NCT02013843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,007

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

December 6, 2013

Last Update Submit

March 28, 2016

Conditions

Pediatric ObesityDyslipidemiaHypertensionDiabetesQuality of Life

Keywords

Pediatric obesityCommunity-based treatmentdyslipidemiahypertensiondiabetes

Outcome Measures

Primary Outcomes (1)

  • Body mass index standard deviation score

    primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity.

    1 year

Secondary Outcomes (5)

  • Change in blood pressure standard deviation score

    1 year

  • Change in the concentration of blood lipids

    1 year

  • change in the concentration of fasting blood-glucose, HBA1C and insulin

    1 year

  • Change in body composition measured by Tanita BC 418

    1 year

  • Change in quality of life assessed by PedsQL

    1 year

Other Outcomes (1)

  • cost effectiveness

    1 year

Study Arms (1)

Community-based treatment

OTHER

Overweight and obese children are seen on a regular basis by health care professionals in the 8 communities included in the project. The care providers are all trained thoroughly in using the "Holbaek-method" for treatment of pediatric obesity.

Behavioral: Community-based treatment of overweight and obesity

Interventions

Community-based treatment of overweight and obesityBEHAVIORAL

Community based treatment of overweight and obese children using the "Holbaek-method".

Community-based treatment

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric department

Holbæk, 4300, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 22157326BACKGROUND

  • 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.

    PMID: 21529264BACKGROUND

  • 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.

    PMID: 28213684DERIVED

MeSH Terms

Conditions

Pediatric ObesityDyslipidemiasHypertensionDiabetes Mellitus

Interventions

Adiposity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 17, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

DK(1)