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Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers (OBAPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01188642
First Posted: August 25, 2010
Last Update Posted: August 25, 2010
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. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Besancon
  Purpose
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.

Condition Intervention
Healthy Obesity Behavioral: obesity lifestyle intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples. [ Time Frame: during a lifestyle intervention of 9 months ]

Secondary Outcome Measures:
  • Body weight, body mass index, waist and hip circumference [ Time Frame: during a lifestyle intervention of 9 months ]
  • Body composition, calculated by a multifrequency bioelectric impedance [ Time Frame: during a lifestyle intervention of 9 months ]
  • Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis. [ Time Frame: during a lifestyle intervention of 9 months ]
  • Insulin resistance, calculated according to the formula of homeostasis model assessment [ Time Frame: 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. [ Time Frame: during a lifestyle intervention of 9 months ]

Estimated Enrollment: 32
Study Start Date: March 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: obesity lifestyle intervention
    physical activity 5 times per week + nutrition education
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
obese teenagers
Criteria

Inclusion Criteria:

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

Exclusion criteria:

  • systemic disease
  • endocrine disorder
  • syndromic obesity
  • subjects receiving medication with a history of recent intercurrent illness
  Contacts and Locations
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): NCT01188642


Locations
France
Centre Hospitalier Universitaire
Besançon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Nhu Uyen Nguyen, MD, PhD Centre Hospitalier Universitaire de Besançon
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: P. Flammarion, Centre Hospitalier Universitaire de Besançon
ClinicalTrials.gov Identifier: NCT01188642     History of Changes
Other Study ID Numbers: P/2007/64
2007-A01319-44 ( Other Identifier: French Health Products Savety Agency )
First Submitted: August 17, 2010
First Posted: August 25, 2010
Last Update Posted: August 25, 2010
Last Verified: August 2010

Keywords provided by Centre Hospitalier Universitaire de Besancon:
childhood obesity
adipocytokines
physical exercise
nutrition education