NCT03552367

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

June 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

April 24, 2018

Last Update Submit

June 8, 2018

Conditions

ObesityExerciseCardiovascular Risk FactorLiver DiseasesMetabolic SyndromeChildhood Obesity

Keywords

ObesityChildrenNon-alcoholic fatty acid liver diseaseExerciseMetabolic syndromeCardiovascular risk

Outcome Measures

Primary Outcomes (2)

  • VO2 max

    Changes in VO2 max as fitness indicator

    6 months

  • OGTT

    Oral glucose tolerance test

    6 months

Secondary Outcomes (7)

  • BMI

    6 months

  • AST

    6 months

  • ALT

    6 months

  • GGT

    6 months

  • Leptin

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Personalized structured exercise

EXPERIMENTAL

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

Non-personalized non-structured exercise

ACTIVE COMPARATOR

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

Interventions

Personalized structured exercise programOTHER

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

Also known as: Structured exercise
Personalized structured exercise
Non personalized non-structured exercise programOTHER

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

Also known as: Non-structured exercise
Non-personalized non-structured exercise

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Mexico Eduardo Liceaga

Mexico City, Del. Cuauhtemoc, 06720, Mexico

RECRUITING

Related Publications (5)

  • 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.

    PMID: 18055652BACKGROUND

  • 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.

    PMID: 16812927BACKGROUND

  • 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.

    PMID: 27084289BACKGROUND

  • 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.

    PMID: 27792271BACKGROUND

  • 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.

    PMID: 22634075BACKGROUND

MeSH Terms

Conditions

ObesityMotor ActivityLiver DiseasesMetabolic SyndromePediatric Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Nayely Garibay Nieto, MD MSc

    Director Child and Adolescent Obesity Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayely Garibay Nieto, MD MSc

CONTACT

+5255 2789 2000gngaribay@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized open clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Child and Adolescent Obesity Clinic

Study Record Dates

First Submitted

April 24, 2018

First Posted

June 11, 2018

Study Start

December 1, 2017

Primary Completion

December 31, 2019

Study Completion

July 31, 2020

Last Updated

June 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Not until first article is published

Locations

ME(1)