A Lifestyle Intervention Program in Children with Obesity (LIPCO)

ISRCTN	ISRCTN44919688
DOI	https://doi.org/10.1186/ISRCTN44919688
Protocol serial number	N/A
Sponsor	Health Authority, Västra Götaland (Sweden)
Funder	Healthcare Authority, Västra Götaland (Sweden)

Submission date: 03/01/2012
Registration date: 08/02/2012
Last edited: 31/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Staffan Mårild
Scientific

The Queen Silvia Children's Hospital
Department of Pediatrics
Sahlgrenska Academy
Göteborg University
Göteborg
SE 41685
Sweden

Email	staffan.marild@pediat.gu.se

Study information

Primary study design	Interventional
Study design	Multicenter randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	LIPCO
Study objectives	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(s)	Ethical Committee of Göteborg University, 09/12/2003, ref: Ö348-03
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	BMI - z score
Key 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
Completion date	01/02/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	25
Key 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
Key exclusion criteria	Syndromal obesity
Date of first enrolment	01/04/2004
Date of final enrolment	01/02/2007

Locations

Countries of recruitment

Sweden

Study participating centre

The Queen Silvia Children's Hospital

Göteborg
SE 41685
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes