Adoption of The Children s Obesity Clinic s Treatment (TCOCT) Protocol. into another Danish Pediatric Obesity Treatment Clinic

Adoption of The Children’s Obesity Clinic’s Treatment (TCOCT) Protocol into another Danish Pediatric Obesity Treatment Clinic 1 Running title: Childh...
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Adoption of The Children’s Obesity Clinic’s Treatment (TCOCT) Protocol into another Danish Pediatric Obesity Treatment Clinic 1

Running title: Childhood Obesity Treatment

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SEBASTIAN W. MOST1, BIRGITTE HØJGAARD1, GRETE TEILMANN1,4, JESPER ANDERSEN1,4, METTE

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VALENTINER1, MICHAEL GAMBORG2 & JENS-CHRISTIAN HOLM3,4

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Hillerød, Denmark SWM: [email protected] GT: [email protected] JA:

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[email protected] MV: [email protected] BH: [email protected]

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The Children’s Obesity Clinic, Department of Pediatrics, Nordsjællands Hospital, Hillerød, Copenhagen University,

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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

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Corresponding author:

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Sebastian Wenzel Most, stud.med.

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Department of Pediatrics, Nordsjællands Hospital, Hillerød

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Dyrehavevej 29, DK-3400 Hillerød, Denmark

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Phone: +45 27 21 07 60 e-mail: [email protected]

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Abstract

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Background. Treating severe childhood obesity has proven difficult with inconsistent treatment results. This study

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reports the results of the implementation of a childhood obesity chronic care treatment protocol.

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Methods. Patients aged 5 to 18 years with a body mass index (BMI) above the 99th percentile for sex and age were

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eligible for inclusion. At baseline patients’ height, weight, and tanner stages were measured, as well as parents’

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socioeconomic status (SES) and family structure. Parental weight and height were self-reported. An individualised

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treatment plan including numerous advices was developed in collaboration with the patient and the family. Patients’

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height and weight were measured at subsequent visits. There were no exclusion criteria.

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Results. Three-hundred-thirteen (141 boys) were seen in the clinic in the period of February 2010 to March 2013. At

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inclusion, the median age of patients was 11.1 years and the median BMI standard deviation score (SDS) was 3.24 in

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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


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BMI < 30), or being obese (BMI > 30) according to WHO guidelines [24]. Family structure was classified as follows,

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by whom the patient was living with: (a) both parents, (b) disrupted family (i.e. single or divorced parents with or

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without stepfamily), or (c) alternative family structures such as foster families, group homes, or with other family

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members. The investigation and interview form is available from the authors.

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Socioeconomic status (SES) was defined in groups of 1 – 5 based on the National Statistics Socio-economic

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Classification [25]. The groups were divided according to occupation as follows: 1. Self-employed, chief executive

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directors, employees whose work requires skills of the highest educational level. 2. Employees whose work requires

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skills of a medium long educational level. 3. Trained workers and employees whose work requires skills of a short

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educational level. 4. Untrained workers, temporary unemployed, and students. 5. People outside the workforce (e.g.

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senior citizens and disability pensioners). Groups were re-categorized into 1-2: high SES and 3-5: low-medium SES.

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To ensure reliable data collection, the clinic’s staff members received one-day training in the use of the TCOCT

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protocol during a study visit at The Children’s Obesity Clinic, Department of Pediatrics, Holbæk University Hospital.

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Thereafter, all nurses, dieticians, and pediatricians starting in the clinic received training and supervision from more

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experienced colleagues.

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Treatment Intervention

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A trusting relationship between the family and the health care personnel was sought established through a structured

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pedagogical conversation. This strategy sought to optimise diagnosis, treatment, and follow-up of patients and to

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provide the patient and his/her family with a set of tools in order to implement the needed lifestyle changes. The

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pediatrician defined a structured and individually tailored treatment plan for the patient in collaboration with the

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family. The treatment plan was based on the lifestyle history as well as the patient and his/her family’s daily routines

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such as school and work hours, place of residence, and spare time activities. Any additional underlying disease to

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obesity, e.g. Prader-Willi syndrome, was integrated in the treatment plan. The plan was delivered in hard copy to

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support the necessary lifestyle and behavioral changes and to help the patient and his/her family to control the

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environment. The treatment plan structure offers potentially more than ninety items of advices [17], but individual

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treatment plans typically contained 15-20 advices at the baseline visit. After the follow-up visits (see below), patients

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were seen annually by a pediatrician (30 min) to monitor the treatment response and address any necessary

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adjustments in the treatment plan.

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Follow-up visits (45 min) with a trained pediatric nurse were offered in intervals of 8-10 weeks. The follow-up

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intervals were individualised to the family’s needs and resources (i.e. depending on the patient’s treatment

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progression, and on practical limitations). Patients were followed by the same nurse to maintain a secure environment

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for the patient. Regardless of treatment response, families were supported when they showed up at appointments and

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were reinforced on advices that were integrated in their daily lives. Lack of adherence to intervention advices were

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specifically identified and discussed and re-implemented, so the treatment plan was revised accordingly. In treatment,

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all patients were offered one visit (45 min) with a dietician. The dietician would monitor the treatment progression

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and further specify or modify the diet for the patient. If the family lacked considerable knowledge regarding dieting,

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food, and cooking, the dietician would offer a second consultation (45 min). Height and weight were measured at all

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visits by nurses, dieticians, or pediatricians.

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Patients were discharged if they missed more than three scheduled appointments and were then categorised as

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dropouts. Clinical success and hence discharge were decided by the pediatrician using the following criteria: If the

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patient and the family’s understanding and adherence of the treatment plan were satisfactory and if the patient’s BMI

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had decreased or stabilised, success was ascertained. The patients were followed until clinical success was achieved,

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the patients dropped out, the patients moved away, or the patients reached their 25th birthday.

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Statistical methods

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All measurements were entered into a Microsoft Access database and exported to Statistical Analysis Software (SAS)

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for the analyses. Body mass index standard deviation scores (BMI SDS) were determined based on the distribution of

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a Danish population with the same sex and age [22], using the LMS method. BMI of parents was calculated as weight

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divided by height squared. The levels of baseline BMI SDS in different groups of patients were compared using

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ANOVA. The longitudinal development of BMI SDS during treatment was modeled using a generalised linear mixed

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model. The covariance structure includes a random intercept, allowing each child to have his/her own overall level of

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BMI SDS, and an exponential residual structure, allowing the covariance between two measurements on the same

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child to decrease as the time between measurements increases. The mean value of BMI SDS was modeled as a

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function of time since initiation of treatment, using a cubic spline with three a priori -chosen knots (at 2, 11, and 33

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months, respectively). The associations between change in obesity and baseline characteristics were assessed by

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performing a test for interaction between a dichotomised version of the baseline characteristic and time since

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treatment initiation in the generalised linear mixed model. The degree of retention was illustrated by a Kaplan-Meier

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plot and by calculating the equivalent retention rates after one and two years. Associations between baseline

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characteristics and retention were analysed with a cox regression analysis. P-values below 0.05 were considered

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statistically significant.

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Ethical considerations

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This study has been approved by the Danish Data Protection Agency; journal number: 2007-58-0015. All participants

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gave written consent to participate in treatment. The study is considered as a prospective observational quality

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development study. Therefore notification to the National Committee on Health Research Ethics or to the National

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Board of Health was not required [26, 27]. All patients received state-funded treatment, as permanent residents in

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Denmark can use the Danish healthcare system free of charge.

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Results

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In the period of February 2010 to March 2013 313 patients (141 boys) were included. Baseline characteristics of

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patients are shown in Table I. Table II shows the various co-morbidities encountered among the obese patients.

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At baseline, mean BMI SDS was significantly higher in boys than in girls (boys mean BMI SDS 3.23, range 1.31 –

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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

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BMI SDS was positively associated with parental BMI: Patients with two overweight parents, or just one obese

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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

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overweight parents. Patients who had parents with low to medium socioeconomic status had a mean 0.35 (95% CI:

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0.19; 0.52, p < 0.0001) BMI SDS higher than patients whose parents a high socioeconomic status. Patients referred

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from general practitioners and school- and community based doctors had a mean 0.20 (95% CI: 0.02; 0.38, p = 0.03)

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BMI SDS higher than patients referred from the departments of pediatrics. Baseline BMI SDS was significantly

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associated with puberty in boys, with prepubertal boys having on average 0.55 (95% CI: 0.24; 0.86, p = 0.0007) BMI

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SDS higher than boys who had entered puberty. This association was not found in girls (p = 0.10). Baseline BMI SDS

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was independent of age (p = 0.26), family structure (p = 0.46), and co-morbidity (p = 0.81). Median BMI SDS in

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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-

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53). In total BMI SDS was

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