Structured Exercise Prescription Program in Obese Children

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2019

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

  • 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
  • Other: 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

Arms, Groups and Cohorts

  • Experimental: Personalized structured exercise
    • 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
  • Active Comparator: Non-personalized non-structured exercise
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • VO2 max
    • Time Frame: 6 months
    • Changes in VO2 max as fitness indicator
  • OGTT
    • Time Frame: 6 months
    • Oral glucose tolerance test

Secondary Measures

  • BMI
    • Time Frame: 6 months
    • BMI zScore
  • AST
    • Time Frame: 6 months
    • AST
  • ALT
    • Time Frame: 6 months
    • ALT
  • GGT
    • Time Frame: 6 months
    • GGT
  • Leptin
    • Time Frame: 6 months
    • Leptin
  • Adiponectin
    • Time Frame: 6 months
    • Adiponectin
  • Lean body mass
    • Time Frame: 6 months
    • Lean body mass

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General de México Dr. Eduardo Liceaga
  • Collaborator
    • National Council of Science and Technology, Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nayely Garibay Nieto, Head of the Child and Adolescent Obesity Clinic – Hospital General de México Dr. Eduardo Liceaga
  • Overall Official(s)
    • Nayely Garibay Nieto, MD MSc, Principal Investigator, Director Child and Adolescent Obesity Clinic
  • Overall Contact(s)
    • Nayely Garibay Nieto, MD MSc, +5255 2789 2000, gngaribay@hotmail.com

References

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.

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.

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.

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.

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.

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