Childhood Obesity-A Study of Intervention
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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%
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lifestyle counseling
Arm Description
Individualized meal planning and exercise regimen sessions will be developed for each participant
Outcomes
Primary Outcome Measures
BMI will be measured
Data will be collected at routine office visits
Secondary Outcome Measures
Weight
Data will be collected at routine office visits
Height
Data will be collected at routine office visits
Full Information
NCT ID
NCT01681108
First Posted
March 28, 2011
Last Updated
September 6, 2012
Sponsor
Winthrop University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01681108
Brief Title
Childhood Obesity-A Study of Intervention
Official Title
Childhood Obesity-A Study of Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Winthrop University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
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:
Individualized meal planning and exercise regimen sessions will be developed for each participant. .
Participants and their families will participate in groups of 10 to 12 where they can elicit support and motivation from one another, learn about nutrition, behaviors as well as engage in exercise programs which are facilitated by a certified instructor.
Weekly topics will be taught through 'gaming activities' designed to impart educational information through games and activities. Group support activities will use affective techniques in order to elicit sharing of feelings.
Each discipline involved- behavioral, nutritional and exercise physiology will design pre and post evaluation tools (in addition to maintaining histories on each participant) as well as lesson plans, gaming activities and affective techniques. Behavioral issues such as eating through boredom, stress, or loneliness, for example, might be addressed in varied ways weaved throughout the 2 ½ hr session, while portion control, appropriate food choices might be the nutritional topics covered that session and reviewed through gaming activities. The exercise portion of the lesson may address varied types of exercise to reduce stress and keep them busy and a yoga instructor may come that night to demonstrate other stress reduction techniques.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Other
Arm Description
Individualized meal planning and exercise regimen sessions will be developed for each participant
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
Individualized meal planning and exercise regimen sessions will be developed for each participant
Primary Outcome Measure Information:
Title
BMI will be measured
Description
Data will be collected at routine office visits
Time Frame
3 month interval over 1 year
Secondary Outcome Measure Information:
Title
Weight
Description
Data will be collected at routine office visits
Time Frame
3 month interval over 1 year
Title
Height
Description
Data will be collected at routine office visits
Time Frame
3 month interval over 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siham Accacha, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
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Childhood Obesity-A Study of Intervention
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