Clinical trial NCT01625325: Identification and Characterization of Youth With Extreme Obesity
Official title: Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Extreme Obesity
Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: University of Witten/Herdecke
name: Charite University, Berlin, Germany
name: University of Leipzig
name: Universität Duisburg-Essen
First posted: 2012-06-21
Enrollment: 429
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the general population through different healthcare- and non healthcare settings to ascertain the inclusion of treatment-seeking and non treatment-seeking individuals. Healthcare settings include university based obesity clinics, physician offices and health insurance agencies. Non-healthcare settings include schools, job centers, and employment agencies.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of subjects that participate in the fasting blood draw
timeFrame: baseline
Secondary outcomes:
measure: Predictors of the acceptance of the diagnostic procedures
timeFrame: baseline
measure: Prevalence of obesity associated psychiatric co-morbidities
timeFrame: baseline
measure: Percentage of patients that accept treatment of somatic co-morbidities
timeFrame: baselin
measure: Predictors of acceptance of treatment of co-morbidities
timeFrame: baseline
measure: Health related quality of life
timeFrame: baseline
measure: Socio-economic status
timeFrame: baseline
measure: Prevalence of obesity associated somatic co-morbidities
timeFrame: baseline
measure: Percentage of patients that accept treatment of psychiatric co-morbidities
timeFrame: baseline
measure: Percentage of subjects that initiate a standardized low key intervention
timeFrame: baseline
measure: Percentage of subjects that participate in diagnostic procedures.
timeFrame: baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Ambulatory Obesity Program, Charité University, Berlin
city: Datteln
country: Germany
facility: Vestische Kinderklinik, University of Witten/Herdecke
city: Essen
country: Germany
facility: University Duisburg-Essen
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Ulm
country: Germany
facility: Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Study officials:
affiliation: University of Ulm
name: Martin Wabitsch, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Susanna Wiegand, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Witten/Herdecke
name: Thomas Reinehr, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universität Duisburg-Essen
name: Johannes Hebebrand, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig
name: Wieland Kiess, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulm
name: Reinhard Holl, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulm
name: Anja Moss, Dr. biol. hum.
role: STUDY_DIRECTOR
affiliation: University of Ulm
name: Belinda S Lennerz, Dr. med.
role: STUDY_DIRECTOR
affiliation: University of Ulm
name: Julia von Schnurbein, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Felix J, Stark R, Teuner C, Leidl R, Lennerz B, Brandt S, von Schnurbein J, Moss A, Bollow E, Sergeyev E, Muhlig Y, Wiegand S, Holl RW, Reinehr T, Kiess W, Scherag A, Hebebrand J, Wabitsch M, Holle R. Health related quality of life associated with extreme obesity in adolescents - results from the baseline evaluation of the YES-study. Health Qual Life Outcomes. 2020 Mar 5;18(1):58. doi: 10.1186/s12955-020-01309-z.
citation: Wabitsch M, Moss A, Reinehr T, Wiegand S, Kiess W, Scherag A, Holl R, Holle R, Hebebrand J. Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care, short: Youth with Extreme Obesity Study (YES). BMC Public Health. 2013 Aug 29;13:789. doi: 10.1186/1471-2458-13-789.