NCT01188642

Brief Summary

Obesity is now becoming significantly prevalent of an environment characterized by easily available calorics foods combined with sedentary lifestyles. Moreover, it has been demonstrated that obesity is associated with metabolic complications such as disturbed adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of this study is to assess the effects of a lifestyle intervention focused on various physical activities and nutrition education on adipocytokines hormones, in severely obese teenagers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

3 months

First QC Date

August 17, 2010

Last Update Submit

August 24, 2010

Conditions

HealthyObesity

Keywords

childhood obesityadipocytokinesphysical exercisenutrition education

Outcome Measures

Primary Outcomes (1)

  • Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples.

    during a lifestyle intervention of 9 months

Secondary Outcomes (5)

  • Body weight, body mass index, waist and hip circumference

    during a lifestyle intervention of 9 months

  • Body composition, calculated by a multifrequency bioelectric impedance

    during a lifestyle intervention of 9 months

  • Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis.

    during a lifestyle intervention of 9 months

  • Insulin resistance, calculated according to the formula of homeostasis model assessment

    during a lifestyle intervention of 9 months

  • Systolic and diastolic blood pressure, measured in millimeters of mercury at the level of the left brachial artery, using an automatic blood pressure monitor.

    during a lifestyle intervention of 9 months

Interventions

obesity lifestyle interventionBEHAVIORAL

physical activity 5 times per week + nutrition education

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

obese teenagers

You may qualify if:

  • to be aged from 12 to 17
  • to have a body mass index \> 97 percentile for age and gender

You may not qualify if:

  • systemic disease
  • endocrine disorder
  • syndromic obesity
  • subjects receiving medication with a history of recent intercurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Besançon, 25030, France

Location

Related Publications (2)

  • Gueugnon C, Mougin F, Simon-Rigaud ML, Regnard J, Negre V, Dumoulin G. Effects of an in-patient treatment program based on regular exercise and a balanced diet on high molecular weight adiponectin, resistin levels, and insulin resistance in adolescents with severe obesity. Appl Physiol Nutr Metab. 2012 Aug;37(4):672-9. doi: 10.1139/h2012-045. Epub 2012 May 11.

    PMID: 22574715DERIVED

  • Gueugnon C, Mougin F, Nguyen NU, Bouhaddi M, Nicolet-Guenat M, Dumoulin G. Ghrelin and PYY levels in adolescents with severe obesity: effects of weight loss induced by long-term exercise training and modified food habits. Eur J Appl Physiol. 2012 May;112(5):1797-805. doi: 10.1007/s00421-011-2154-2. Epub 2011 Sep 11.

    PMID: 21909986DERIVED

MeSH Terms

Conditions

ObesityPediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nhu Uyen Nguyen, MD, PhD

    Centre Hospitalier Universitaire de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 25, 2010

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Last Updated

August 25, 2010

Record last verified: 2010-08

Locations

FR(1)