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临床试验/NCT01681108
NCT01681108已完成不适用

Childhood Obesity-A Study of Intervention

Winthrop University Hospital2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
BMI will be measured

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents between the ages of 8 and 16 years with a BMI > 85th%.

排除标准

  • Children younger then 8 years of age or older then 16 years of age.
  • Children with a BMI < 85th%

结局指标

主要结局

BMI will be measured

时间窗: 3 month interval over 1 year

Data will be collected at routine office visits

次要结局

  • Weight(3 month interval over 1 year)
  • Height(3 month interval over 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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