Lifestyle Interventions and Metabolic Profile in Obese Children
Primary Purpose
Childhood Obesity, Obesity, Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Normocaloric and balanced diet, physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring obesity, child, AIP, lifestyle intervention
Eligibility Criteria
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
Sites / Locations
- Ospedale San Paolo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Individual-based lifestyle intervention
Group-based lifestyle intervention
Arm Description
Promotion of normocaloric & balanced diet and physical activity
Promotion of normocaloric & balanced diet and physical activity
Outcomes
Primary Outcome Measures
Height
Expressed in meters
Blood levels of total cholesterol
Weight
Expressed in Kilograms
Body Mass Index (BMI)
Expressed in kg/m^2
Waist-to-height ratio
The ratio between waist circumference (cm) and height (cm)
Waist circumference
Expressed in cm
Triceps Skinfold Thickness
Expressed in mm, measured with an accurate plicometer
Tanner Stage
Classification of sexual maturation according to Tanner criteria
Blood levels of LDL cholesterol
Blood levels of HDL cholesterol
Blood levels of triglycerides
Blood levels of apolipoprotein A1 (ApoA1)
Blood levels of apolipoprotein B (ApoB)
Blood levels of insulin
Blood levels of glucose
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
QUantitative Insulin sensitivity ChecK (QUICK) index
1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]
HOMA-β%
[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]
Triglyceride-Glucose index (TyG index)
ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]
Atherogenic Index of Plasma (AIP)
log10 of the ratio of plasma triglycerides to HDL-cholesterol
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03728621
Brief Title
Lifestyle Interventions and Metabolic Profile in Obese Children
Official Title
Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Obesity, Pediatric Obesity, Dyslipidemias, Cardiovascular Risk Factor, Life Style
Keywords
obesity, child, AIP, lifestyle intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, prospective, controlled study of 12 months a total of 170 children were consecutively recruited among those with diagnosis of obesity (in accordance with World Health Organization (WHO) criteria) by primary care pediatricians and admitted to the Department of Pediatrics, San Paolo Hospital, Milan, Italy, between January 2012 and June 2017. Inclusion criteria were: age at recruitment ≥6 years; weight at birth ≥2500 g and <4000 g; gestational age 37-42 weeks; single birth; Caucasian race; family residing in Milan or neighborhood (≤30 km). Children having syndromic, organic and hormonal conditions besides obesity were excluded.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual-based lifestyle intervention
Arm Type
Experimental
Arm Description
Promotion of normocaloric & balanced diet and physical activity
Arm Title
Group-based lifestyle intervention
Arm Type
Experimental
Arm Description
Promotion of normocaloric & balanced diet and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Normocaloric and balanced diet, physical activity
Intervention Description
Promotion of normocaloric & balanced diet and physical activity
Primary Outcome Measure Information:
Title
Height
Description
Expressed in meters
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of total cholesterol
Time Frame
0 (t0)-12 months (t1)
Title
Weight
Description
Expressed in Kilograms
Time Frame
0 (t0)-12 months (t1)
Title
Body Mass Index (BMI)
Description
Expressed in kg/m^2
Time Frame
0 (t0)-12 months (t1)
Title
Waist-to-height ratio
Description
The ratio between waist circumference (cm) and height (cm)
Time Frame
0 (t0)-12 months (t1)
Title
Waist circumference
Description
Expressed in cm
Time Frame
0 (t0)-12 months (t1)
Title
Triceps Skinfold Thickness
Description
Expressed in mm, measured with an accurate plicometer
Time Frame
0 (t0)-12 months (t1)
Title
Tanner Stage
Description
Classification of sexual maturation according to Tanner criteria
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of LDL cholesterol
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of HDL cholesterol
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of triglycerides
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of apolipoprotein A1 (ApoA1)
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of apolipoprotein B (ApoB)
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of insulin
Time Frame
0 (t0)-12 months (t1)
Title
Blood levels of glucose
Time Frame
0 (t0)-12 months (t1)
Title
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Description
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)
Title
QUantitative Insulin sensitivity ChecK (QUICK) index
Description
1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]
Time Frame
0 (t0)-12 months (t1)
Title
HOMA-β%
Description
[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]
Time Frame
0 (t0)-12 months (t1)
Title
Triglyceride-Glucose index (TyG index)
Description
ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]
Time Frame
0 (t0)-12 months (t1)
Title
Atherogenic Index of Plasma (AIP)
Description
log10 of the ratio of plasma triglycerides to HDL-cholesterol
Time Frame
0 (t0)-12 months (t1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ospedale San Paolo
City
Milan
ZIP/Postal Code
20142
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33436021
Citation
Verduci E, Banderali G, Di Profio E, Vizzuso S, Zuccotti G, Radaelli G. Effect of individual- versus collective-based nutritional-lifestyle intervention on the atherogenic index of plasma in children with obesity: a randomized trial. Nutr Metab (Lond). 2021 Jan 13;18(1):11. doi: 10.1186/s12986-020-00537-w.
Results Reference
derived
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Lifestyle Interventions and Metabolic Profile in Obese Children
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