Structured Exercise Prescription Program in Obese Children
- Conditions
- Childhood ObesityLiver DiseasesExerciseCardiovascular Risk FactorMetabolic SyndromeObesity
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
Patients with BMI ≥ Pc 95 and < 35kg/m2 Both sexes Accepts to participate and signs informed consent
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
- 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
Hospital General de Mexico Eduardo Liceaga🇲🇽Mexico City, Del. Cuauhtemoc, MexicoNayely Garibay iIeto, MD MScContact2789 2000gngaribay@hotmail.com