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Lifestyle Interventions and Metabolic Profile in Obese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03728621
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
Elvira Verduci, University of Milan

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Obesity Pediatric Obesity Dyslipidemias Cardiovascular Risk Factor Life Style Behavioral: Normocaloric and balanced diet, physical activity Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
Actual Study Start Date : January 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2018

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

Primary Outcome Measures :
  1. Height [ Time Frame: 0 (t0)-12 months (t1) ]
    Expressed in meters

  2. Blood levels of total cholesterol [ Time Frame: 0 (t0)-12 months (t1) ]
  3. Weight [ Time Frame: 0 (t0)-12 months (t1) ]
    Expressed in Kilograms

  4. Body Mass Index (BMI) [ Time Frame: 0 (t0)-12 months (t1) ]
    Expressed in kg/m^2

  5. Waist-to-height ratio [ Time Frame: 0 (t0)-12 months (t1) ]
    The ratio between waist circumference (cm) and height (cm)

  6. Waist circumference [ Time Frame: 0 (t0)-12 months (t1) ]
    Expressed in cm

  7. Triceps Skinfold Thickness [ Time Frame: 0 (t0)-12 months (t1) ]
    Expressed in mm, measured with an accurate plicometer

  8. Tanner Stage [ Time Frame: 0 (t0)-12 months (t1) ]
    Classification of sexual maturation according to Tanner criteria

  9. Blood levels of LDL cholesterol [ Time Frame: 0 (t0)-12 months (t1) ]
  10. Blood levels of HDL cholesterol [ Time Frame: 0 (t0)-12 months (t1) ]
  11. Blood levels of triglycerides [ Time Frame: 0 (t0)-12 months (t1) ]
  12. Blood levels of apolipoprotein A1 (ApoA1) [ Time Frame: 0 (t0)-12 months (t1) ]
  13. Blood levels of apolipoprotein B (ApoB) [ Time Frame: 0 (t0)-12 months (t1) ]
  14. Blood levels of insulin [ Time Frame: 0 (t0)-12 months (t1) ]
  15. Blood levels of glucose [ Time Frame: 0 (t0)-12 months (t1) ]
  16. HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 0 (t0)-12 months (t1) ]
    calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5

  17. QUantitative Insulin sensitivity ChecK (QUICK) index [ Time Frame: 0 (t0)-12 months (t1) ]
    1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]

  18. HOMA-β% [ Time Frame: 0 (t0)-12 months (t1) ]
    [20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]

  19. Triglyceride-Glucose index (TyG index) [ Time Frame: 0 (t0)-12 months (t1) ]
    ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]

  20. Atherogenic Index of Plasma (AIP) [ Time Frame: 0 (t0)-12 months (t1) ]
    log10 of the ratio of plasma triglycerides to HDL-cholesterol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03728621

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Ospedale San Paolo
Milan, Italy, 20142
Sponsors and Collaborators
University of Milan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Elvira Verduci, MD PhD Assistant professor in Pediatrics, University of Milan Identifier: NCT03728621    
Other Study ID Numbers: 139/2010/CE
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elvira Verduci, University of Milan:
lifestyle intervention
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight
Lipid Metabolism Disorders
Metabolic Diseases