NCT00344747

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable obesity

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

First Submitted

Initial submission to the registry

June 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

First QC Date

June 25, 2006

Last Update Submit

September 19, 2010

Conditions

Keywords

intervention programdietphysical activityadolescentsobesity

Outcome Measures

Primary Outcomes (1)

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

Interventions

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Refuse to participate in to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services,

Beersheba, Israel

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gherta Bril, MD

    BGU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2006

First Posted

June 27, 2006

Study Start

September 1, 2006

Study Completion

August 1, 2009

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations