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Childhood Obesity-A Study of Intervention

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ClinicalTrials.gov Identifier: NCT01681108
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : September 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for children and adolescents to lose weight and promote their self esteem in a fun atmosphere.

Condition or disease Intervention/treatment
Obesity Behavioral: Lifestyle counseling

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Childhood Obesity-A Study of Intervention
Study Start Date : June 2006
Primary Completion Date : December 2011
Study Completion Date : December 2011
Arms and Interventions

Arm Intervention/treatment
Lifestyle counseling
Individualized meal planning and exercise regimen sessions will be developed for each participant
Behavioral: Lifestyle counseling
Individualized meal planning and exercise regimen sessions will be developed for each participant


Outcome Measures

Primary Outcome Measures :
  1. BMI will be measured [ Time Frame: 3 month interval over 1 year ]
    Data will be collected at routine office visits


Secondary Outcome Measures :
  1. Weight [ Time Frame: 3 month interval over 1 year ]
    Data will be collected at routine office visits

  2. Height [ Time Frame: 3 month interval over 1 year ]
    Data will be collected at routine office visits


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adolescents between the ages of 8 and 16 years with a BMI > 85th%.

Exclusion Criteria:

  • Children younger then 8 years of age or older then 16 years of age.
  • Children with a BMI < 85th%
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): NCT01681108


Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Siham Accacha, MD Winthrop University Hospital
More Information

Responsible Party: Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01681108     History of Changes
Other Study ID Numbers: 06304
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

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