Structured Exercise Prescription Program in Obese Children
NCT ID: NCT03552367
Last Updated: 2018-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2017-12-01
2020-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
8 Years
16 Years
ALL
No
Sponsors
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National Council of Science and Technology, Mexico
OTHER
Fundacion Sertull
UNKNOWN
Universidad Nacional Autonoma de Mexico
OTHER
Hospital General de México Dr. Eduardo Liceaga
OTHER_GOV
Responsible Party
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Nayely Garibay Nieto
Head of the Child and Adolescent Obesity Clinic
Principal Investigators
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Nayely Garibay Nieto, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Director Child and Adolescent Obesity Clinic
Locations
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Hospital General de Mexico Eduardo Liceaga
Mexico City, Del. Cuauhtemoc, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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DI/17/311/03/028
Identifier Type: -
Identifier Source: org_study_id
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