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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.
The Program will be divided into four areas: 1) Screening, 2) Implementation 3) Follow-up Post program, 4) Analysis
Screening Children between the ages of 8-16 years of age whose BMI>85th% will be identified and screened. The parent and their child must agree to participate in the entire study.
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.
Program Implementation Participants will be entered into the 10-week program. Each child will act as his/her own control and the success of the interventions will be measured in change in percentiles over time. Each group will contain no more than 12 participants. During the program there will be intensive nutrition, behavioral and exercise therapy designed specifically for each child and for each family participating. The program, designed for a total of 32 weeks, will include weekly sessions for the first 10 weeks, every other week for the next 10 weeks, and once a month thereafter.
The design of the intervention is as follows:
3) Follow-up Post Program After the 32-week program, there will be follow-up visits in order to assess maintenance of weight loss. Questionnaires and visits at 2 months, 6 months, and 1 year after the program ends will evaluate long-term success.
Subsequent visits will occur every three months which is considered standard of care.
4) Analysis: Pre 10 week session and post 10 week session the following evaluation tools and criteria will be evaluated: Weight, waist circumference, endurance, strength, flexibility, triceps caliper measurements as well as the YES evaluation. The Youth Evaluation Scale is a nationally standardized test. The YES evaluation is performed on ages 9 and > and evaluates areas such as: habits, knowledge, self esteem, depression, anxiety, family communications, lifestyle, structure and more.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Other | Individualized meal planning and exercise regimen sessions will be developed for each participant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle counseling | Behavioral | Individualized meal planning and exercise regimen sessions will be developed for each participant |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI will be measured | Data will be collected at routine office visits | 3 month interval over 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Data will be collected at routine office visits | 3 month interval over 1 year |
| Height | Data will be collected at routine office visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siham Accacha, MD | Winthrop University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 3 month interval over 1 year |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |