Winthrop University Hospital
Mineola, New York, 11501, United States
NCT Number: NCT01681108
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.
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Notify Me8 year–16 year
All sexes
Interventional
Not applicable
Mineola, New York, 11501, United States
The Program will be divided into four areas: 1) Screening, 2) Implementation 3) Follow-up Post program, 4) Analysis
During the first three visits, a full medical evaluation will be performed and it will be determined if the potential patient meets study entry criteria. Body measurements, blood collection, family history, behavioral, cardiac, exercise and nutritional evaluations will take place. Glucose tolerance testing will be performed during screening. if HbA1c is above 5.2 to classify patients as euglycemic, hyperinsulinemic or Type 2 Diabetes. Other endocrine evaluations (e.g. FSH, LH, testosterone, Total T4, Free T4, andandT3, TSH for PCOS and/or thyroid hormone dysfunction) will be performed as medically indicated. And if medical problems are present, they there will be addressed and treated by an appropriately medical treatment. In case of PCOS medical treatment is not enough and diet and exercise should be always part of the treatment.
The design of the intervention is as follows:
Subsequent visits will occur every three months which is considered standard of care.
After years 1 and 2, the study team will evaluate the effectiveness of the program as a whole and each individual component. Recommendations for design changes, as well as statistical information from all study members (i.e., behavioral, nutrition, exercise) will be analyzed to determine the advantages of certain treatment modalities in the effective treatment of childhood obesity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individualized meal planning and exercise regimen sessions will be developed for each participant
Time frame: 3 month interval over 1 year
Data will be collected at routine office visits
Time frame: 3 month interval over 1 year
Data will be collected at routine office visits
Time frame: 3 month interval over 1 year
Data will be collected at routine office visits
Winthrop University Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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