Structured Exercise Prescription Program in Obese Children

Not Applicable

• Conditions: Childhood Obesity; Liver Diseases; Exercise; Cardiovascular Risk Factor; Metabolic Syndrome; Obesity
• Interventions: Other: Personalized structured exercise program; Other: Non personalized non-structured exercise program

• Registration Number: NCT03552367
• Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga

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).

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-04-24
• Status Verified: 2018-05
• Study First Submitted QC: 2018-06-08
• Last Update Submitted: 2018-06-08
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized structured exercise	Personalized structured exercise program	This group will be enrolled in a multicomponent program for obese children (8-12 years old) that includes intervention workshops concerning nutrition, emotional factors, cognitive therapy and personalized structured exercise prescription that will be offered on-site and online and monitored through the use of heart rate monitoring devices. The type of exercise offered to patients in this arm is precisely designed for obese patients according to age and physical fitness parameters. Intervention: Non-personalized non-structured exercise
Non-personalized non-structured exercise	Non personalized non-structured exercise program	This group will be enrolled in a multicomponent program for obese children (8-12 years old) that includes intervention workshops concerning nutrition, emotional factors, cognitive therapy and non-personalized non-structured exercise prescription Intervention: Non-personalized non-structured exercise

Primary Outcome Measures

Name	Time	Method
VO2 max	6 months	Changes in VO2 max as fitness indicator
OGTT	6 months	Oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
BMI	6 months	BMI zScore
AST	6 months	AST
ALT	6 months	ALT
GGT	6 months	GGT
Leptin	6 months	Leptin
Adiponectin	6 months	Adiponectin
Lean body mass	6 months	Lean body mass

Trial Locations

Locations (1)

Hospital General de Mexico Eduardo Liceaga; 🇲🇽 Mexico City, Del. Cuauhtemoc, Mexico