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Childhood Obesity-A Study of Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01681108
First received: March 28, 2011
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Obesity
 Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Childhood Obesity-A Study of Intervention

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • BMI will be measured [ Time Frame: 3 month interval over 1 year ] [ Designated as safety issue: No ]
    Data will be collected at routine office visits


Secondary Outcome Measures:
  • Weight [ Time Frame: 3 month interval over 1 year ] [ Designated as safety issue: No ]
    Data will be collected at routine office visits

  • Height [ Time Frame: 3 month interval over 1 year ] [ Designated as safety issue: No ]
    Data will be collected at routine office visits


Enrollment: 6
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01681108     History of Changes
Other Study ID Numbers: 06304
Study First Received: March 28, 2011
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013