Cost-effectiveness of intensive inpatient treatments for severely obese children and adolescents in the Netherlands; a randomised controlled trial (HELIOS).

BACKGROUND: Intensive combined lifestyle interventions are the recommended treatment for severely obese children and adolescents, but there is a lack of studies and their cost-effectiveness. The objective of this study is to compare the cost-effectiveness of two intensive one-year inpatient treatments and usual care for severely obese children and adolescents. METHODS/DESIGN: Participants are 40 children aged 8-13 and 40 adolescents aged 13-18 with severe obesity (SDS-BMI ≥ 3.0 or SDS-BMI ≥ 2.3 with obesity related co-morbidity). They will be randomized into two groups that will receive a comprehensive treatment program of 12 months that focuses on nutrition, physical activity and behavior change of the participant and their parents. The two programs are the same in total duration (12 months), but differ in inpatient treatment duration. Group A will participate in a 6 month intensive inpatient treatment program during weekdays, followed by six monthly return visits of 2 days. Group B will participate in a 2 month intensive inpatient treatment program during weekdays, followed by biweekly return visits of 2 days during the next four months, followed by six monthly return visits of 2 days. Several different health care professionals are involved, such as pediatricians, dieticians, psychologists, social workers, nurses and physiotherapists. Results will also be compared to a control group that receives usual care. The primary outcome is SDS-BMI. Secondary outcomes include quality of life using the EQ-5D and cardiovascular risk factors. Data will be collected at baseline and after 6, 12 and 24 months. An economic evaluation will be conducted alongside this study. Healthcare consumption will be based on actual resource use, using prospective data collection during 2 years through cost diaries. Quality Adjusted Life Years (QALYs) will be calculated using the EQ-5D. DISCUSSION: This study will provide useful information on the effectiveness and cost-effectiveness of inpatient treatment in severely obese children and adolescents. Valuable information on long term effects, after 2 years, is also included. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1678

Cardiometabolic risk factors and quality of life in severely obese children and adolescents in the Netherlands

BACKGROUND: The prevalence of severe obesity in children and adolescents is increasing. However, little is known about cardiometabolic risk factors and quality of life of children with severe obesity.Therefore, the aim of this study was to assess the demographic characteristics and the prevalence of cardiometabolic risk factors and quality of life in severely obese children and adolescents undergoing intensive inpatient treatment for obesity. METHODS: Data were collected between August 2009 and April 2011 on 16 children (8-13y) and 64 adolescents (13-19y) with severe obesity (SDS-BMI >= 3.0 or SDS-BMI >= 2.3 and comorbidity) participating in an RCT evaluating two intensive inpatient treatment programs for obesity. Demographic, anthropometric, clinical characteristics and two components of the EuroQol for the assessment of quality of life are described. RESULTS: Eighty percent of participants in this study had at least one cardiometabolic risk factor in addition to severe obesity. Low HDL-cholesterol and hypertension were most prevalent (65.0% respectively 31.2%). The highest significant correlations were found between SDS-BMI and SDS-waist circumference, fasting plasma insulin and HOMA-IR (correlation coefficients respectively 0.80, 0.49, and 0.48). With regard to quality of life, the mean utility score of the participants was 0.79 on a scale of 0.0 to 1.0 on the EuroQol questionnaire and their mean individual valuation was 69.1 on a scale of 0 to100. CONCLUSION: Cardiometabolic risk factors are already highly prevalent in this group of severely obese children and adolescents. The score of 69.1 found for quality of life in this study suggests that participants experience important limitations in their quality of life. However, quality of life is not associated with the prevalence of cardiometabolic risk factors. TRIAL REGISTRATION: Netherlands Trial Register (NTR1678, registered 20-Feb-2009)

Cost-effectiveness of intensive inpatient treatments for severely obese children and adolescents in the Netherlands; a randomized controlled trial (HELIOS)

Abstract Background Intensive combined lifestyle interventions are the recommended treatment for severely obese children and adolescents, but there is a lack of studies and their cost-effectiveness. The objective of this study is to compare the cost-effectiveness of two intensive one-year inpatient treatments and usual care for severely obese children and adolescents. Methods/Design Participants are 40 children aged 8-13 and 40 adolescents aged 13-18 with severe obesity (SDS-BMI ≥ 3.0 or SDS-BMI ≥ 2.3 with obesity related co-morbidity). They will be randomized into two groups that will receive a comprehensive treatment program of 12 months that focuses on nutrition, physical activity and behavior change of the participant and their parents. The two programs are the same in total duration (12 months), but differ in inpatient treatment duration. Group A will participate in a 6 month intensive inpatient treatment program during weekdays, followed by six monthly return visits of 2 days. Group B will participate in a 2 month intensive inpatient treatment program during weekdays, followed by biweekly return visits of 2 days during the next four months, followed by six monthly return visits of 2 days. Several different health care professionals are involved, such as pediatricians, dieticians, psychologists, social workers, nurses and physiotherapists. Results will also be compared to a control group that receives usual care. The primary outcome is SDS-BMI. Secondary outcomes include quality of life using the EQ-5D and cardiovascular risk factors. Data will be collected at baseline and after 6, 12 and 24 months. An economic evaluation will be conducted alongside this study. Healthcare consumption will be based on actual resource use, using prospective data collection during 2 years through cost diaries. Quality Adjusted Life Years (QALYs) will be calculated using the EQ-5D. Discussion This study will provide useful information on the effectiveness and cost-effectiveness of inpatient treatment in severely obese children and adolescents. Valuable information on long term effects, after 2 years, is also included. Trial registration Netherlands Trial Register (NTR): NTR1678</p

One-year effects of two intensive inpatient treatments for severely obese children and adolescents

BACKGROUND: Intensive inpatient lifestyle treatment may be a suitable alternative for severely obese children and adolescents who do not benefit from ambulatory obesity treatment. The aim was to evaluate the effectiveness of two intensive one-year lifestyle treatments with varying inpatient periods for severely obese children and adolescents with regard to SDS-BMI and cardiometabolic risk factors. METHODS: The study was designed as a randomized controlled trial with two active treatment groups. Eighty participants (8-19 years) with severe obesity received treatment at a specialized childhood obesity center in the Netherlands. Severe obesity was defined as a SDS-BMI ≥ 3.0 or a SDS-BMI ≥ 2.3 in combination with obesity-related comorbidity. Participants received an intensive one-year lifestyle treatment with an inpatient period of either two months and biweekly return visits during the next four months (short-stay group) or six months (long-stay group), both followed by six monthly return visits. Outcomes were assessed at baseline, six and 12 months and included SDS-BMI as primary outcome and cardiometabolic risk factors such as SDS-waist circumference, systolic- and diastolic blood pressure, and blood measurements as secondary outcomes. To evaluate differences in the course of the primary- and secondary outcomes over time between the two treatment groups, Generalized Estimating Equations (GEE) were performed. RESULTS: No differences in the course of SDS-BMI or secondary outcomes over time were found between the two treatment groups after one year of treatment. SDS-BMI decreased statistically significantly after one year of treatment compared with baseline in both groups (0.33 (0.48) in the short-stay and 0.52 (0.49) in the long-stay group). Similar results were found for SDS-waist circumference, diastolic blood pressure and HDL-cholesterol. CONCLUSIONS: Since there were no significant differences in effects between the short- and long-stay treatment and considering the burden of the long-stay treatment for children and families, we recommend implementation of the short-stay treatment. TRIAL REGISTRATION: Netherlands Trial Register NTR1678 , registered 20-Feb-2009

Economic Evaluation of Intensive Inpatient Treatments for Severely Obese Children and Adolescents

Background: Considering the large economic consequences of severe childhood obesity for the society, we aimed to conduct an economic evaluation comparing two intensive 1-year lifestyle treatments with varying inpatient periods for severely obese children and adolescents with regard to standard deviation score BMI (SDS-BMI) and quality-adjusted life years (QALYs). Methods: An economic evaluation from a societal perspective accompanying a randomized controlled trial with a 24-month follow-up. 80 participants (8-19 years) with severe obesity were included. Participants received an intensive 1-year lifestyle treatment with an inpatient period of 2 months (short-stay group) or 6 months (long-stay group). Data were collected at baseline, 6, 12 ,and 24 months and included SDS-BMI and QALYs. Results: SDS-BMI decreased in the first 6 months of treatment, stabilized in the second 6 months, and increased during the 2nd year in both groups. After 24 months, SDS-BMI was similar in both groups, but remained lower than baseline values (mean difference -0.24, 95% CI -0.42; -0.06). There was no difference in QALYs between the groups after 24 months. For SDS-BMI, the probability of the short-stay treatment being cost-effective in comparison with the long-stay treatment was 1 at a willingness-to-pay of 0 EUR/unit of effect, which slowly decreased to 0.54 for larger willingness-to-pay values. Conclusions: Based on the results of this study, the short-stay treatment is considered to be more cost-effective from the societal perspective in comparison with the long-stay treatment. Future research should provide insight in whether the short-stay treatment is cost-effective in comparison with usual care

Health-related quality of life in children and adolescents with severe obesity after intensive lifestyle treatment and at 1-year follow-up

Objective: To examine changes in generic and weight-related, health-related quality of life (HRQoL) in children and adolescents with severe obesity participating in intensive lifestyle treatment, and to examine whether changes in SDS-BMI were associated with changes in HRQoL. Methods: In this prospective observational study, a referred sample of 120 children and adolescents (8-19 years) with severe obesity (SDS-BMI ≥ 3.0, or ≥ 2.3 in combination with obesity-related comorbidity) received an intensive 1-year lifestyle treatment with an inpatient period in a specialized childhood obesity center. A weight-related (IWQOL-Kids) and three generic (KIDSCREEN-52, PedsQL 4.0, and EuroQol) HRQoL questionnaires were administered at baseline (T0), after treatment (T1), and 1 year later (T2). Generalized Linear Mixed Models and partial correlations were used to analyze changes in HRQoL and associations with changes in SDS-BMI. Results: Statistically significant improvements in generic and weight-related HRQoL overall and domain scores were observed at T1and at T2 in comparison with T0, despite partial weight regain from T1 to T2. Larger weight loss at T2 was correlated with larger improvements in physical HRQoL domains. Conclusion: Children and adolescents with severe obesity experienced long-term improvements in generic and weight-related HRQoL after participating in intensive lifestyle treatment, despite partial weight regain