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

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01188642
First received: August 17, 2010
Last updated: August 24, 2010
Last verified: August 2010
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight, body mass index, waist and hip circumference [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • Body composition, calculated by a multifrequency bioelectric impedance [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis. [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • Insulin resistance, calculated according to the formula of homeostasis model assessment [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Centre Hospitalier Universitaire de Besancon

Additional 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
Study First Received: August 17, 2010
Last Updated: August 24, 2010
Health Authority: France:AFSSAPS, French Health Products Savety Agency

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014