Obesity Clinical Trial
Official title:
Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
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)
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