI z-scores decreased significantly within both groups, but no between-group differences were observed. Notably, BMI increased (albeit small) within the intervention group compared with baseline (mean difference (MD) 0.17 kg/m2; 95% confident interval (CI) 0.02, 0.32). A greater increase of HDL-C was observed in the intervention group at month-6 (MD = 0.06 mmol/L, 95% CI0.10,0.20). Fasting insulin was significantly decreased within the intervention group (MD = − 2.24 μU/mL (95% CI − 3.37, − 1.17) but no significant changes were detected between groups. Unexpectedly, fasting plasma glucose showed significant increase in both groups post-intervention (MD = 0.38, 95%CI 0.28,0.48). Similarly, although within normal range, significant increase of total cholesterol, TG and LDL-C, (MD = 0.36, 95%CI 0.25,0.47, MD = 0.26 95%CI 0.17,0.35 and MD = 0.30 95%CI 0.18,0.42 respectively) was observed. Additionally, significant increase of systolic and diastolic blood pressure was observed in the intervention group post- intervention compared to control group (MD = 3.68 95%CI 2.01,5.35 and MD = 4.29 95%CI 2.85,5.73) respectively. CONCLUSION: The MyBFF@school programme, resulted in reductions in BMI z-score in both groups; however, increases in BMI and several cardiometabolic markers were also observed within the intervention group. These mixed findings underscore the importance of evaluating both anthropometric and metabolic outcomes when assessing the effectiveness and safety of obesity interventions in adolescents. TRIAL REGISTRATION: Clinical trial number: NCT04155255, November 7, 2019 (Retrospective registered). National Medical Research Register: NMRR-13–439-16563. Registered July 23, 2013. The intervention program was approved by the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia and Educational Planning and Research Division (EPRD), Ministry of Education Malaysia. It was funded by the Ministry of Health Malaysia.