A Lifestyle Intervention Program in Children with Obesity (LIPCO)
| ISRCTN | ISRCTN44919688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44919688 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
The Queen Silvia Children's Hospital
Department of Pediatrics
Sahlgrenska Academy
Göteborg University
Göteborg
SE 41685
Sweden
| staffan.marild@pediat.gu.se |
Study information
| Study design | Multicenter randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2004 |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 25 in each group |
| 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
SE 41685
Sweden
Sponsor information
Government
Västra Götalandsregionen
Box 1091
Göteborg
405 23
Sweden
| post@vgregion.se | |
| Website | http://www.vgregion.se/en/ |
"ROR" |
https://ror.org/00a4x6777 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
