Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection (DIVINE)
Health Behavior, Child Development, Adolescent Obesity
About this trial
This is an interventional prevention trial for Health Behavior focused on measuring adolescent, probiotics, COVID-19, overweight, obese
Eligibility Criteria
Inclusion Criteria: living in Jakarta, Surabaya, and Yogyakarta City for at least 6 months permanently; apparently healthy; male and female, age 12-17 years old; overweight or obese (BMI-for-age z-score >+1SD); have completed at least two dosages of COVID-19 vaccine, the vaccine must be CoronaVac® (Sinovac); minimal 6 months post vaccinated prior to recruitments. parents willing to sign the informed consent and adolescents give informed assent; Must have an active health insurance, for instance BPJS or similar health insurance. Exclusion Criteria: having a history of COVID-19 infection within the last month confirmed by PCR or antigen from health care facilities or independent laboratory; having a history of chronic and non-communicable diseases, congenital diseases, and disabilities; reported current diagnosed as suspected active Tuberculosis (primary lung TB, miliary TB, bleeding cough bone TB, meningitis TB); having a history of gastrointestinal or malabsorption disorder (such as celiac disease and inflammatory bowel disease) within the last three months or during the study; taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake); taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood transfusion or other blood products; taking insulin and/or anti-dyslipidemia medication; being pregnant and/or breastfeeding.
Sites / Locations
- Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas IndonesiaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention
Control
220 overweight/obese adolescents will be given Probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.
220 overweight/obese adolescents will be given placebo probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.