Plain English Summary
Background and study aims
The increasing rate of childhood obesity is a serious worldwide public health problem. Community-based intervention programs are a holistic approach to prevent childhood obesity. We want to find out the effect of a community-based intervention program called the THAO-Child Health program on weight development and lifestyle of children and their families.
Who can participate?
This study aims to recruit 2140 boys and girls aged 8 to 10 years (4th and 5th grade of elementary school).
What does the study involve?
The four cities where the programme will be implemented will be randomly allocated to two groups. The THAO-Child Health Program will be implemented in the cities of Terrassa and Sant Boi de Llobregat. The other two cities, Molins de Rei and Gavà, will act as the control group and will not receive the THAO-Child Health Program. Repeated measures of dietary intake and behaviour, physical activity, sleep quality, quality of life, and changes in the body composition will be performed among all participating children. Additionally, parental social and demographic changes, diet quality, and physical activity will be recorded.
What are the possible benefits and risks of the participants?
Participants in the intervention group may benefit from effective weight management and lifestyle improvements.
Where is the study run from?
The study is run from four Catalan cities in Spain (Terrassa, Sant Boi de Llobregat, Molins de Rei, and Gavà).
When is the study starting and how long is it expected to run for?
From January 2012 to December 2014.
Who is funding the study?
Institute of Health Carlos III (Instituto de Salud Carlos III), Feder, Madrid (Spain).
Who is the main contact?
Dr Helmut Schröder
hschroeder@imim.es
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helmut Schröder
ORCID ID
Contact details
IMIM-Hospital del Mar Medical Research Institute
Cardiovascular Risk and Nutrition Research Group
c/ Doctor Aiguader
88
Barcelona
08003
Spain
-
hschroeder@imim.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Instituto de Salud Carlos III FEDER, PI11/01900.
Study information
Scientific title
Effects of a lifestyle intervention on the prevention of childhood obesity: a community-based model - the POIBC study
Acronym
POIBC
Study hypothesis
The THAO-Child Health intervention program favourably affects weight management, reduces incidence of obesity, and improves lifestyle.
Ethics approval
Ethics Committee - CEIC-PSMAR, Barcelona, Spain, 21/11/2011, ref 2011/4296/I
Study design
Parallel intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
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
Community-based intervention in two Catalan cities. Two other cities serve as the control cities. The intervention cities receive health promotion materials and actions, permanent training of the local coordinators and the development of an assessment and communication plan. This is not the case in the two cities serving as control. Primary and secondary outcomes will be measured in both groups. The intervention lasts 2 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Weight
2. Height
3. Waist circumference
All primary outcomes will be measured at the beginning and the end of the study.
Secondary outcome measures
1. Dietary habits
2. Physical activity
3. Sleep quality
4. Quality of life
Will all be measured at the beginning and end of the study
5. Food intake - will be measured at the beginning, the midpoint, and the end of the study
All secondary outcomes to be measured with validated questionnaires
Overall trial start date
01/01/2012
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy children aged 8 to 10 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2140
Participant exclusion criteria
N/A
Recruitment start date
01/01/2012
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Spain
Trial participating centre
IMIM-Hospital del Mar Medical Research Institute
Barcelona
08003
Spain
Sponsor information
Organisation
Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
Sponsor details
C/ Sinesio Delgado
4
Madrid
28029
Spain
-
registro.general@isciii.es
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Instituto de Salud Carlos III
Alternative name(s)
Institute of Health Carlos III, Carlos III Health Institute, ISCIII
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Spain
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25174356