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ObesityYESNCT01632098

Economic Aspects of Extreme Obesity in Adolescent

An observational study of Obesity and Extreme Obesity, run by University of Ulm at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Obesity is one of the biggest public health challenges today and in the years to come, particularly due to its rising prevalence in children and adolescents. In addition to the increased health risks for each individual, obesity causes a tremendous economic burden on the healthcare system. Read more about this study

Who is it for?
Ages 14 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Extreme Obesity
How many people
429 participants
Where
5 sitesGermany
Study dates
Jul 2012to Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

  • none

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites
  • Ambulatory Obesity Program, Charité University, Berlin

    Berlin, 13353

  • Vestische Kinderklinik, University of Witten/Herdecke

    Datteln

  • University Duisburg-Essen

    Essen, 45147

  • University Hospital Leipzig

    Leipzig, 04103

  • Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

    Ulm, 89075

Other trials in Germany

About this study

Official title: Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 4

Obesity is one of the biggest public health challenges today and in the years to come, particularly due to its rising prevalence in children and adolescents. In addition to the increased health risks for each individual, obesity causes a tremendous economic burden on the healthcare system.

Here, the investigators will examine the impact of extreme obesity on healthcare utilization, costs, and health related quality of life in adolescents. The 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. 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 complete questionnaires to assess health related quality of life and utilization of healthcare. These questionnaires will be applied at baseline and then every 12 months (initially every 6 months) during health check-ups. As part of the other subprojects of YES, participants will be invited to complete further questionnaires and will be offered a thorough medical examination, medical care and psycho-social support.

The investigators expect to provide valid and up-to-date information on costs and health-related quality of life for obese adolescents. This information will help in the planning of useful and cost effective preventive and therapeutic strategies, and improve the medical care and support structures for obese adolescents.

Read the detailed description

Obesity is acknowledged as one of the biggest public health challenges today and in the years to come, particularly due to its rising prevalence in children and adolescents. In addition to the physical, mental and social health consequences of the obesity epidemic, a major concern that emanates from overweight and obesity is the related economic burden. Here, the investigators will invexamine the impact of extreme obesity (BMI ≥35kg/m2) on healthcare utilization, costs, and health related quality of life in a cohort of adolescents. Adolescents with more moderate obesity (BMI 30-34.9kg/m2) will serve as a control group. 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 comprises the recruitment and characterization of obese (BMI 30-34.9kg/m2) and extremely obese (BMI ≥35kg/m2) 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 a long-term prospective observation study.

Based on the current state of knowledge, the investigators have formulated the following hypotheses in regards to healthcare utilization, costs, and health related quality of life:

  1. Cost induced by utilization of healthcare services of adolescents with extreme obesity (BMI ≥ 35kg/m2) will be significantly higher compared to cost induced by adolescents with obese (BMI 30-34.9kg/m2). In adolescents who undergo bariatric surgery, cost will decrease after the intervention.
  2. Adolescents with extreme obesity (BMI ≥ 35) have significantly lower health related quality of life compared to adolescents with obesity (BMI 30-34.9kg/m2). After specific interventions (psycho-social intervention in subproject 2, bariatric surgery in subproject 3), health related quality of life will increase after the intervention.
  3. The cost of the surgical intervention will be accompanied by strong positive effects (such as relative weight loss and health related quality of life) Therefore bariatric surgery will be cost-effective.
  4. The high costs of bariatric surgery will be amortized by health savings due to decreased utilization of health care services and lower indirect costs in the medium to long term.

A total of 600 adolescents age 14 to 24.9 years (initially up to 21 years) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) will be recruited 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.

Utilization and healthcare costs associated with extreme obesity in adolescents will be assessed via standardized patient questionnaires. Health related quality of life associated with extreme obesity in adolescents will be assessed with validated instruments at baseline and then every 12 months (initially every 6 months). Cost-effectiveness and cost-utility analyses will be performed.

The investigators expect to provide valid and up-to-date information on healthcare costs and health-related quality of life for this relevant patient group. This information will inform the planning of future preventive and therapeutic strategies.

In February 2013, an amendment was added to the study to include patients up till 24.9 years. In addition, in an amendment in December 2014, the number of visits was reduced from biannually to annually and a travel-imbursement of 30€ for the patients was implemented.

Keywords
psychosocial, healthcare, co-morbidities, extremely obese adolescents
Medical subject headings
Obesity, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01632098
Study groupRoleWhat they receive
extremely obeseBMI ≥35kg/m2
obeseBMI 30-34.9kg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Economic burden of extreme obesity in adolescents living in Germany

    Resource utilization and calculate health care cost will be elicited using a standardized patient questionnaire that was developed and tested by the Helmholtz Zentrum München.

    Measured: baseline

Secondary outcomes (3)
  1. Health related quality of life associated with extreme obesity in adolescents

    Health related quality of life will be elicited via validated patient questionnairs (EQ5D, DISABKIDS).

    Measured: at baseline and every 12 months

  2. BMI

    weight in kg divided by height squared in meters

    Measured: at baseline and every 12 months

  3. Changes in economic burden of extreme obesity in adolescents living in Germany

    Resource utilization and calculate health care cost will be elicited using a standardized patient questionnaire that was developed and tested by the Helmholtz Zentrum München.

    Measured: every 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJul 2023
  4. Study completionJul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
429 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632098
Sponsor's protocol ID
U1111-1131-4384d
Other IDs
DRKS00004197, 01GI1127, U1111-1131-8145
Acronym
YES
Status last verified
May 2024
First submitted
22 Jun 2012
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23987123

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Extreme Obesity, run by University of Ulm at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Economic burden of extreme obesity in adolescents living in Germany (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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