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临床试验/NCT01662271
NCT01662271已完成不适用

Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study

Prof. Dr. Martin Wabitsch5 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
429
试验地点
5
主要终点
adherence with structured care

研究概览

简要总结

The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life, psychosocial situation, and health of the affected youth. However, as few of these adolescents seek medical care, little is known about the longitudinal course of adolescent extreme obesity.

In this study, the investigators aim to provide structured care for adolescents with obesity and extreme obesity over a prolonged period of time, and to gain information on the course of obesity and the success of different treatment options. The study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with Extreme obesity Study (YES)", which aims at improving the medical care and social support structures for youth with obesity and extreme obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially up to 21 years) are eligible to participate. Participants will have a physical check-up every 12 months (initially every 6 months), complete questionnaires on their health, socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to assess comorbidities. Participants are offered support and guidance for social and vocational integration. The study will evaluate and inform treatment and support options for adolescents with extreme obesity.

详细描述

Little is known about the longitudinal course of adolescent extreme obesity. In this multicenter study, the investigators aim to enroll adolescents with extreme obesity (BMI ≥ 35kg/m2) in a 9 year longitudinal, prospective observation that will reveal information on the course of obesity and the success of different treatment options. Adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2) will serve as a control group. The project builds on the Consortium "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with extreme obesity Study (YES)", which comprises the recruitment and characterization of obese youth from different healthcare- and non healthcare settings, a randomized controlled trial to investigate a novel intervention targeted at improving quality of life and social functioning of extremely obese adolescents, a structured prospective evaluation of adolescent bariatric surgery, and economic assessments of the financial burden of extreme adolescent obesity on the healthcare system.

Based on the current state of knowledge, the investigators have formulated the following a priori hypotheses in regards to the longitudinal observation study:

  1. Youth with extreme obesity (BMI ≥ 35kg/m2) achieve lower adherence with the structured care program compared to adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2).
  2. Youth with extreme obesity (BMI ≥ 35kg/m2) are less likely to achieve and sustain weight loss over a prolonged period of time, compared to adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2).
  3. Youth with extreme obesity (BMI ≥ 35kg/m2) are harder to integrate in the job market compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).
  4. Youth with extreme obesity (BMI ≥ 35kg/m2) have higher incidence and severity of co-morbidities compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).

The investigators aim to recruit a total of 600 adolescents age 14 to 24.9 years (initial age up to 21 years; changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. The five participating university centers are distributed across 4 geographic regions in the North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of Germany, and will therefore render data that are representative of Germany as a whole. Adolescent will be examined annually (initially examinations were biannually, this was changed in an amendment in December 2014), and testing will include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life, as well as a physical examination, laboratory tests, and screenings for orthopedic co-morbidities and sleep apnea. Participants are offered support and guidance in regards to social and vocational integration with the aim of improving self esteem and social functioning. Data will be entered in an extended version of the "German National Register for Longitudinal Research on Childhood Obesity". We will perform sub-analyses based on the treatment options these youths have followed The project will reveal the acceptance and outcomes of a structured healthcare program for adolescents with extreme obesity and provide unique information on the medical and psychosocial development of adolescents with extreme obesity in Germany.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥ 30kg/m2
  • sufficient German language skills

排除标准

  • 未提供

结局指标

主要结局

adherence with structured care

时间窗: 12 months after subject inclusion

The percentage of subjects that comply with the structured follow up program will be calculated once a year.

次要结局

  • percentage of subjects that can be integrated into the job-market or into an apprenticeship training position(every 12 months for 9 years)
  • percentage of subjects that undergo the recommended diagnostic procedures(every 12 months for 9 years)
  • incidence of extreme obesity(every 12 months for 9 years)
  • predictors of the above outcomes(every 12 months for 9 years)
  • changes in somatic co-morbidities(every 12 months for 9 years)
  • changes in psychiatric co-morbidities(every 12 months for 9 years)
  • changes in health related quality of life(every 12 months for 9 years)
  • compliance with treatment of somatic co-morbidities(every 12 months for 9 years)
  • compliance with treatment of psychiatric co-morbidities(every 12 months for 9 years)
  • changes in socio-economic status(every 12 months for 9 years)
  • changes in BMI-SDS(every 12 months for 9 years)
  • adherence with structured care(every 12 months from 2-9 years post enrollment)

研究者

发起方
Prof. Dr. Martin Wabitsch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Martin Wabitsch

Division Chief Pediatric Endocrinology and Diabetology

University of Ulm

研究点 (5)

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