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NCT Number: NCT03728621

Lifestyle Interventions and Metabolic Profile in Obese Children

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.

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Key information

Conditions

Childhood Obesity Body Weight Cardiovascular Risk Factor Dyslipidemias Life Style Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Paolo

Milan, 20142, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normocaloric and balanced diet, physical activity

Behavioral

Promotion of normocaloric & balanced diet and physical activity

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Nov 2, 2018
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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