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

Obesity Clinical Trial

Official title:

Multidisciplinary Ambulatory Intervention Program (Dietary Behavioral Physical Activity) in Family of Children and Adolescents With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344747
• Other study ID #: SOR433806CTIL
• Status: Completed
• Phase: N/A
• First received: June 25, 2006
• Last updated: September 19, 2010
• Start date: September 2006
• Est. completion date: August 2009

Study information

• Verified date: September 2010
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• dietary, behavioral, physical activity

Locations

Country	Name	City	State
Israel	Clalit Health Services,	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in BMI, activity level and Quality of Life questionnaire for the parents and the others children in the family