Lifestyle Interventions and Metabolic Profile in Obese Children

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dyslipidemias; Pediatric Obesity; Childhood Obesity; Cardiovascular Risk Factor; Life Style
• Intervention / Treatment: Behavioral: Normocaloric and balanced diet, physical activity

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:

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
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20142
    • Ospedale San Paolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual-based lifestyle intervention; Promotion of normocaloric & balanced diet and physical activity	Behavioral: Normocaloric and balanced diet, physical activity; Promotion of normocaloric & balanced diet and physical activity
Experimental: Group-based lifestyle intervention; Promotion of normocaloric & balanced diet and physical activity	Behavioral: Normocaloric and balanced diet, physical activity; Promotion of normocaloric & balanced diet and physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Expressed in meters	0 (t0)-12 months (t1)
Blood levels of total cholesterol		0 (t0)-12 months (t1)
Weight	Expressed in Kilograms	0 (t0)-12 months (t1)
Body Mass Index (BMI)	Expressed in kg/m^2	0 (t0)-12 months (t1)
Waist-to-height ratio	The ratio between waist circumference (cm) and height (cm)	0 (t0)-12 months (t1)
Waist circumference	Expressed in cm	0 (t0)-12 months (t1)
Triceps Skinfold Thickness	Expressed in mm, measured with an accurate plicometer	0 (t0)-12 months (t1)
Tanner Stage	Classification of sexual maturation according to Tanner criteria	0 (t0)-12 months (t1)
Blood levels of LDL cholesterol		0 (t0)-12 months (t1)
Blood levels of HDL cholesterol		0 (t0)-12 months (t1)
Blood levels of triglycerides		0 (t0)-12 months (t1)
Blood levels of apolipoprotein A1 (ApoA1)		0 (t0)-12 months (t1)
Blood levels of apolipoprotein B (ApoB)		0 (t0)-12 months (t1)
Blood levels of insulin		0 (t0)-12 months (t1)
Blood levels of glucose		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	0 (t0)-12 months (t1)
QUantitative Insulin sensitivity ChecK (QUICK) index	1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]	0 (t0)-12 months (t1)
HOMA-β%	[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]	0 (t0)-12 months (t1)
Triglyceride-Glucose index (TyG index)	ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]	0 (t0)-12 months (t1)
Atherogenic Index of Plasma (AIP)	log10 of the ratio of plasma triglycerides to HDL-cholesterol	0 (t0)-12 months (t1)

Collaborators and Investigators

• Sponsor: University of Milan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: obesity; child; lifestyle intervention; AIP
• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lipid Metabolism Disorders; Obesity; Pediatric Obesity; Dyslipidemias
• Other Study ID Numbers: 139/2010/CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No