Adoption of The Children’s Obesity Clinic’s Treatment (TCOCT) Protocol into another Danish Pediatric Obesity Treatment Clinic 1
Running title: Childhood Obesity Treatment
2 3
SEBASTIAN W. MOST1, BIRGITTE HØJGAARD1, GRETE TEILMANN1,4, JESPER ANDERSEN1,4, METTE
4
VALENTINER1, MICHAEL GAMBORG2 & JENS-CHRISTIAN HOLM3,4
5 6
1
7
Hillerød, Denmark SWM:
[email protected] GT:
[email protected] JA:
8
[email protected] MV:
[email protected] BH:
[email protected]
9 10 11 12 13
The Children’s Obesity Clinic, Department of Pediatrics, Nordsjællands Hospital, Hillerød, Copenhagen University,
2
Institute of Preventive Medicine, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen,
Denmark MG:
[email protected] 3
The Children’s Obesity Clinic, Department of Pediatrics, Holbæk University Hospital, Holbæk, Denmark JH:
[email protected] 4
Institute of Internal Medicine, the Medical Faculty, University of Copenhagen, Denmark
14 15 16 17 18
Corresponding author:
19
Sebastian Wenzel Most, stud.med.
20
Department of Pediatrics, Nordsjællands Hospital, Hillerød
21
Dyrehavevej 29, DK-3400 Hillerød, Denmark
22
Phone: +45 27 21 07 60 e-mail:
[email protected]
1
23
Abstract
24
Background. Treating severe childhood obesity has proven difficult with inconsistent treatment results. This study
25
reports the results of the implementation of a childhood obesity chronic care treatment protocol.
26
Methods. Patients aged 5 to 18 years with a body mass index (BMI) above the 99th percentile for sex and age were
27
eligible for inclusion. At baseline patients’ height, weight, and tanner stages were measured, as well as parents’
28
socioeconomic status (SES) and family structure. Parental weight and height were self-reported. An individualised
29
treatment plan including numerous advices was developed in collaboration with the patient and the family. Patients’
30
height and weight were measured at subsequent visits. There were no exclusion criteria.
31
Results. Three-hundred-thirteen (141 boys) were seen in the clinic in the period of February 2010 to March 2013. At
32
inclusion, the median age of patients was 11.1 years and the median BMI standard deviation score (SDS) was 3.24 in
33
boys and 2.85 in girls. After 1 year of treatment, the mean BMI SDS difference was -0.30 (95% CI: -0.39; -0.21, p
102
BMI < 30), or being obese (BMI > 30) according to WHO guidelines [24]. Family structure was classified as follows,
103
by whom the patient was living with: (a) both parents, (b) disrupted family (i.e. single or divorced parents with or
104
without stepfamily), or (c) alternative family structures such as foster families, group homes, or with other family
105
members. The investigation and interview form is available from the authors.
106
Socioeconomic status (SES) was defined in groups of 1 – 5 based on the National Statistics Socio-economic
107
Classification [25]. The groups were divided according to occupation as follows: 1. Self-employed, chief executive
108
directors, employees whose work requires skills of the highest educational level. 2. Employees whose work requires
109
skills of a medium long educational level. 3. Trained workers and employees whose work requires skills of a short
110
educational level. 4. Untrained workers, temporary unemployed, and students. 5. People outside the workforce (e.g.
111
senior citizens and disability pensioners). Groups were re-categorized into 1-2: high SES and 3-5: low-medium SES.
112
To ensure reliable data collection, the clinic’s staff members received one-day training in the use of the TCOCT
113
protocol during a study visit at The Children’s Obesity Clinic, Department of Pediatrics, Holbæk University Hospital.
114
Thereafter, all nurses, dieticians, and pediatricians starting in the clinic received training and supervision from more
115
experienced colleagues.
116 117
Treatment Intervention
118
A trusting relationship between the family and the health care personnel was sought established through a structured
119
pedagogical conversation. This strategy sought to optimise diagnosis, treatment, and follow-up of patients and to
120
provide the patient and his/her family with a set of tools in order to implement the needed lifestyle changes. The
121
pediatrician defined a structured and individually tailored treatment plan for the patient in collaboration with the
122
family. The treatment plan was based on the lifestyle history as well as the patient and his/her family’s daily routines
123
such as school and work hours, place of residence, and spare time activities. Any additional underlying disease to
5
124
obesity, e.g. Prader-Willi syndrome, was integrated in the treatment plan. The plan was delivered in hard copy to
125
support the necessary lifestyle and behavioral changes and to help the patient and his/her family to control the
126
environment. The treatment plan structure offers potentially more than ninety items of advices [17], but individual
127
treatment plans typically contained 15-20 advices at the baseline visit. After the follow-up visits (see below), patients
128
were seen annually by a pediatrician (30 min) to monitor the treatment response and address any necessary
129
adjustments in the treatment plan.
130
Follow-up visits (45 min) with a trained pediatric nurse were offered in intervals of 8-10 weeks. The follow-up
131
intervals were individualised to the family’s needs and resources (i.e. depending on the patient’s treatment
132
progression, and on practical limitations). Patients were followed by the same nurse to maintain a secure environment
133
for the patient. Regardless of treatment response, families were supported when they showed up at appointments and
134
were reinforced on advices that were integrated in their daily lives. Lack of adherence to intervention advices were
135
specifically identified and discussed and re-implemented, so the treatment plan was revised accordingly. In treatment,
136
all patients were offered one visit (45 min) with a dietician. The dietician would monitor the treatment progression
137
and further specify or modify the diet for the patient. If the family lacked considerable knowledge regarding dieting,
138
food, and cooking, the dietician would offer a second consultation (45 min). Height and weight were measured at all
139
visits by nurses, dieticians, or pediatricians.
140
Patients were discharged if they missed more than three scheduled appointments and were then categorised as
141
dropouts. Clinical success and hence discharge were decided by the pediatrician using the following criteria: If the
142
patient and the family’s understanding and adherence of the treatment plan were satisfactory and if the patient’s BMI
143
had decreased or stabilised, success was ascertained. The patients were followed until clinical success was achieved,
144
the patients dropped out, the patients moved away, or the patients reached their 25th birthday.
145 146
Statistical methods
147
All measurements were entered into a Microsoft Access database and exported to Statistical Analysis Software (SAS)
148
for the analyses. Body mass index standard deviation scores (BMI SDS) were determined based on the distribution of
149
a Danish population with the same sex and age [22], using the LMS method. BMI of parents was calculated as weight
6
150
divided by height squared. The levels of baseline BMI SDS in different groups of patients were compared using
151
ANOVA. The longitudinal development of BMI SDS during treatment was modeled using a generalised linear mixed
152
model. The covariance structure includes a random intercept, allowing each child to have his/her own overall level of
153
BMI SDS, and an exponential residual structure, allowing the covariance between two measurements on the same
154
child to decrease as the time between measurements increases. The mean value of BMI SDS was modeled as a
155
function of time since initiation of treatment, using a cubic spline with three a priori -chosen knots (at 2, 11, and 33
156
months, respectively). The associations between change in obesity and baseline characteristics were assessed by
157
performing a test for interaction between a dichotomised version of the baseline characteristic and time since
158
treatment initiation in the generalised linear mixed model. The degree of retention was illustrated by a Kaplan-Meier
159
plot and by calculating the equivalent retention rates after one and two years. Associations between baseline
160
characteristics and retention were analysed with a cox regression analysis. P-values below 0.05 were considered
161
statistically significant.
162 163
Ethical considerations
164
This study has been approved by the Danish Data Protection Agency; journal number: 2007-58-0015. All participants
165
gave written consent to participate in treatment. The study is considered as a prospective observational quality
166
development study. Therefore notification to the National Committee on Health Research Ethics or to the National
167
Board of Health was not required [26, 27]. All patients received state-funded treatment, as permanent residents in
168
Denmark can use the Danish healthcare system free of charge.
169 170
Results
171
In the period of February 2010 to March 2013 313 patients (141 boys) were included. Baseline characteristics of
172
patients are shown in Table I. Table II shows the various co-morbidities encountered among the obese patients.
173
At baseline, mean BMI SDS was significantly higher in boys than in girls (boys mean BMI SDS 3.23, range 1.31 –
174
6.31, girls mean BMI 2.82, range 1.40 – 4.33, difference 0.41 SDS (95% CI: 0.25; 0.57, p < 0.0001)). Mean baseline
175
BMI SDS was positively associated with parental BMI: Patients with two overweight parents, or just one obese
7
176
parent, had a mean of 0.45 (95% CI: 0.25; 0.65, p < 0.0001) BMI SDS higher than patients with just one or no
177
overweight parents. Patients who had parents with low to medium socioeconomic status had a mean 0.35 (95% CI:
178
0.19; 0.52, p < 0.0001) BMI SDS higher than patients whose parents a high socioeconomic status. Patients referred
179
from general practitioners and school- and community based doctors had a mean 0.20 (95% CI: 0.02; 0.38, p = 0.03)
180
BMI SDS higher than patients referred from the departments of pediatrics. Baseline BMI SDS was significantly
181
associated with puberty in boys, with prepubertal boys having on average 0.55 (95% CI: 0.24; 0.86, p = 0.0007) BMI
182
SDS higher than boys who had entered puberty. This association was not found in girls (p = 0.10). Baseline BMI SDS
183
was independent of age (p = 0.26), family structure (p = 0.46), and co-morbidity (p = 0.81). Median BMI SDS in
184
parents (N=546) was 28 (range 17.6-53.3), in mothers (N=272) 27.7 (17.6-53.3) and in fathers (N=271) 28.4 (18.9-
185
53). In total BMI SDS was