Effects of the THAO-Child Health intervention program on the prevention of childhood obesity - the POIBC study
| ISRCTN | ISRCTN68403446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68403446 |
| Secondary identifying numbers | Instituto de Salud Carlos III FEDER, PI11/01900. |
- Submission date
- 22/07/2014
- Registration date
- 01/08/2014
- Last edited
- 07/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
IMIM-Hospital del Mar Medical Research Institute
Cardiovascular Risk and Nutrition Research Group
c/ Doctor Aiguader, 88
Barcelona
08003
Spain
| hschroeder@imim.es |
Study information
| Study design | Parallel intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| 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 | Effects of a lifestyle intervention on the prevention of childhood obesity: a community-based model - the POIBC study |
| Study acronym | POIBC |
| Study objectives | The THAO-Child Health intervention program favourably affects weight management, reduces incidence of obesity, and improves lifestyle. |
| Ethics approval(s) | Ethics Committee - CEIC-PSMAR, Barcelona, Spain, 21/11/2011, ref: 2011/4296/I |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2012 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 2140 |
| Key inclusion criteria | Healthy children aged 8 to 10 years |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
08003
Spain
Sponsor information
Research organisation
C/ Sinesio Delgado, 4
Madrid
28029
Spain
| registro.general@isciii.es | |
| Website | http://www.eng.isciii.es/ |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/08/2014 | Yes | No | |
| Other publications | 01/11/2018 | 27/09/2019 | Yes | No | |
| Other publications | 03/10/2024 | 07/10/2024 | Yes | No |
Editorial Notes
07/10/2024: Publication reference added.
27/09/2019: Publication reference added.
