Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Waist circumference
研究概览
简要总结
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.
详细描述
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:
- Effect on adiposity measured by BMI-zScore
- effect on gluco-insulin metabolism evaluated by homa-index
- effect on lipid profile evaluated by aterogenic index (AIP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity confirmed by BMI z-score >2 according to WHO growth charts
- •Age at recruitment ≥6 years
- •weight at birth ≥2500 g and <4000 g
- •gestational age 37-42 weeks
- •single birth
- •Caucasian ethny
- •family residing in Milan or neighborhood (≤30 km)
排除标准
- •Syndromic, organic and hormonal conditions besides obesity
- •Age at recruitment <6 years
- •Low birthweight (<2500 g), birthweight >4000 g
- •Pre-term or post-term birth
- •Twin delivery
- •Other ethnies than Caucasian
结局指标
主要结局
Waist circumference
时间窗: 0 (t0)-12 months (t1)
Expressed in cm
Height
时间窗: 0 (t0)-12 months (t1)
Expressed in meters
Tanner Stage
时间窗: 0 (t0)-12 months (t1)
Classification of sexual maturation according to Tanner criteria
Blood levels of LDL cholesterol
时间窗: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein A1 (ApoA1)
时间窗: 0 (t0)-12 months (t1)
Blood levels of glucose
时间窗: 0 (t0)-12 months (t1)
Triglyceride-Glucose index (TyG index)
时间窗: 0 (t0)-12 months (t1)
ln\[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2\]
Blood levels of total cholesterol
时间窗: 0 (t0)-12 months (t1)
Weight
时间窗: 0 (t0)-12 months (t1)
Expressed in Kilograms
Triceps Skinfold Thickness
时间窗: 0 (t0)-12 months (t1)
Expressed in mm, measured with an accurate plicometer
Body Mass Index (BMI)
时间窗: 0 (t0)-12 months (t1)
Expressed in kg/m\^2
Waist-to-height ratio
时间窗: 0 (t0)-12 months (t1)
The ratio between waist circumference (cm) and height (cm)
Blood levels of HDL cholesterol
时间窗: 0 (t0)-12 months (t1)
Blood levels of insulin
时间窗: 0 (t0)-12 months (t1)
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)
时间窗: 0 (t0)-12 months (t1)
calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5
Atherogenic Index of Plasma (AIP)
时间窗: 0 (t0)-12 months (t1)
log10 of the ratio of plasma triglycerides to HDL-cholesterol
Blood levels of triglycerides
时间窗: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein B (ApoB)
时间窗: 0 (t0)-12 months (t1)
QUantitative Insulin sensitivity ChecK (QUICK) index
时间窗: 0 (t0)-12 months (t1)
1/\[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)\]
HOMA-β%
时间窗: 0 (t0)-12 months (t1)
\[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5\]
次要结局
未报告次要终点
研究者
Elvira Verduci
MD PhD Assistant professor in Pediatrics
University of Milan
