Obesity Clinical Trial
Official title:
Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
NCT number | NCT03728621 |
Other study ID # | 139/2010/CE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | June 2018 |
Verified date | October 2018 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | June 2018 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Paolo | Milan |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Height | Expressed in meters | 0 (t0)-12 months (t1) | |
Primary | Blood levels of total cholesterol | 0 (t0)-12 months (t1) | ||
Primary | Weight | Expressed in Kilograms | 0 (t0)-12 months (t1) | |
Primary | Body Mass Index (BMI) | Expressed in kg/m^2 | 0 (t0)-12 months (t1) | |
Primary | Waist-to-height ratio | The ratio between waist circumference (cm) and height (cm) | 0 (t0)-12 months (t1) | |
Primary | Waist circumference | Expressed in cm | 0 (t0)-12 months (t1) | |
Primary | Triceps Skinfold Thickness | Expressed in mm, measured with an accurate plicometer | 0 (t0)-12 months (t1) | |
Primary | Tanner Stage | Classification of sexual maturation according to Tanner criteria | 0 (t0)-12 months (t1) | |
Primary | Blood levels of LDL cholesterol | 0 (t0)-12 months (t1) | ||
Primary | Blood levels of HDL cholesterol | 0 (t0)-12 months (t1) | ||
Primary | Blood levels of triglycerides | 0 (t0)-12 months (t1) | ||
Primary | Blood levels of apolipoprotein A1 (ApoA1) | 0 (t0)-12 months (t1) | ||
Primary | Blood levels of apolipoprotein B (ApoB) | 0 (t0)-12 months (t1) | ||
Primary | Blood levels of insulin | 0 (t0)-12 months (t1) | ||
Primary | Blood levels of glucose | 0 (t0)-12 months (t1) | ||
Primary | 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 | 0 (t0)-12 months (t1) | |
Primary | QUantitative Insulin sensitivity ChecK (QUICK) index | 1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)] | 0 (t0)-12 months (t1) | |
Primary | HOMA-ß% | [20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5] | 0 (t0)-12 months (t1) | |
Primary | Triglyceride-Glucose index (TyG index) | ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2] | 0 (t0)-12 months (t1) | |
Primary | Atherogenic Index of Plasma (AIP) | log10 of the ratio of plasma triglycerides to HDL-cholesterol | 0 (t0)-12 months (t1) |
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