Title: Obesity and Overweight in Children and AdolescentsDescription:Children and adolescents aged 12–18 years with a body mass index (BMI) above the 95th percentile for age and sex or between the 85th and 95th percentiles with at least one comorbidity (based on WHO and CDC criteria). Obesity due to excess calories
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Children aged 12 to 18 years (based on similar studies (19) and the homogeneity of studies, this age group was selected, and according to the definition of the World Health Organization, the age group of 10 to 19 years is considered adolescence) • Body mass index (BMI) above the 95th percentile for age and sex according to the World Health Organization criteria or between the 85th and 95th percentiles with at least one comorbidity including:- Prediabetes: impaired fasting glucose 5.6 to 6.9 mmol/L and/or impaired glucose tolerance: glucose 2 hours after eating 7.8 to 11.1 mmol/L- Insulin resistance (defined as a fasting insulin (pmol/L)/glucose (mmol/L) ratio > 20- Presence of acanthosis nigricans- High blood pressure (defined as systolic and/or diastolic blood pressure above the 90th percentile for sex, age, and height)- Low HDL cholesterol (defined as <1.03 mmol/L)- High triglycerides (defined as =1.7 mmol/L)- High alanine transaminase (ALT) or gamma-glutamyl transferase (GGT) (defined as ALT or GGT <45 U/L)- Diagnosis of polycystic ovary syndrome Willingness to participate and adherence to the study protocol Written informed consent from parents and verbal assent from children
Exclusion criteria
Exclusion criteria: Obesity due to secondary causes (such as endocrine diseases) Taking medications that affect weight (except metformin if necessary) Participating in other weight loss programs Inability to adhere to the diet Body mass index greater than 140% of the 99th percentile (These children will not be eligible to participate in the study due to the higher risk of developing comorbidities that require additional multidisciplinary specialist care during the trial period)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index. Timepoint: Before intervention and weeks 4, 8, and 12. Method of measurement: Standard scales and height gauges. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition. Timepoint: Before intervention and week 12. Method of measurement: tanita BC418.;Biochemical factors include: lipid profile, liver enzymes, glycosylated hemoglobin, insulin, fasting blood sugar. Timepoint: Before intervention and week 12. Method of measurement: Blood test.;Anthropometrics including: waist circumference, hip circumference, and neck circumference. Timepoint: Before intervention and week 12. Method of measurement: Standard tape measure.;Quality of life score. Timepoint: Before intervention and week 12. Method of measurement: Pediatric Quality of Life Questionnaire.;Eating behavior. Timepoint: Before intervention and week 12. Method of measurement: Children’s Eating Behavior Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Mashhad University of Medical Sciences