Identification and Characterization of Youth With Extreme Obesity

Obesity Clinical Trial

— YES  

Official title:

Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625325
• Other study ID #: U1111-1131-4384a
• Secondary ID: DRKS0000417201GI
• Status: Completed
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2018
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

While obese and extremely obese youth are at increased risk of health complications, especially the extremely obese group rarely seek medical care. One of the underlying reasons might be the lack of adequate treatment options. This study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care study", 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. In this subproject, information on the causes and consequences of extreme obesity will be gathered via questionnaires and medical examinations.

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 be asked to complete a series of questionnaires on their general health, psychosocial situation and wellbeing in 2-3 sessions. They will be offered a thorough medical examination comprising a general check-up, a fasting blood draw and oral glucose tolerance test, a focused orthopaedic examination, a sleep apnea screening, and an ultrasound of the liver. The aim of the study is to elicit the acceptance of diagnostic and therapeutic procedures, and to assess the frequency of co-morbidities in obese and extremely obese youth. This knowledge will optimize medical treatment and support options. Interested participants will be invited to participate in further steps of YES, which entail medical care and psycho-social support.

Description:

In this multicenter study, we aim to recruit adolescents from various medical and non-medical settings and examine their acceptance of diagnostic and subsequent treatment procedures. We will compare the prevalence rates and severity of co-morbidities between adolescents with extreme obesity (BMI ≥35kg/m2)and those with less severe obesity (BMI 30-34.9kg/m2). This project is part of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care study", short: "Youth with extreme obesity Study (YES)", which also comprises 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, we have formulated the following hypotheses in regards to baseline characteristics:

1. The prevalence of somatic, psychiatric and psycho-social co-morbidities is higher, and health related quality of life is lower in extremely obese youth compared to the control group.

2. The prevalence of somatic co-morbidities is equal in treatment-seeking and non treatment-seeking youth.

3. The prevalence of psychiatric co-morbidities is higher and health related quality of life is lower in treatment-seeking compared to non treatment-seeking youth.

4. The acceptance of diagnostic and therapeutic procedures is lower in extremely obese youth compared to the control group.

5. The acceptance of diagnostic and therapeutic procedures is lower in non treatment-seeking- compared to treatment-seeking youth.

6. Socio-economic status, intelligence and educational status are predictors of treatment seeking behaviour and of the acceptance of diagnostic and therapeutic procedures.

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. We will recruit a total of 600 adolescents age 14 to 24.9 years (initial age 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. Baseline assessments include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life (in the amendment in February 2013, the scope of psychosocial questions was reduced), as well as a physical examination, laboratory tests, liver ultrasound, and screenings for orthopedic co-morbidities and sleep apnea. Subjects who participate in the baseline examination will be invited to participate in the subsequent components of YES.

The project will reveal comorbidity rates and psycho-social situation, and demonstrate the acceptance and outcomes of a structured healthcare program for adolescents with extreme obesity. The planned subsequent longitudinal study will provide unique information on the medical and psychosocial development of adolescents with extreme obesity in Germany.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

• BMI =30kg/m2

• sufficient German language skills

Exclusion Criteria:

Related Conditions & MeSH terms

• Extreme Obesity
• Obesity

Locations

Country	Name	City	State
Germany	Ambulatory Obesity Program, Charité University, Berlin	Berlin
Germany	Vestische Kinderklinik, University of Witten/Herdecke	Datteln
Germany	University Duisburg-Essen	Essen
Germany	University Hospital Leipzig	Leipzig
Germany	Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic	Ulm

Sponsors (5)

Lead Sponsor	Collaborator
Prof. Dr. Martin Wabitsch	Charite University, Berlin, Germany, Universität Duisburg-Essen, University of Leipzig, University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects that participate in the fasting blood draw	Subjects will be offered a diagnostic blood draw. The percentage of subjects that undergo this blood draw will be calculated.	baseline
Secondary	Predictors of the acceptance of the diagnostic procedures		baseline
Secondary	Prevalence of obesity associated psychiatric co-morbidities	Co-morbidities will be assessed via validated patient questionnaires.	baseline
Secondary	Percentage of patients that accept treatment of somatic co-morbidities	Appropriate medical treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who initiate such therapy will be calculated.	baselin
Secondary	Predictors of acceptance of treatment of co-morbidities		baseline
Secondary	Health related quality of life	assessed by validated questionnaire EQ5D	baseline
Secondary	Socio-economic status	Assessed by standardized questionnaire.	baseline
Secondary	Prevalence of obesity associated somatic co-morbidities	Co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.	baseline
Secondary	Percentage of patients that accept treatment of psychiatric co-morbidities	Appropriate medical treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who initiate such therapy will be calculated.	baseline
Secondary	Percentage of subjects that initiate a standardized low key intervention	All subjects will be offered the participation in a low key intervention as described in subproject two. The percentage of patients that accept and initiate this intervention will be calculated.	baseline
Secondary	Percentage of subjects that participate in diagnostic procedures.	Subjects will be offered a diagnostic liver ultrasound, sleep apnea screening, orthopedic screening, and an array of questionnaires to assess somatic- and psychiatric co-morbidities, psycho-social situation and health related quality of life. The percentage of subjects that comply with these diagnostic procedures beyond the initial visit will be calculated.	baseline

External Links

•   study homepage