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
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
-
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.