search
Back to results

Structured Exercise Prescription Program in Obese Children

Primary Purpose

Obesity, Exercise, Cardiovascular Risk Factor

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Personalized structured exercise program
Non personalized non-structured exercise program
Sponsored by
Hospital General de México Dr. Eduardo Liceaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Children, Non-alcoholic fatty acid liver disease, Exercise, Metabolic syndrome, Cardiovascular risk

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General de Mexico Eduardo LiceagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized structured exercise

Non-personalized non-structured exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

VO2 max
Changes in VO2 max as fitness indicator
OGTT
Oral glucose tolerance test

Secondary Outcome Measures

BMI
BMI zScore
AST
AST
ALT
ALT
GGT
GGT
Leptin
Leptin
Adiponectin
Adiponectin
Lean body mass
Lean body mass

Full Information

First Posted
April 24, 2018
Last Updated
June 8, 2018
Sponsor
Hospital General de México Dr. Eduardo Liceaga
Collaborators
National Council of Science and Technology, Mexico, Fundacion Sertull, Universidad Nacional Autonoma de Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT03552367
Brief Title
Structured Exercise Prescription Program in Obese Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de México Dr. Eduardo Liceaga
Collaborators
National Council of Science and Technology, Mexico, Fundacion Sertull, Universidad Nacional Autonoma de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Exercise, Cardiovascular Risk Factor, Liver Diseases, Metabolic Syndrome, Childhood Obesity
Keywords
Obesity, Children, Non-alcoholic fatty acid liver disease, Exercise, Metabolic syndrome, Cardiovascular risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized open clinical trial
Masking
None (Open Label)
Masking Description
This is an open-label trial
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized structured exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Non-personalized non-structured exercise
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Personalized structured exercise program
Other Intervention Name(s)
Structured exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non personalized non-structured exercise program
Other Intervention Name(s)
Non-structured exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
VO2 max
Description
Changes in VO2 max as fitness indicator
Time Frame
6 months
Title
OGTT
Description
Oral glucose tolerance test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
BMI
Description
BMI zScore
Time Frame
6 months
Title
AST
Description
AST
Time Frame
6 months
Title
ALT
Description
ALT
Time Frame
6 months
Title
GGT
Description
GGT
Time Frame
6 months
Title
Leptin
Description
Leptin
Time Frame
6 months
Title
Adiponectin
Description
Adiponectin
Time Frame
6 months
Title
Lean body mass
Description
Lean body mass
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nayely Garibay Nieto, MD MSc
Phone
+5255 2789 2000
Email
gngaribay@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayely Garibay Nieto, MD MSc
Organizational Affiliation
Director Child and Adolescent Obesity Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Mexico Eduardo Liceaga
City
Mexico City
State/Province
Del. Cuauhtemoc
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayely Garibay iIeto, MD MSc
Phone
2789 2000
Email
gngaribay@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not until first article is published
Citations:
PubMed Identifier
18055652
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. doi: 10.1542/peds.2007-2329D.
Results Reference
background
PubMed Identifier
16812927
Citation
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.
Results Reference
background
PubMed Identifier
27084289
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.
Results Reference
background
PubMed Identifier
27792271
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.
Results Reference
background
PubMed Identifier
22634075
Citation
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.
Results Reference
background

Learn more about this trial

Structured Exercise Prescription Program in Obese Children

We'll reach out to this number within 24 hrs