Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01632098 |
| Other study ID # |
U1111-1131-4384d |
| Secondary ID |
DRKS0000419701GI |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2012 |
| Est. completion date |
July 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Ulm |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
