Structured Exercise Prescription Program in Obese Children

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552367
• Other study ID #: DI/17/311/03/028
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Childhood Obesity
• Exercise
• Liver Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Pediatric Obesity

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