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A Lifestyle Intervention Program in Children with Obesity (LIPCO)
ISRCTN ISRCTN44919688
DOI 10.1186/ISRCTN44919688
ClinicalTrials.gov identifier
EudraCT number
Public title A Lifestyle Intervention Program in Children with Obesity (LIPCO)
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
Serial number at source N/A
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.
Lay 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
Ethics approval Ethical Committee of Göteborg University, 09/12/2003, ref: Ö348-03
Study design Multicenter randomised controlled trial
Countries of recruitment Sweden
Disease/condition/study domain Obesity
Participants - 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
Participants - exclusion criteria Syndromal obesity
Anticipated start date 01/04/2004
Anticipated end date 01/02/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 25 in each group
Interventions 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.
Primary outcome measure(s) BMI - z score
Secondary outcome measure(s) 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
Sources of funding Healthcare Authority, Västra Götaland (Sweden)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23172847
Contact name Dr  Staffan  Mårild
  Address The Queen Silvia Children's Hospital
Department of Pediatrics
Sahlgrenska Academy
Göteborg University
  City/town Göteborg
  Zip/Postcode SE 41685
  Country Sweden
  Email staffan.marild@pediat.gu.se
Sponsor Health Authority, Västra Götaland (Sweden)
  Address Västra Götalandsregionen
Box 1091
  City/town Göteborg
  Zip/Postcode 405 23
  Country Sweden
  Email post@vgregion.se
  Sponsor website: http://www.vgregion.se/en/
Date applied 03/01/2012
Last edited 31/07/2014
Date ISRCTN assigned 08/02/2012
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