Childhood Obesity-A Study of Intervention
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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

        1. 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.

        2. 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:

        1. Individualized meal planning and exercise regimen sessions will be developed for each
           participant. .

        2. 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.

        3. 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.

        4. 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.
    

Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): Individualized meal planning and exercise regimen sessions will be developed for each participant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment