Obesity Clinical Trial
Official title:
Structured Low-level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents With Extreme Obesity, Subproject 2
While adolescents with obesity and extreme obesity are at increased risk for health
complications, especially adolescents with extreme obesity rarely seek medical care, and
sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack
of adequate treatment options.
In this multicenter study, we aim to test a new, low key group intervention focusing on
improving compliance and psychosocial functioning. 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 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 be asked to complete a series
of questionnaires on their general health, psychosocial situation and wellbeing, and will be
offered a thorough medical evaluation. Individuals who complete the baseline evaluations will
be invited to participate in 6 group sessions over a 3 months period. Group assignment to the
psycho-social intervention vs. routine care group will be at random, like throwing a dice.
After 6 months, participants will complete further questionnaires to evaluate the effects of
the interventions on quality of life and psycho-social functionning.
The study will show the acceptance and effectiveness of a new intervention focusing on
improving compliance and psychosocial functioning in adolescents with extreme obesity, and
thereby inform the development of new treatment and support options for these adolescents. If
interested, participants are invited to participate in additional components of YES, and to
receive medical care and psycho-social support.
While obese youth are at high risk for co-morbidities, especially the extremely obese
individuals rarely seek medical care. The underlying reasons are poorly understood, but
patient inherent factors and the lack of adequate treatment options may play a role.
In this multicenter study, we aim to assess the acceptance and effectiveness of a manual
based low key group intervention focusing on improving compliance and psychosocial
functioning in adolescents with morbid obesity (BMI≥35kg/m2), in comparison to routine care.
Youth with more moderate degrees of obesity (BMI 30-34.9kg/m2) will serve as an additional
control group. The study is part of the Medical and psychosocial implications of adolescent
extreme obesity - acceptance and effects of structured care", short: "Youth with extreme
obesity Study (YES), which also 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 structured prospective evaluation of adolescent bariatric surgery,
economic assessments of the financial burden of extreme adolescent obesity on the healthcare
system, and a long-term prospective observation study.
Based on the current state of knowledge, we will test the a priori ordered hirarchy of
hypotheses:
1. The compliance rate 6 months after randomization is higher in subjects in the low key
intervention group compared to the standard care group.
2. Covariant-adjusted changes in quality of life (assessed by DISABKIDS scale) between
baseline and the 6 months follow up will be more pronounced in the low key intervention
group compared to the standard care group.
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 screen a 600 adolescents age 14 to 24.9 years (initially up to 21 years; this was
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. A total of 350 subjects
will be enrolled. 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, as well as an in-depth medical evaluation. Individuals
who complete the baseline evaluations will be invited to participate in 6 group sessions over
a 3 months period. Group assignment to the low key intervention vs. standard care group will
be at random. The effects of the interventions on health related quality of life and
psycho-social functioning will be assessed via questionnaires after 6 months. Subsequently,
subjects will be invited to participate in additional components of YES.
The project will reveal the effectiveness and safety of a manual based low key group
intervention focusing on improving compliance and psychosocial functioning in adolescents
with morbid obesity, and thereby inform the development of new treatment and support options
for these adolescents in Germany.
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