Lifestyle Interventions and Metabolic Profile in Obese Children

NCT ID: NCT03728621

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-06-30

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:

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)

Conditions

Childhood Obesity; Obesity; Pediatric Obesity; Dyslipidemias; Cardiovascular Risk Factor; Life Style

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individual-based lifestyle intervention

Promotion of normocaloric \& balanced diet and physical activity

Group Type: EXPERIMENTAL

Normocaloric and balanced diet, physical activity

Intervention Type: BEHAVIORAL

Promotion of normocaloric \& balanced diet and physical activity

Group-based lifestyle intervention

Promotion of normocaloric \& balanced diet and physical activity

Group Type: EXPERIMENTAL

Normocaloric and balanced diet, physical activity

Intervention Type: BEHAVIORAL

Promotion of normocaloric \& balanced diet and physical activity

Interventions

Normocaloric and balanced diet, physical activity

Promotion of normocaloric \& balanced diet and physical activity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Elvira Verduci

MD PhD Assistant professor in Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Paolo

Milan, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33436021 (View on PubMed)

Other Identifiers

139/2010/CE

Identifier Type: -

Identifier Source: org_study_id