Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/01/2012
Date assigned
08/02/2012
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Childhood obesity has become a common disease since the 1980s. The aim of this study was to implement and compare two different 12-month lifestyle treatment protocols for 10-year old children with obesity in primary pediatric care.

Who can participate?
Children aged 10 years with obesity.

What does the study involve?
Children were referred from school health care and were randomly allocated to one of the two programs. The children undergoing treatment were assessed medically at the start of the study and after 1 year. Measurements of weight, height, waist circumference, blood pressure and biological markers in the blood were carried out at assessments. For comparison, normal weight and overweight children were also studied in parallel, but no intervention took place in these children. A waiting list control group of children with obesity, not receiving treatment, were also used for comparison.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
The study was performed in the region of Västra Götaland in Sweden at four pediatric outpatient wards.

When is the study starting and how long is it expected to run for?
The study ran from April 2004 to February 2007.

Who is funding the study?
Healthcare Authority, Västra Götaland (Sweden).

Who is the main contact?
Staffan Mårild
staffan.marild@pediat.gu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Staffan Mårild

ORCID ID

Contact details

The Queen Silvia Children's Hospital
Department of Pediatrics
Sahlgrenska Academy
Göteborg University
Göteborg
SE 41685
Sweden
staffan.marild@pediat.gu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A one-year lifestyle intervention program emphasizing physical activity versus a conventional program in 10 year old children with obesity: a randomised controlled trial

Acronym

LIPCO

Study hypothesis

Putting an emphasis on physical activity in the treatment of children with obesity will result in a more favorable 1 year outcomes of body mass index (BMI), waist circumference, and metabolic markers than a protocol without such components.

Ethics approval

Ethical Committee of Göteborg University, 09/12/2003, ref: Ö348-03

Study design

Multicenter randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

At each of the four centres, nurses and dieticians met children and parents 12 times during 1 year.

Both arms had most elements in common. The children were included and randomized to either treatment arm consecutively. They were examined immediately before and directly after the intervention by a pediatrician. Special attention was given to anthropometric and blood pressure measurements, blood sampling for markers of the metabolic syndrome and a detailed parental questionnaire. All had 12 one-hour visits during a 12-month period, when parents and children met pediatric nurses four times or dieticiansfour times.

The remaining four visits were planned to differ for the two arms: in one a physiotherapist met the child and its parents and had the task to stimulate an increase in daily physical activity. Pedometers, reduction-of-TV-viewing-curricula and special fun diaries, phone reminders and support at follow-up visits were used to emphasize/stimulate physical activity in the family lifestyle. In the other arm, the pediatric nurse had the corresponding four visits using 'conventional' methods.

Motivational interviewing and lifestyle change protocols where cognitive behavior techniques were used and common methods for all personnel in both arms.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

BMI - z score

Secondary outcome measures

1. Waist circumference
2. Homeostatic Model Assessment (HOMA) score
3. Lipids and other markers in blood

Measured 4-5 years after the start of the treatment

Overall trial start date

01/04/2004

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 10 years with obesity defined by the International Obesity Task Force (IOTF) cut-offs
2. Informed consent given from the parents of all patients

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25 in each group

Participant exclusion criteria

Syndromal obesity

Recruitment start date

01/04/2004

Recruitment end date

01/02/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

The Queen Silvia Children's Hospital
Göteborg
SE 41685
Sweden

Sponsor information

Organisation

Health Authority, Västra Götaland (Sweden)

Sponsor details

Västra Götalandsregionen
Box 1091
Göteborg
405 23
Sweden
post@vgregion.se

Sponsor type

Government

Website

http://www.vgregion.se/en/

Funders

Funder type

Government

Funder name

Healthcare Authority, Västra Götaland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23172847

Publication citations

  1. Results

    Mårild S, Gronowitz E, Forsell C, Dahlgren J, Friberg P, A controlled study of lifestyle treatment in primary care for children with obesity., Pediatr Obes, 2013, 8, 3, 207-217, doi: 10.1111/j.2047-6310.2012.00105.x.

Additional files

Editorial Notes