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Multidisciplinary Ambulatory Intervention Program in Family of Children and Adolescents With Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344747
First Posted: June 27, 2006
Last Update Posted: September 21, 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:
Soroka University Medical Center
  Purpose

Obesity has become a pandemic, and it is today's principal neglected public health problem.

Obesity has increased dramatically during the past two decades At adolescence, it is an aggravating issue, because obesity tends to persist in adulthood and the longer its duration, the higher the associated mortality and morbidity. Obesity imposes a heavy health and social burden, and it is widely recognized that treatment is costly. If obesity is not successfully addressed by late adolescence, the likelihood of weight loss in adulthood is as low as 5%. Therefore, prevention is crucial, and children and adolescents should be a priority target.

Treatment of obesity is costly, time consuming, difficult and the results aren't always satisfying On most cases the patients receive dietary advice only (6-10 visits per year). And usually the patients end the treatment early due to lack of results.

The best treatment of children and adolescent obesity is done in highly specialized settings, by a multidisciplinary team. Those programs have a limited number of locations (not always in proximity to the patients' residence), in addition, they are long term treatments and therefore are hard to complete successfully without additional support, Therefore only a limited number of patients can benefit from such programs.

Due to the reasons mentioned above, many families tend not to start the process of treating their obese child, or turn to commercial weight loss programs, or put their children according to their beliefs and diets.

Therefore ambulatory medicine is the ideal setting for the treatment of children and adolescent's obesity, it's also in proximity to the patients' residence, the medical team has a deep knowing of their patients and the possibility for long term maintenance and follow-up.

We propose a trial of obesity treatment by behavior modification program, including parents as agents of change.


Condition Intervention
Obesity Behavioral: dietary, behavioral, physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multidisciplinary Ambulatory Intervention Program (Dietary Behavioral Physical Activity) in Family of Children and Adolescents With Obesity

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • changes in BMI, activity level and Quality of Life questionnaire for the parents and the others children in the family

Estimated Enrollment: 40
Study Start Date: September 2006
Study Completion Date: August 2009
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:Children (6-18 years) with BMI in the 85th to 95th percentile or higher

Exclusion Criteria:Children with chronic diseases treated with chronic medications.

Refuse to participate in to the study

  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): NCT00344747


Locations
Israel
Clalit Health Services,
Beer Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Gherta Bril, MD BGU
  More Information

ClinicalTrials.gov Identifier: NCT00344747     History of Changes
Other Study ID Numbers: SOR433806CTIL
First Submitted: June 25, 2006
First Posted: June 27, 2006
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Soroka University Medical Center:
intervention program
diet
physical activity
adolescents
obesity

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