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Clinical Trials/NCT03552367
NCT03552367
Unknown
N/A

Efficacy of a Structured Exercise Prescription Program Over Anthropometric, Metabolic and Fitness Parameters in Obese Children and Adolescents Included in a Multicomponent Lifestyle Intervention Program. Randomized Clinical Trial

Hospital General de México Dr. Eduardo Liceaga1 site in 1 country140 target enrollmentDecember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Hospital General de México Dr. Eduardo Liceaga
Enrollment
140
Locations
1
Primary Endpoint
VO2 max
Last Updated
7 years ago

Overview

Brief Summary

This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.

The parameters that will be evaluated between groups are physical fitness, anthropometry, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage, inflammatory biomarkers, anxiety and depression scores, and allelic variants related to physical fitness.

Detailed Description

This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity (study group) with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months. The parameters that will be evaluated between groups are physical fitness (measured by VO2max, ECG at rest, biomechanics and dynamometry), anthropometric measurements (weight height, BMI, plicometry, bioimpedance, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage (carotid intima-media thickness, atherogenic dyslipidemia), inflammatory biomarkers (leptin, adiponectin, IL-17, IL-10, INF-gamma, IL-6, IL-12, y TNF-alpha), anxiety and depression scores evaluated with Child Depression Inventory (CID) and -Trait Anxiety Inventory for Children (STAI-CH), and allelic variants related to physical fitness (ACTN, TRH2 y FTO).

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
July 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nayely Garibay Nieto

Head of the Child and Adolescent Obesity Clinic

Hospital General de México Dr. Eduardo Liceaga

Eligibility Criteria

Inclusion Criteria

  • Patients with BMI ≥ Pc 95 and \< 35kg/m2 Both sexes Accepts to participate and signs informed consent

Exclusion Criteria

  • Presence of endocrine disease including type I and II diabetes mellitus Presence of arterial hypertension Presence of primary dyslipidemia Presence of infections at moment of enrollment Presence of systemic disease Presence of genetic disorder Medical treatment that may interfere with lipid or glucose metabolism Prolonged or acute immobilization Participated in a previous similar intervention

Outcomes

Primary Outcomes

VO2 max

Time Frame: 6 months

Changes in VO2 max as fitness indicator

OGTT

Time Frame: 6 months

Oral glucose tolerance test

Secondary Outcomes

  • BMI(6 months)
  • AST(6 months)
  • ALT(6 months)
  • GGT(6 months)
  • Leptin(6 months)
  • Adiponectin(6 months)
  • Lean body mass(6 months)

Study Sites (1)

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