NCT00928473

Brief Summary

The Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. The biobank thus facilitates translation between research and clinical practice of obesity treatment and related complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
16.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

16.9 years

First QC Date

June 25, 2009

Last Update Submit

November 9, 2020

Conditions

ObesityMetabolic DiseaseNAFLD, Non-alcoholic Fatty Liver DiseaseCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Weightloss, changes in blood parameters and in fatty liver developement.

    continuously

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.

Behavioral: A family-centered, multidisciplinary obesity treatment program

Interventions

A family-centered, multidisciplinary obesity treatment programBEHAVIORAL

The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.

Also known as: (Holm, J. C. et al. Chronic care treatment of obese children and adolescents. Int. J. Pediatr. Obes. 6, 188-196, 2011).
Lifestyle counseling

Eligibility Criteria

Age2 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Years old
  • Adipose, BMI \> 90 % percentile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Obesity Clinic, Paediatric department, University Hospital Holbæk, Region Zealand

Holbæk, 4300, Denmark

RECRUITING

Related Publications (22)

  • Stinson SE, Jonsson AE, Andersen MK, Lund MAV, Holm LA, Fonvig CE, Huang Y, Stankevic E, Juel HB, Angquist L, Sorensen TIA, Ongstad EL, Gaddipati R, Grimsby J, Rhodes CJ, Pedersen O, Christiansen M, Holm JC, Hansen T. High Plasma Levels of Soluble Lectin-like Oxidized Low-Density Lipoprotein Receptor-1 Are Associated With Inflammation and Cardiometabolic Risk Profiles in Pediatric Overweight and Obesity. J Am Heart Assoc. 2023 Feb 7;12(3):e8145. doi: 10.1161/JAHA.122.027042. Epub 2023 Jan 25.

    PMID: 36695299DERIVED

  • Johansen MJ, Vonsild Lund MA, Angquist L, Fonvig CE, Holm LA, Chabanova E, Thomsen HS, Hansen T, Holm JC. Possible prediction of obesity-related liver disease in children and adolescents using indices of body composition. Pediatr Obes. 2022 Oct;17(10):e12947. doi: 10.1111/ijpo.12947. Epub 2022 Jun 21.

    PMID: 35726748DERIVED

  • Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Fonvig CE, Lankjaer IOJ, Hansen T, Hansen T, Baker JL, Holm JC. Early detection of childhood overweight and related complications in a Danish population-based cohort aged 2-8 years. Obes Res Clin Pract. 2022 May-Jun;16(3):228-234. doi: 10.1016/j.orcp.2022.04.001. Epub 2022 May 3.

    PMID: 35514021DERIVED

  • Stinson SE, Jonsson AE, de Retana Alzola IF, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Fonvig CE, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Hyperglucagonemia in Pediatric Adiposity Associates With Cardiometabolic Risk Factors but Not Hyperglycemia. J Clin Endocrinol Metab. 2022 May 17;107(6):1569-1576. doi: 10.1210/clinem/dgac108.

    PMID: 35213713DERIVED

  • Stinson SE, Jonsson AE, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents. J Clin Endocrinol Metab. 2021 May 13;106(6):1718-1727. doi: 10.1210/clinem/dgab098.

    PMID: 33596309DERIVED

  • Lund MAV, Thostrup AH, Frithioff-Bojsoe C, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Hansen T, Holm JC. Low-grade inflammation independently associates with cardiometabolic risk in children with overweight/obesity. Nutr Metab Cardiovasc Dis. 2020 Aug 28;30(9):1544-1553. doi: 10.1016/j.numecd.2020.04.024. Epub 2020 May 5.

    PMID: 32571613DERIVED

  • Jors A, Lund MAV, Jespersen T, Hansen T, Poulsen HE, Holm JC. Urinary markers of nucleic acid oxidation increase with age, obesity and insulin resistance in Danish children and adolescents. Free Radic Biol Med. 2020 Aug 1;155:81-86. doi: 10.1016/j.freeradbiomed.2020.05.009. Epub 2020 May 25.

    PMID: 32464183DERIVED

  • Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Baker JL, Hansen T, Holm JC. Leptin, adiponectin, and their ratio as markers of insulin resistance and cardiometabolic risk in childhood obesity. Pediatr Diabetes. 2020 Mar;21(2):194-202. doi: 10.1111/pedi.12964. Epub 2019 Dec 26.

    PMID: 31845423DERIVED

  • Johansen MJ, Gade J, Stender S, Frithioff-Bojsoe C, Lund MAV, Chabanova E, Thomsen HS, Pedersen O, Fonvig CE, Hansen T, Holm JC. The Effect of Overweight and Obesity on Liver Biochemical Markers in Children and Adolescents. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz010. doi: 10.1210/clinem/dgz010.

    PMID: 31617910DERIVED

  • Viitasalo A, Schnurr TM, Pitkanen N, Hollensted M, Nielsen TRH, Pahkala K, Atalay M, Lind MV, Heikkinen S, Frithioff-Bojsoe C, Fonvig CE, Grarup N, Kahonen M, Carrasquilla GD, Larnkjaer A, Pedersen O, Michaelsen KF, Lakka TA, Holm JC, Lehtimaki T, Raitakari O, Hansen T, Kilpelainen TO. Abdominal adiposity and cardiometabolic risk factors in children and adolescents: a Mendelian randomization analysis. Am J Clin Nutr. 2019 Nov 1;110(5):1079-1087. doi: 10.1093/ajcn/nqz187.

    PMID: 31504107DERIVED

  • Hollensted M, Fogh M, Schnurr TM, Kloppenborg JT, Have CT, Ruest Haarmark Nielsen T, Rask J, Asp Vonsild Lund M, Frithioff-Bojsoe C, Ostergaard Johansen M, Vincent Rosenbaum Appel E, Mahendran Y, Grarup N, Kadarmideen HN, Pedersen O, Holm JC, Hansen T. Genetic Susceptibility for Childhood BMI has no Impact on Weight Loss Following Lifestyle Intervention in Danish Children. Obesity (Silver Spring). 2018 Dec;26(12):1915-1922. doi: 10.1002/oby.22308.

    PMID: 30460774DERIVED

  • Fonvig CE, Hamann SA, Nielsen TRH, Johansen MO, Gronbaek HN, Mollerup PM, Holm JC. Subjective evaluation of psychosocial well-being in children and youths with overweight or obesity: the impact of multidisciplinary obesity treatment. Qual Life Res. 2017 Dec;26(12):3279-3288. doi: 10.1007/s11136-017-1667-5. Epub 2017 Jul 31.

    PMID: 28762099DERIVED

  • Nielsen TRH, Lausten-Thomsen U, Fonvig CE, Bojsoe C, Pedersen L, Bratholm PS, Hansen T, Pedersen O, Holm JC. Dyslipidemia and reference values for fasting plasma lipid concentrations in Danish/North-European White children and adolescents. BMC Pediatr. 2017 Apr 28;17(1):116. doi: 10.1186/s12887-017-0868-y.

    PMID: 28454530DERIVED

  • Rischel HE, Nielsen LA, Gamborg M, Moller P, Holm JC. Comparison of sensory-specific satiety between normal weight and overweight children. Appetite. 2016 Dec 1;107:486-493. doi: 10.1016/j.appet.2016.08.123. Epub 2016 Sep 1.

    PMID: 27593452DERIVED

  • Trier C, Dahl M, Stjernholm T, Nielsen TR, Bojsoe C, Fonvig CE, Pedersen O, Hansen T, Holm JC. Effects of a Family-Based Childhood Obesity Treatment Program on Parental Weight Status. PLoS One. 2016 Aug 25;11(8):e0161921. doi: 10.1371/journal.pone.0161921. eCollection 2016.

    PMID: 27560141DERIVED

  • Fonvig CE, Chabanova E, Ohrt JD, Nielsen LA, Pedersen O, Hansen T, Thomsen HS, Holm JC. Multidisciplinary care of obese children and adolescents for one year reduces ectopic fat content in liver and skeletal muscle. BMC Pediatr. 2015 Dec 30;15:196. doi: 10.1186/s12887-015-0513-6.

    PMID: 26714769DERIVED

  • Lausten-Thomsen U, Christiansen M, Fonvig CE, Trier C, Pedersen O, Hansen T, Holm JC. Reference values for serum total adiponectin in healthy non-obese children and adolescents. Clin Chim Acta. 2015 Oct 23;450:11-4. doi: 10.1016/j.cca.2015.07.012. Epub 2015 Jul 10.

    PMID: 26169157DERIVED

  • Hvidt KN, Olsen MH, Ibsen H, Holm JC. Weight reduction and aortic stiffness in obese children and adolescents: a 1-year follow-up study. J Hum Hypertens. 2015 Sep;29(9):535-40. doi: 10.1038/jhh.2014.127. Epub 2015 Jan 15.

    PMID: 25589213DERIVED

  • Hvidt KN, Olsen MH, Ibsen H, Holm JC. Effect of changes in BMI and waist circumference on ambulatory blood pressure in obese children and adolescents. J Hypertens. 2014 Jul;32(7):1470-7; discussion 1477. doi: 10.1097/HJH.0000000000000188.

    PMID: 24733029DERIVED

  • Hvidt KN, Olsen MH, Holm JC, Ibsen H. Obese children and adolescents have elevated nighttime blood pressure independent of insulin resistance and arterial stiffness. Am J Hypertens. 2014 Nov;27(11):1408-15. doi: 10.1093/ajh/hpu055. Epub 2014 Apr 9.

    PMID: 24717420DERIVED

  • Lausten-Thomsen U, Nielsen TR, Thagaard IN, Larsen T, Holm JC. Neonatal anthropometrics and body composition in obese children investigated by dual energy X-ray absorptiometry. Eur J Pediatr. 2014 May;173(5):623-7. doi: 10.1007/s00431-013-2226-x. Epub 2013 Dec 7.

    PMID: 24318487DERIVED

  • 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: 22157326DERIVED

MeSH Terms

Conditions

ObesityMetabolic DiseasesNon-alcoholic Fatty Liver DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Jens-Christian Holm, Ph.d., MD

    The Children's Obesity Clinic and The Danish Childhood Obesity Biobank

    STUDY CHAIR

Central Study Contacts

Jens-Christian Holm, Ph.d., MD

CONTACT

jhom@regionsjaelland.dk

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, PhD

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

DK(1)