Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Structured Exercise Prescription Program in Obese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03552367
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Fundacion Sertull
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Nayely Garibay Nieto, Hospital General de México Dr. Eduardo Liceaga

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Exercise Cardiovascular Risk Factor Liver Diseases Metabolic Syndrome Childhood Obesity Other: Personalized structured exercise program Other: Non personalized non-structured exercise program Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open clinical trial
Masking: None (Open Label)
Masking Description: This is an open-label trial
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Non-structured exercise




Primary Outcome Measures :
  1. VO2 max [ Time Frame: 6 months ]
    Changes in VO2 max as fitness indicator

  2. OGTT [ Time Frame: 6 months ]
    Oral glucose tolerance test


Secondary Outcome Measures :
  1. BMI [ Time Frame: 6 months ]
    BMI zScore

  2. AST [ Time Frame: 6 months ]
    AST

  3. ALT [ Time Frame: 6 months ]
    ALT

  4. GGT [ Time Frame: 6 months ]
    GGT

  5. Leptin [ Time Frame: 6 months ]
    Leptin

  6. Adiponectin [ Time Frame: 6 months ]
    Adiponectin

  7. Lean body mass [ Time Frame: 6 months ]
    Lean body mass



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552367


Contacts
Layout table for location contacts
Contact: Nayely Garibay Nieto, MD MSc +5255 2789 2000 gngaribay@hotmail.com

Locations
Layout table for location information
Mexico
Hospital General de Mexico Eduardo Liceaga Recruiting
Mexico City, Del. Cuauhtemoc, Mexico, 06720
Contact: Nayely Garibay iIeto, MD MSc    2789 2000    gngaribay@hotmail.com   
Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
National Council of Science and Technology, Mexico
Fundacion Sertull
Universidad Nacional Autonoma de Mexico
Investigators
Layout table for investigator information
Principal Investigator: Nayely Garibay Nieto, MD MSc Director Child and Adolescent Obesity Clinic

Publications:
Layout table for additonal information
Responsible Party: Nayely Garibay Nieto, Head of the Child and Adolescent Obesity Clinic, Hospital General de México Dr. Eduardo Liceaga
ClinicalTrials.gov Identifier: NCT03552367     History of Changes
Other Study ID Numbers: DI/17/311/03/028
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not until first article is published

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nayely Garibay Nieto, Hospital General de México Dr. Eduardo Liceaga:
Obesity
Children
Non-alcoholic fatty acid liver disease
Exercise
Metabolic syndrome
Cardiovascular risk

Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Body Weight
Obesity
Liver Diseases
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases