Clinical trial NCT02013843: Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.
Official title: Treatment of Overweight and Obese Children - the "Holbaek-Method" in a Municipality Based Treatment Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Dyslipidemia
Hypertension
Diabetes
Quality of Life
Keywords: Pediatric obesity
Community-based treatment
dyslipidemia
hypertension
diabetes
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2013-12-17
Enrollment: 1007
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life and concentration of fasting blood lipids and glucose during one year of treatment.

Detailed description: In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek and the care providers in each of the eight municipalities included are thought thoroughly to use this method.

The treatment effect is evaluated after one year, and the effect is assessed by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life (PedsQL), body composition and concentration of fasting blood lipids and glucose.

Eligibility criteria: Inclusion Criteria:

- Body mass index above 90-percentile for age and gender

Exclusion Criteria:

* None

Primary outcomes:
measure: Body mass index standard deviation score
timeFrame: 1 year
Secondary outcomes:
measure: Change in blood pressure standard deviation score
timeFrame: 1 year
measure: Change in the concentration of blood lipids
timeFrame: 1 year
measure: change in the concentration of fasting blood-glucose, HBA1C and insulin
timeFrame: 1 year
measure: Change in body composition measured by Tanita BC 418
timeFrame: 1 year
measure: Change in quality of life assessed by PedsQL
timeFrame: 1 year
Other outcomes:
measure: cost effectiveness
timeFrame: 1 year
Locations:
city: Holbaek
country: Denmark
facility: Pediatric department
Study officials:
References:
citation: Holm JC, Gamborg M, Neland M, Ward L, Gammeltoft S, Heitmann BL, Sorensen TI, Ibsen KK. Longitudinal changes in blood pressure during weight loss and regain of weight in obese boys and girls. J Hypertens. 2012 Feb;30(2):368-74. doi: 10.1097/HJH.0b013e32834e4a87.
citation: Holm JC, Gamborg M, Bille DS, Gr Nb K HN, Ward LC, Faerk J. Chronic care treatment of obese children and adolescents. Int J Pediatr Obes. 2011 Aug;6(3-4):188-96. doi: 10.3109/17477166.2011.575157. Epub 2011 May 2.
citation: Mollerup PM, Nielsen TRH, Bojsoe C, Kloppenborg JT, Baker JL, Holm JC. Quality of life improves in children and adolescents during a community-based overweight and obesity treatment. Qual Life Res. 2017 Jun;26(6):1597-1608. doi: 10.1007/s11136-017-1504-x. Epub 2017 Feb 17.