Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/08/2015
Date assigned
10/09/2015
Last edited
03/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Childhood obesity is a serious health risk worldwide. Studies have shown that obesity in childhood can lead to serious conditions in adulthood, such as diabetes and heart disease. Beyond this, being overweight as a child can seriously affect physical and emotional development, and therefore effective treatments are urgently needed. Fat (adipose tissue) produces a number of chemicals known as adipocytokines such as leptin and adiponectin, which are important for controlling metabolism. Leptin works by telling the brain that the body has enough fat stored. Because the more fat there is, the more leptin is produced; people with obesity have very high levels of leptin, which leads to the body becoming resistant to its effects, causing a person to eat more and use less energy, increasing the risks of obesity-related diseases. Adiponectin on the other hand is anti-inflammatory, and can actually help prevent these diseases. It has been found that in people who are obese, levels of adiponectin are lower than normal, which increases the risk of diabetes and heart disease. Adipose tissue also releases chemicals that co-ordinate inflammation, such as c-reactive protein (CRP), which can lead to increased risk of obesity-related diseases when raised. It is thought that eating more healthily and exercising more can help to re-regulate these chemicals. The aim of this study is to find out whether a program which motivating children to exercise and eat healthily can help weight loss and cause changes to the levels of adiponectin, leptin and CRP.

Who can participate?
Overweight or obese children, with a BMI of more than 22.

What does the study involve?
Children and their families are invited to take part in a lifestyle intervention lasting for one year. Within the year, they attend seven outpatient appointments in the pediatric department. These appointments include physical examinations, guidance for having a more healthy diet and motivational behavioral therapy, encouraging children to change their habits in order to lose weight. The children also take part in an exercise program twice a week, including one hour of physical activity. Weight changes are monitored throughout the study, and the children have blood tests at the start and end of the study to measure their levels of adiponectin, leptin and CRP. One year after the study ends, children and their families are invited to a follow up examination with a nurse.

What are the possible benefits and risks of participating?
Benefits of participating include weight loss and a lower risk of heart disease, stroke and obesity. There are no real risks of participating, apart from discomfort during the collection of blood samples.

Where is the study run from?
Department of Pediatrics, Regional Hospital Viborg (Denmark)

When is the study starting and how long is it expected to run for?
January 2010 to January 2012

Who is funding the study?
1. Department of Pediatrics, Regional Hospital Viborg (Denmark)
2. Council of Sport, Municipality of Viborg (Denmark)

Who is the main contact?
Dr Charlotte Eggertsen
c.eggertsen@rn.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Eggertsen

ORCID ID

Contact details

Department of Pediatrics
Reberbansgade 10-12
Aalborg
9000
Denmark
+45 5190 5084
c.eggertsen@rn.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Investigations of levels of adiponectin, leptin, and CRP in a cohort of 11-13-years old children before and after a lifestyle intervention program.

Acronym

Study hypothesis

Our study investigates the effect of a multidisciplinary family-based intervention program on the level of weight reduction, focusing on changes in diet, structural physical activity and motivational behavior therapy among obese 11-13 years old, obese Danish children. The investigation included an assessment of the association between measurements of obesity and levels of adipocytokines and CRP.

Ethics approval

1. Danish National Committee on Biomedical Research Ethics, 25/01/2012, ref: 1-10-72-567-12
2. Danish Data Protection Agency, 27/06/2011, ref: 2007-58-0010.

Study design

Interventional multidisciplinary study.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

This material is only available in Danish

Condition

Obesity

Intervention

The children and their families are followed at the out-patient clinic at the Pediatric Department at 7 consultations during one year. Three visits are individual and included physical examination by pediatrician. Six visits included motivational behavioral therapy individually (2 visits) or in small groups (4 visits) leaded by child psychologist, pediatrician and pediatric nurse.
The exercise program is organized by two health workers and performed two times a week, including 60 minutes of physical exercise. The children and their families receive three individual nutritional guidance sessions by a clinical dietitian in addition to six cooking arrangements during the intervention program.
One year after the intervention ended the children and their families are re-invited to a follow-up examination conducted by a pediatric nurse in the out-patients clinic.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. The degree of weight loss and weight changes. Weight, height and BMI was registrated every third month during the intervention period.
2. Changes in adiponectin, leptin and c-reactive protein (CRP) are measured before and after the intervention. Adiponectin (mg/l) is determined by a validated in-house time-resolved immunofluorometric assay based on two monoclonal antibodies and recombinant human adiponectin (obtained from R&D Systems, Abingdon, UK). Leptin (µg/l) is determined by a validated in-house time-resolved immunofluorometric assay based on commercial available monoclonal antibodies and recombinant human leptin (R&D Systems, Abingdon, UK). CRP levels are determined by a high sensitive CRP (hsCRP) TRIFMA assay based on commercial available monoclonal antibodies (R&D systems).

Secondary outcome measures

1. Waist circumference, measured every third month during the intervention.
2. Hip circumference, measured every third month during the intervention.
3. Blood pressure, measured every third month during the intervention.

Overall trial start date

01/09/2009

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 11-13 years
2. BMI ≥ 22 (this value at the age of 12 years old correlates to BMI of 25 in an adult)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

30

Participant exclusion criteria

Considerable comorbidity which would make participation in structural physical activity impossible.

Recruitment start date

01/09/2009

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Denmark

Trial participating centre

Pediatric Department
Regionshospitalet Viborg (Regional hospital Viborg) Heibergs Alle 4
Viborg
8800
Denmark

Sponsor information

Organisation

Regional Hospital Viborg

Sponsor details

Department of pediatrics
Heibergs Alle 4
Viborg
8800
Denmark
+45 5190 5084
c.eggertsen@rn.dk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Pediatrics, Regional Hospital Viborg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Council of Sport, Municipality of Viborg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

An article will be submitted to the journal Acta Paediatrica, where the study design and results will be described.

Intention to publish date

31/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes