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
Protocol serial number	Instituto de Salud Carlos III FEDER, PI11/01900.
Sponsor	Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
Funder	Instituto de Salud Carlos III

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Helmut Schröder
Scientific

IMIM-Hospital del Mar Medical Research Institute
Cardiovascular Risk and Nutrition Research Group
c/ Doctor Aiguader, 88
Barcelona
08003
Spain

Email	hschroeder@imim.es

Study information

Primary study design	Interventional
Study design	Parallel intervention study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Weight 2. Height 3. Waist circumference All primary outcomes will be measured at the beginning and the end of the study.
Key secondary outcome measure(s)	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
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	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

IMIM-Hospital del Mar Medical Research Institute

Barcelona
08003
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/10/2024: Publication reference added.
27/09/2019: Publication reference added.