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).
Actively participating providers of treatment programmes were (in alphabetical order):
Adipositaszentrum (Oberhausen), Bella Bimba Maxi Power (Bad Segeberg), BKK Essanelle (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 Rothenfelde), Fachklinik“ Am Hochwald“ (Bruchweiler), FITOC-Adipositasprogramm (Freiburg), Helios-Klinik Pädiatrie (Gotha), Institut für Kreislaufforschung und Sportmedizin der Deutschen Sporthochschule (Köln), Katholisches Kinderkrankenhaus Wilhelmstift (Hamburg), 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 Adipositasschulung (Paderborn), Kindersportschule und BigKids Kinderarztpraxis (Böblingen), 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"
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(Bad Salzungen), Sozialpädiatrisches Zentrum (Göttingen); Universtitäts-Kinderklinik (Erlangen), Universitäts Kinderklinik Fit Kids/ christliches Jugenddorf (Homburg), Zentrale für Ernährungsberatung Hochschule für Angewandte Wissenschaften (Hamburg).
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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. Klin Pädiatr. 2010;222:274-8.
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 obese youths: Results of a multicenter study. Health and Quality of Life Outcomes. 2010. [cited 2012 Sept 29]. 8:36. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2868813/
d. Flechtner-Mors M, Thamm M, Rosario AS, Goldapp C, Hoffmeister U, Mann R, Bullinger M, van Egmond-Fröhlich A, Ravens-Sieberer U, Reinehr T, Westenhöfer J, Holl RW. Hypertonie, 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.
e. Hoffmeister U, Bullinger M, van Egmond-Fröhlich A, Goldapp C, Mann R, Ravens-Sieberer 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 „EvAKuJ-Studie“. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010;54:128-35. f. Hoffmeister U, Molz E, Bullinger M, van Egmond-Fröhlich A, Goldapp C, Mann R, Ravens-Sieberer 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? Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011;54:603-10.
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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.
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 T2.
Long-term effect: Difference in BMI-SDS between measurements at the time points T0 and T3.
Drop-out: all patients who were included in the EvAKuJ study and did not complete the assigned intervention or did not present at the first assessment at its end (T1) were counted as "drop-out".
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 information on BMI-SDS at the following assessments either one year (time point T2) or two 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).
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(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.
(Treatment-)Setting: during post-hoc final data analysis, treatment clusters were grouped into 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 months' duration (mostly inpatient setting, short treatment).
Control event rate (CER): the relative frequency of a (desired) effect (commonly attributed to specific treatment), which occurs spontaneously in untreated patients over time25.
Odds: a ratio of the number of patients presenting a specific effect (either occurring 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 relative to the odds in favor of presenting it in the control group25.
Number needed to treat (NNT): the number of patients who need to be treated to achieve one additional favorable outcome.
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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 approximately 5 weeks.
Time Line Inpatient Treatment Outpatient Treatment
Recruitment of Treatment Centers (a) (a)
Recruitment of Patients (b) (b)
Baseline (Time T0) { [c] (d) (e) [c] (d) (e) [f]
Month 1 to 3 { (g) (h) (i) (j) (k)
[l] [m]
(g) (h) (i) (j) (k) [l] [m]
End-of-Intervention for Inpatients
(Time-point T1) {
[n]
(o) (p) [q] Duration of Inpatient Treatment
(mean ± standard deviation) 1.2 ± 0.5 months
Month 4 to 12 { (g) (h) (i) (j) (k) [l] [m]
End-of-Intervention for Outpatients
(Time-point T1) {
[n]
(o) (p) [q] Duration of Outpatient Treatment
(mean ± standard deviation) 10.2 ± 4.8 months
1 year after End-of-Intervention
(Time-point T2) {
(o) (p)
[q] (o) (p) [q]
2 years after End-of-Intervention
(Time-point T3) {
(o) (p) [q] (o) (p) [q]
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Explanation of the symbols:
(a) Treatment centers were registered by the study center in order to have access to the APV software.
(b)
Initial medical visit: the treating physician (pediatrician, general practitioner) admitted the individual patients needing intensified obesity treatment to one of the treatment centers 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.
[c]
Questionnaires had to be completed by the patient or a parent before starting treatment in order to elicit details on nutrition, eating and drinking habits, exercise behavior, socioeconomic status, psychological situation, and health-related quality of life. At least one out of three questionnaires had to be completed in order to be eligible for the study.
(d)
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 physician.
(e) In an initial group session, patients were introduced to the treatment scheme presenting the treatment center and staff, and explaining the weekly timetable.
[f]
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 leisure time activities such as TV watching and usage of personal computers and video games.
(g)
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 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;
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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.
(i)
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 psychological self perception of mood and feelings related to eating and movement, training in self acceptance and social competence, treatment planning and prevention of relapse, as well as living in balance including use of relaxation techniques.
(j)
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 of obesity, informed about complications and consequences of overweight and ist causes and triggers. Treatment options and perspectives of the participants were covered including the reflection on previous treatment failures.
(k)
Educational sessions with parents of each 45 minutes duration; inpatients received 1 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 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.
[l]
Patient's diary for documentation of food and beverage consumption (including 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.
[m]
Patient's diary for documentation of physical activity, sports, and leisure time activity was handed out during the initial educational session on physical activity and sports; its use was reflected during the following sessions.
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(n)
In a final group session, patients and their parents were alloded for adherence to the treatment scheme by treatment center representatives and staff; hints for long-term preservation or amplification of treatment success were given to the participants.
(o) Medical follow-up-visit collecting anthropometrical data to calculate BMI-SDSLMS and actual data on blood pressure, lipid profile and fasting glucose level.
(p) Data retrieved from the medical follow-up-visits were uploaded into the APV software by the treatment center.
[q]
Patients or their parents were asked to complete questionnaires on nutrition, eating and drinking habits, exercise behavior, socioeconomic status, psychological situation, actual body weight and standing height, and health-related quality of life.
