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Completed

NCT Number: NCT01625325

Identification and Characterization of Youth With Extreme Obesity

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.

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Key information

Conditions

Obesity Body Weight Extreme Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ambulatory Obesity Program, Charité University, Berlin, Berlin, Germany

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About this study

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:

  • 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.
  • The prevalence of somatic co-morbidities is equal in treatment-seeking and non treatment-seeking youth.
  • 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.
  • The acceptance of diagnostic and therapeutic procedures is lower in extremely obese youth compared to the control group.
  • The acceptance of diagnostic and therapeutic procedures is lower in non treatment-seeking- compared to treatment-seeking youth.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Percentage of subjects that participate in the fasting blood draw

    Time frame: baseline

    Subjects will be offered a diagnostic blood draw. The percentage of subjects that undergo this blood draw will be calculated.

Secondary outcomes

  1. Predictors of the acceptance of the diagnostic procedures

    Time frame: baseline

  2. Prevalence of obesity associated psychiatric co-morbidities

    Time frame: baseline

    Co-morbidities will be assessed via validated patient questionnaires.

  3. Percentage of patients that accept treatment of somatic co-morbidities

    Time frame: baselin

    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.

  4. Predictors of acceptance of treatment of co-morbidities

    Time frame: baseline

  5. Health related quality of life

    Time frame: baseline

    assessed by validated questionnaire EQ5D

  6. Socio-economic status

    Time frame: baseline

    Assessed by standardized questionnaire.

  7. Prevalence of obesity associated somatic co-morbidities

    Time frame: baseline

    Co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.

  8. Percentage of patients that accept treatment of psychiatric co-morbidities

    Time frame: baseline

    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.

  9. Percentage of subjects that initiate a standardized low key intervention

    Time frame: baseline

    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.

  10. Percentage of subjects that participate in diagnostic procedures.

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Prof. Dr. Martin Wabitsch

Other

Collaborators

  • Charite University, Berlin, Germany
  • University of Leipzig
  • University of Witten/Herdecke
  • Universität Duisburg-Essen

Registry information

Official study title

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

Acronym: YES

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2012
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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