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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03552367
Other study ID # DI/17/311/03/028
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date July 31, 2020

Study information

Verified date May 2018
Source Hospital General de México Dr. Eduardo Liceaga
Contact Nayely Garibay Nieto, MD MSc
Phone +5255 2789 2000
Email gngaribay@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 8 Years to 16 Years
Eligibility 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


Intervention

Other:
Personalized 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
Non 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

Locations

Country Name City State
Mexico Hospital General de Mexico Eduardo Liceaga Mexico City Del. Cuauhtemoc

Sponsors (4)

Lead Sponsor Collaborator
Hospital General de México Dr. Eduardo Liceaga Fundacion Sertull, National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

American Dietetic Association (ADA). Position of the American Dietetic Association: individual-, family-, school-, and community-based interventions for pediatric overweight. J Am Diet Assoc. 2006 Jun;106(6):925-45. — View Citation

Kelley GA, Kelley KS, Pate RR. Exercise and BMI z-score in Overweight and Obese Children and Adolescents: A Systematic Review and Network Meta-Analysis of Randomized Trials. J Evid Based Med. 2017 May;10(2):108-128. doi: 10.1111/jebm.12228. Review. — View Citation

Kelley GA, Kelley KS. Exercise and BMI z-score in overweight and obese children and adolescents: protocol for a systematic review and network meta-analysis of randomised trials. BMJ Open. 2016 Apr 15;6(4):e011258. doi: 10.1136/bmjopen-2016-011258. Review. — View Citation

Krebs NF, Himes JH, Jacobson D, Nicklas TA, Guilday P, Styne D. Assessment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S193-228. Review. — View Citation

Lisón JF, Real-Montes JM, Torró I, Arguisuelas MD, Alvarez-Pitti J, Martínez-Gramage J, Aguilar F, Lurbe E. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups. Acad Pediatr. 2012 Jul-Aug;12(4):319-25. doi: 10.1016/j.acap.2012.03.003. Epub 2012 May 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VO2 max Changes in VO2 max as fitness indicator 6 months
Primary OGTT Oral glucose tolerance test 6 months
Secondary BMI BMI zScore 6 months
Secondary AST AST 6 months
Secondary ALT ALT 6 months
Secondary GGT GGT 6 months
Secondary Leptin Leptin 6 months
Secondary Adiponectin Adiponectin 6 months
Secondary Lean body mass Lean body mass 6 months
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