Structured Exercise Prescription Program in Obese Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Diseases; Obesity; Metabolic Syndrome; Exercise; Childhood Obesity; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Personalized structured exercise program; Other: Non personalized non-structured exercise program

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).

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nayely Garibay Nieto, MD MSc; Phone Number: +5255 2789 2000; Email: gngaribay@hotmail.com

Study Locations

• Mexico
  • Del. Cuauhtemoc
    • Mexico City, Del. Cuauhtemoc, Mexico, 06720
      • Recruiting
      • Hospital General de Mexico Eduardo Liceaga
      • Contact: Nayely Garibay iIeto, MD MSc; Phone Number: 2789 2000; Email: gngaribay@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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 Names: 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	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; Other Names: Non-structured exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	Changes in VO2 max as fitness indicator	6 months
OGTT	Oral glucose tolerance test	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	BMI zScore	6 months
AST	AST	6 months
ALT	ALT	6 months
GGT	GGT	6 months
Leptin	Leptin	6 months
Adiponectin	Adiponectin	6 months
Lean body mass	Lean body mass	6 months

Collaborators and Investigators

• Sponsor: Hospital General de México Dr. Eduardo Liceaga
• Collaborators: National Council of Science and Technology, Mexico; Universidad Nacional Autonoma de Mexico; Fundacion Sertull
• Investigators: Principal Investigator: Nayely Garibay Nieto, MD MSc, Director Child and Adolescent Obesity Clinic

Publications and helpful links

General Publications

• 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. doi: 10.1542/peds.2007-2329D.
• 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. doi: 10.1016/j.jada.2006.03.001.
• 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.
• Lison JF, Real-Montes JM, Torro I, Arguisuelas MD, Alvarez-Pitti J, Martinez-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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Metabolic syndrome; Children; Cardiovascular risk; Non-alcoholic fatty acid liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Liver Diseases; Obesity; Metabolic Syndrome; Pediatric Obesity
• Other Study ID Numbers: DI/17/311/03/028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not until first article is published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No