Cardiovascular Risk Factor, Childhood Obesity, Exercise, Liver Diseases, Metabolic Syndrome, Obesity
Conditions
Keywords
Obesity, Children, Non-alcoholic fatty acid liver disease, Exercise, Metabolic syndrome, Cardiovascular risk
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).
Interventions
OTHERPersonalized structured exercise program
The type of exercise offered to patients in this arm is precisely designed for obese patients according to age and physical fitness parameters. Patients are monitored using a heart rate monitor to evaluate treatment adherence and compliance
OTHERNon personalized non-structured exercise program
The type of exercise is non-structured and patients' heart rate is not monitored. Patients receive exercise recommendations without any personalization according to their fitness parameters
Sponsors
National Council of Science and Technology, Mexico
Fundacion Sertull
Universidad Nacional Autonoma de Mexico
Hospital General de México Dr. Eduardo Liceaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial
Intervention model description
Randomized open clinical trial
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 max | 6 months | Changes in VO2 max as fitness indicator |
| OGTT | 6 months | Oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AST | 6 months | AST |
| ALT | 6 months | ALT |
| GGT | 6 months | GGT |
| Adiponectin | 6 months | Adiponectin |
| Lean body mass | 6 months | Lean body mass |
| Leptin | 6 months | Leptin |
| BMI | 6 months | BMI zScore |
Countries
Mexico
Contacts
Primary ContactNayely Garibay Nieto, MD MSc
Outcome results
None listed