non commercial use only

Transcrição

non commercial use only
Appendix
Members of the EvAKuJ Study Group were (in alphabetical order):
Prof. M. Bullinger (Hamburg), Dr. A. van Egmond Fröhlich (Wien), Dr. U. Hoffmeister (Ulm),
Prof. R. Holl (Ulm), Prof. U. Ravens-Sieberer (Hamburg), Prof. T. Reinehr (Datteln), Prof. J.
Westenhöfer (Hamburg), and N. Wille (Hamburg).
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Actively participating providers of treatment programmes were (in alphabetical order):
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Adipositaszentrum (Oberhausen), Bella Bimba Maxi Power (Bad Segeberg), BKK Essanelle
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(Hannover), Bunter Kreis-Nachsorgezentrum (Augsburg), Charité Kinderklinik (Berlin),
Deutsche Klinik für Diagnostik/ Kinderheilkunde (Wiesbaden), Ernährungsmedizinisches
Zentrum (Braunschweig), Fachklinik für Kinder und Jugendliche "Am Wellengarten" (Bad
Fachklinik“
Am
Hochwald“
(Bruchweiler),
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Rothenfelde),
FITOC-Adipositasprogramm
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(Freiburg), Helios-Klinik Pädiatrie (Gotha), Institut für Kreislaufforschung und Sportmedizin der
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Deutschen Sporthochschule (Köln), Katholisches Kinderkrankenhaus Wilhelmstift (Hamburg),
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Kinderhospital (Osnabrück), Kinder- und Jugendpsychatrische Praxis (Rendsburg), Kinderklinik
(Datteln), Kinderklinik der Stadt Köln (Köln), Kinderklinik Dritter Orden (Passau), Kinderklinik
Kohlhof – Sozialpädiatrisches Zentrum (Neunkirchen), Kinderklinik (Salzgitter), Kinderleicht
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Adipositasschulung (Paderborn), Kindersportschule und BigKids Kinderarztpraxis (Böblingen),
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Klinik für Kinder- und Jugendmedizin (Bad Hersfeld), Klinik für Kinder und Jugendmedizin
(Ulm), Kinderklinik Bremen-Nord (Bremen), KOALA-Adipositasschulungsprogramm der
Kinderklinik (Lörrach), Kinderkrankenhaus (Dorsten), Gesundheitsamt (Düren), Spessart-Klinik
(Bad
Orb),
Moby
Dick
(Hamburg),
Moby-Dick
Ernährungsberatung
(Munster),
Ostseestrandklinik Klaus Störtebeker (Bad Kölpinsee), Paritätisches Sozialpädiatrisches Zentrum
Mops fidel (Berlin), Präventions-Erziehungs-Programm (PEP) (Nürnberg), Praxis für Diät- und
Ernährungsberatung (Zwickau), Praxis für Ernährungsberatung (Gröbenzell), Praxis für
Ernährungsberatung "Issgut" (Düsseldorf), Praxis für Ernährungsberatung Kilokids (Oldendorf),
Praxis für Ernährungsberatung (Waltrop), Praxis für Ernährungsberatung und –therapie
(Bensheim),
Praxis
für
Ernährungsberatung
und
–therapie
(Schliengen),
Praxis
für
Ernährungsmedizin (Herne), Praxis für Ernährungstherapie (Bühl), Rehaklinik "Charlottenhall"
(Bad
Salzungen),
Sozialpädiatrisches
Zentrum
(Göttingen);
Universtitäts-Kinderklinik
(Erlangen), Universitäts Kinderklinik Fit Kids/ christliches Jugenddorf (Homburg), Zentrale für
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Ernährungsberatung Hochschule für Angewandte Wissenschaften (Hamburg).
Publications of the EvAKuJ Study Group [summarized in reference 10]
a. Reinehr T, Hoffmeister U, Mann R, Goldapp C, Westenhöfer J, Egmond-Fröhlich A, Bullinger
M, Ravens-Sieberer U, Holl RW. Medical care of overweight children under real-life conditions:
the German BZgA observation study. Int J Obes (Lond). 2009; 33:418-23.
b. Hoffmeister U, Bullinger M, van Egmond-Fröhlich A, Goldapp C, Mann R, Ravens-Sieberer
U, Reinehr T, Westenhöfer J, Holl RW. Beobachtungsstudie der BZgA zur Adipositastherapie
bei Kindern und Jugendlichen in Deutschland: Anthropometrie, Komorbidität und Sozialstatus.
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Klin Pädiatr. 2010;222:274-8.
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c. Wille N, Bullinger M, Holl RW, Hoffmeister U, Mann R, Goldapp C, Reinehr T, Westenhöfer
J, van Egmond-Fröhlich A, Ravens-Sieberer U. Health-related quality of life in overweight and
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obese youths: Results of a multicenter study. Health and Quality of Life Outcomes. 2010. [cited
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2012 Sept 29]. 8:36. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2868813/
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d. Flechtner-Mors M, Thamm M, Rosario AS, Goldapp C, Hoffmeister U, Mann R, Bullinger M,
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van Egmond-Fröhlich A, Ravens-Sieberer U, Reinehr T, Westenhöfer J, Holl RW. Hypertonie,
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Dyslipoproteinämie und BMI-Kategorie charakterisieren das kardiovaskuläre Risiko bei
übergewichtigen oder adipösen Kindern und Jugendlichen. Daten der BZgA-Beobachtungsstudie
(EvAKuJ-Projekt) und der KiGGS-Studie. Klin Pädiatr. 2011;223:445–9.
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e. Hoffmeister U, Bullinger M, van Egmond-Fröhlich A, Goldapp C, Mann R, Ravens-Sieberer
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U, Reinehr T, Westenhöfer J, Wille N, Holl RW. Übergewicht und Adipositas in Kindheit und
Jugend: Evaluation der ambulanten und stationären Versorgung in Deutschland in der „EvAKuJStudie“. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010;54:128-35.
f. Hoffmeister U, Molz E, Bullinger M, van Egmond-Fröhlich A, Goldapp C, Mann R, RavensSieberer U, Reinehr T, Westenhöfer J, Wille N, Holl RW. Evaluation von Therapieangeboten für
adipöse Kinder und Jugendliche (EvAKuJ-Projekt): Welche Rolle spielen Behandlungskonzept,
AGA-Zertifizierung
und
initiale
Qualitätsangaben?
Gesundheitsforschung Gesundheitsschutz. 2011;54:603-10.
Bundesgesundheitsblatt
Glossary of terms and abbreviations and their definitions used in data analysis and
reporting
BMI-SDS: the body-mass-index standard deviation score is used to characterize the BMI of an
individual patient independently of her or his chronological age. The BMI is expressed in relation
to sex- and age-specific reference values. A value of +1.0 indicates that the measured BMI is one
standard deviation above the 50th percentile for her or his chronological age.
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Short-term effect: Difference in BMI-SDS between measurements at the time points T0 and T1.
Medium-term effect: Difference in BMI-SDS between measurements at the time points T0 and
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T2.
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Long-term effect: Difference in BMI-SDS between measurements at the time points T0 and T3.
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Drop-out: all patients who were included in the EvAKuJ study and did not complete the
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"drop-out".
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assigned intervention or did not present at the first assessment at its end (T1) were counted as
Loss-to-follow-up: all patients who were included in the EvAKuJ study, completed the assigned
intervention, and presented at the first assessment at its end (time point T1), but did not deliver
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information on BMI-SDS at the following assessments either one year (time point T2) or two
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years (time point T3) later were counted as "loss-to-follow-up".
"Intention-to-treat" (ITT)-analysis: data from all patients who were included at baseline with
the intention to treat (i.e., to complete the assigned intervention) were included into final analysis
and calculation of treatment success rates. It was not possible to control whether the assigned
intervention was delivered to the patients completely and as planned. The numbers of missing
values due to "drop-out" und "loss-to-follow-up" are shown separately.
Analysis "per protocol" (pP): only data from those patients were included into analysis and
calculation of treatment success rates who completed the assigned intervention and delivered
follow-up information on BMI-SDS (complete case analysis).
(Treatment-)Cluster: different types of treatment strategies used in complex health
interventions for overweight and obese children and adolescents and identified by a research
team at the Federal Centre for Health Education (BZgA) in Germany in 2005. Interventions in
cluster A consisted in inpatient treatment in a pediatric rehabilitation hospital, during
interventions in cluster B outpatient treatment preceeded by an inpatient treatment phase was
offered, and interventions in cluster C provided outpatient treatment by a multidisciplinary team.
In cluster D outpatient treatment was focussing on nutritional aspects, in cluster E on physical
activity and sports, and in cluster F mainly behavioral aspects of treatment were adressed.
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(Treatment-)Setting: during post-hoc final data analysis, treatment clusters were grouped into
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one of two treatment settings: they were classified as either ambulatory treatment of at least 3
months' duration (outpatient setting, long treatment) or as hospital-based treatment of less than 3
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e
months' duration (mostly inpatient setting, short treatment).
Control event rate (CER): the relative frequency of a (desired) effect (commonly attributed to
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specific treatment), which occurs spontaneously in untreated patients over time25.
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Odds: a ratio of the number of patients presenting a specific effect (either occurring
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spontaneously or related to treatment) to the number of patients not presenting it25.
Odds ratio (OR): the ratio of odds of presenting the specific effect in the treatment group
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relative to the odds in favor of presenting it in the control group25.
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Number needed to treat (NNT): the number of patients who need to be treated to achieve one
additional favorable outcome.
Description of interventions for inpatient and outpatient treatment of obesity in children
and adolescents studied during the EvAKuJ study according to Perera et al. (ref 16).
Components of complex interventions represented by squared brackets [...] are objects of fixed
nature, those represented by parentheses (...) are flexible activities. Components delivered
concurrently are shown side by side, those delivered consecutively are displayed one beneath the
other. Shaded areas indicate the main difference in the timeline between both treatments:
outpatients were treated for nearly one year, while inpatients received treatment for
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approximately 5 weeks.
Inpatient Treatment
Outpatient Treatment
Recruitment of Treatment Centers
(a)
(a)
Recruitment of Patients
(b)
(b)
[c]
(d) (e)
(g) (h) (i) (j) (k)
[l] [m]
[n]
(o) (p) [q]
{
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End-of-Intervention for Inpatients
(Time-point T1)
Duration of Inpatient Treatment
(mean ± standard deviation)
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Month 1 to 3
Month 4 to 12
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{
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Baseline (Time T0)
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Time Line
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End-of-Intervention for Outpatients
(Time-point T1)
Duration of Outpatient Treatment
(mean ± standard deviation)
1 year after End-of-Intervention
(Time-point T2)
2 years after End-of-Intervention
(Time-point T3)
{
[c]
(d) (e) [f]
(g) (h) (i) (j) (k)
[l] [m]
1.2 ± 0.5 months
(g) (h) (i) (j) (k)
[l] [m]
[n]
(o) (p) [q]
{
{
10.2 ± 4.8 months
{
{
(o) (p)
[q]
(o) (p)
[q]
(o) (p)
[q]
(o) (p)
[q]
Explanation of the symbols:
(a)
Treatment centers were registered by the study center in order to have access to the APV
software.
Initial medical visit: the treating physician (pediatrician, general practitioner) admitted the
individual patients needing intensified obesity treatment to one of the treatment centers
(b)
according to the criteria described in the national consensus statemen5 using
anthropometrical data to calculate BMI-SDSLMS and measurements of blood pressure, lipid
profile and fasting glucose level.
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Questionnaires had to be completed by the patient or a parent before starting treatment in
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order to elicit details on nutrition, eating and drinking habits, exercise behavior,
socioeconomic status, psychological situation, and health-related quality of life. At least
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e
[c]
one out of three questionnaires had to be completed in order to be eligible for the study.
Data retrieved from the initial medical visit were uploaded into the APV software by the
treatment center, eventually completing the initial data set transferred by the treating
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(d)
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In an initial group session, patients were introduced to the treatment scheme presenting the
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(e)
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physician.
treatment center and staff, and explaining the weekly timetable.
A work book is given to patients and their parents which explains the treatment plan using
cognitive behavioral techniques aimed at reducing overweight by changing habits
regarding eating, drinking and nutrition, daily physical activity and sports, as well as
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[f]
games.
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leisure time activities such as TV watching and usage of personal computers and video
Patient educational sessions on eating, drinking and nutrition of each 45 minutes duration;
inpatients received 79,5 sessions (median; inter quartile range 28 to 144), outpatients
received 18 (6 to 34) sessions. The teaching module on eating, drinking and nutrition
(g)
consisted of sessions on the physiology of eating and drinking, on food science, on eating
behavior including self-observation using a diary, as well as sensory training, cooking, and
special events, e.g., eating out in a restaurant, having a party, or buying food at the
(super)market.
(h)
Patient educational sessions on physical activity and sports of each 45 minutes duration;
inpatients received 78 (50 to 89) sessions, outpatients 39,5 (11 to 82). The teaching module
on physical activity and sports covered activities of daily living, physical self perception,
mobility, playing and sports. Specific knowledge and capabilities regarding team sports
and individual sports were addressed as were orthopedic aspects such as postural training
and joint protection. An introduction was given into physical strain and energy balance of
different kinds of activities.
Patient educational sessions on behavioral training of each 45 minutes duration; inpatients
received 18 (10 to 18) sessions, outpatients 13 (5 to 18). The sessions covered physical and
(i)
psychological self perception of mood and feelings related to eating and movement,
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training in self acceptance and social competence, treatment planning and prevention of
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relapse, as well as living in balance including use of relaxation techniques.
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Patient educational sessions on medical knowledge and facts of each 45 minutes duration;
inpatients received 7 (5 to 8) sessions, outpatients 3 (2 to 6). The sessions gave a definition
(j)
of obesity, informed about complications and consequences of overweight and ist causes
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and triggers. Treatment options and perspectives of the participants were covered including
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the reflection on previous treatment failures.
Educational sessions with parents of each 45 minutes duration; inpatients received 1
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session (0 to 2), outpatients 19 (6 to 32). During the sessions parents were informed on the
medical background of obesity and on the main topics of the sessions on nutrition, eating,
physical activity and sports delivered to the patients. The specific role of parents in
promoting self perception and self acceptance of their children as well as their contribution
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(k)
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to motivation and realistic planning of targets and aims during obesity treatment was
covered, as well as promotion of competence in parenting and recruitment of resources in
their families.
Patient's diary for documentation of food and beverage consumption (including
[l]
information on special events such as dining out etc.) was handed out during the initial
educational session on eating, drinking and nutrition; its use was reflected during the
following sessions.
Patient's diary for documentation of physical activity, sports, and leisure time activity was
[m] handed out during the initial educational session on physical activity and sports; its use
was reflected during the following sessions.
In a final group session, patients and their parents were alloded for adherence to the
(n)
treatment scheme by treatment center representatives and staff; hints for long-term
preservation or amplification of treatment success were given to the participants.
(o)
(p)
Medical follow-up-visit collecting anthropometrical data to calculate BMI-SDSLMS and
actual data on blood pressure, lipid profile and fasting glucose level.
Data retrieved from the medical follow-up-visits were uploaded into the APV software by
the treatment center.
Patients or their parents were asked to complete questionnaires on nutrition, eating and
drinking habits, exercise behavior, socioeconomic status, psychological situation, actual
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body weight and standing height, and health-related quality of life.
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[q]

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