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NCT Number: NCT02013843

Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.

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.

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Key information

Conditions

Pediatric Obesity Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Vascular Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric department

Holbæk, 4300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Community-based treatment of overweight and obesity

Behavioral

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

Primary outcomes

  1. Body mass index standard deviation score

    Time frame: 1 year

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

Secondary outcomes

  1. Change in blood pressure standard deviation score

    Time frame: 1 year

  2. Change in the concentration of blood lipids

    Time frame: 1 year

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

    Time frame: 1 year

  4. Change in body composition measured by Tanita BC 418

    Time frame: 1 year

  5. Change in quality of life assessed by PedsQL

    Time frame: 1 year

Other outcomes

  1. cost effectiveness

    Time frame: 1 year

    Assessed by the amount of hours used per child per year in each municipality

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Treatment of Overweight and Obese Children - the "Holbaek-Method" in a Municipality Based Treatment Program.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2013
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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