Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/07/2014
Date assigned
01/08/2014
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.eng.isciii.es/

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25174356

Publication citations

Additional files

Editorial Notes