This study evaluates if promotion of a normocaloric and balanced diet and of physical activity, through an individual- or group-based lifestyle intervention of 12 months, may affect anthropometric measurements and metabolic profile in obese children.
Obese children are at risk of metabolic and cardiovascular complications both during pediatric age and later and they often show components of metabolic syndrome, such as dyslipidemia, hypertension and disturbed glucose metabolism . These complications are strictly associated with insulin resistance/hyperinsulinemia which is one of the most important contributing factors to cardiovascular disease. The gold standard technique to determine whole-body insulin sensitivity, the hyperinsulinemic-euglycemic clamp, is expensive, invasive and requires considerable expertise to be performed. Therefore, several surrogate measures have been developed. Among these, the triglyceride-glucose index (TyG) is a useful indicator, providing an easily and widely available simple laboratory method as a surrogate to estimate insulin resistance in adult, children and adolescents. Other useful indicators of insulin resistance and insulin sensitivity are the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check (QUICK) index, respectively, while HOMA-β% is useful to evaluate pancreatic β-cell function. Among cardiovascular complications, obesity-related atherogenic dyslipidemia is a risk factor for cardiovascular disease. In childhood, atherogenic dyslipidemia may be associated with structural and functional vascular changes, as increased carotid intima-media thickness and increased arterial stiffness. The atherogenic index of plasma (AIP) is a recognized valuable indicator of the size of pre- and anti-atherogenic lipoprotein particle and is considered a major predictive marker of atherosclerosis risk. Additionally, it might be more promising than other lipid variables in assessing cardiovascular risk. Guidelines for treatment of childhood obesity recommend intensive lifestyle interventions, involving diet, physical activity and behavior change, in an age-appropriate manner. While it is recognized that these interventions could favorably influence some variables of metabolic profile of obese children, no study has reported accurate possible effect on triglyceride-glucose index and atherogenic index of plasma. Furthermore, pediatric obesity interventions may be group and/or individual-based. The group-based intervention requires less resources, children may benefit from a positive social environment, but the attention to individual needs is limited, which may weaken outcomes. On the other hand, the individual-based intervention allows to tailor dietary and physical counselling on individual's needs but is more expensive and requires greater resources. The aims of the study are to establish in patients who undergone individual versus group based intervention: 1. Effect on adiposity measured by BMI-zScore 2. effect on gluco-insulin metabolism evaluated by homa-index 3. effect on lipid profile evaluated by aterogenic index (AIP)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Promotion of normocaloric \& balanced diet and physical activity
Ospedale San Paolo
Milan, Italy
Height
Expressed in meters
Time frame: 0 (t0)-12 months (t1)
Blood levels of total cholesterol
Time frame: 0 (t0)-12 months (t1)
Weight
Expressed in Kilograms
Time frame: 0 (t0)-12 months (t1)
Body Mass Index (BMI)
Expressed in kg/m\^2
Time frame: 0 (t0)-12 months (t1)
Waist-to-height ratio
The ratio between waist circumference (cm) and height (cm)
Time frame: 0 (t0)-12 months (t1)
Waist circumference
Expressed in cm
Time frame: 0 (t0)-12 months (t1)
Triceps Skinfold Thickness
Expressed in mm, measured with an accurate plicometer
Time frame: 0 (t0)-12 months (t1)
Tanner Stage
Classification of sexual maturation according to Tanner criteria
Time frame: 0 (t0)-12 months (t1)
Blood levels of LDL cholesterol
Time frame: 0 (t0)-12 months (t1)
Blood levels of HDL cholesterol
Time frame: 0 (t0)-12 months (t1)
Blood levels of triglycerides
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Time frame: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein A1 (ApoA1)
Time frame: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein B (ApoB)
Time frame: 0 (t0)-12 months (t1)
Blood levels of insulin
Time frame: 0 (t0)-12 months (t1)
Blood levels of glucose
Time frame: 0 (t0)-12 months (t1)
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)
calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5
Time frame: 0 (t0)-12 months (t1)
QUantitative Insulin sensitivity ChecK (QUICK) index
1/\[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)\]
Time frame: 0 (t0)-12 months (t1)
HOMA-β%
\[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5\]
Time frame: 0 (t0)-12 months (t1)
Triglyceride-Glucose index (TyG index)
ln\[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2\]
Time frame: 0 (t0)-12 months (t1)
Atherogenic Index of Plasma (AIP)
log10 of the ratio of plasma triglycerides to HDL-cholesterol
Time frame: 0 (t0)-12 months (t1)