Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/01/2018
Date assigned
23/02/2018
Last edited
22/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Worldwide, nutrition-related diseases have become a major health concern. The most apparent consequence of unhealthy diets and lack of physical activity is excess body weight and resulting cardiovascular and metabolic conditions. Many of these unfavourable health outcomes have developmental origins and track into adulthood with unacceptable human, social and economic costs. Social inequalities create unequal pressures and opportunities, relating to a range of environmental, social and economic factors, some of which impinge on diet, addictive behaviours, physical activity, sedentariness, media exposure and parenting. Factors conducive to ill health cluster in certain segments of the society, such as those who come from lower socioeconomic position, those with poor mental health or poor cognitive abilities, or who are immigrants. These inequalities call for efforts of European policy to increase social cohesion and quality of life and to encourage sustainable healthy lifestyles for all citizens, especially children. The aim of this study is to increase the knowledge of health and idet, and to develop approaches to increase health behaviour.

Who can participate?
Children aged 2 to 9.9 years old of the intervention regions.

What does the study involve?
Participants are asked to take part in a series of examinations and provide information about him/herself and about his/her family. Participants undergo anthropometric measurements such as weight and height, and circumference of waist, neck and arm. They are asked to fill in questionnaires to report on their family life, their behaviour in relation to eating, media use, sleep, physical activity, smoking and alcohol consume. They are also asked to provide a sample of saliva, and blood and urine in fasting status. Participants do a quick test to measure preference of taste. They are asked to wear a small device (accelerometer) for several days for measuring physical activity. They also fill in questionnaires to report on what was eaten or drank on the previous day using a computer program.
Those who perform computer tests for measuring decision making and reaction time (only T3).

What are the possible benefits and risks of participating?
Participants receive feedback on their examinations, for example their anthropometrical measurements, blood pressure, blood values, information on their sleep and nutritional and physical activity status, which they can discuss with their family physician. Participants also receive their results of the calcaneal ultrasonography for measuring bone stiffness. Participation at the IDEFICS/I.Family studies involves no risks.

Where is the study run from?
This study is being run by Leibniz Institute for Prevention Research and Epidemiology – BIPS (Germany) and takes place in Estonia, Germany, Hungary, Italy, Poland, Spain, Sweden, Belgium and Cyprus.

When is the study starting and how long is it expected to run for?
September 2006 to February 2017

Who is funding the study?
1. Sixth Framework Programme (EU)
2. Seventh Framework Programme (EU)

Who is the main contact?
1. Professor Wolfgang Ahrens (Scientific)
ahrens.ifamily@leibniz-bips.de
2. Mrs Ina Alvarez (Public)
alvarez@leibniz-bips.de

Trial website

http://www.ideficsstudy.eu; http://www.ifamilystudy.eu/

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Ahrens

ORCID ID

http://orcid.org/0000-0003-3777-570X

Contact details

Leibniz Institute for Prevention Research and Epidemiology - BIPS
Dept. Epidemiological Methods and Etiologic Research
Achterstrasse 30
Bremen
28359
Germany
+49 421 218 56820
ahrens.ifamily@leibniz-bips.de

Type

Public

Additional contact

Mrs Ina Alvarez

ORCID ID

Contact details

Leibniz Institute for Prevention Research and Epidemiology - BIPS
Dept. Epidemiological Methods and Etiologic Research
Achterstrasse 30
Bremen
28359
Germany
+49 421 218 56837
alvarez@leibniz-bips.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC 016181/EC 266044

Study information

Scientific title

Identification and prevention of dietary- and lifestyle-induced health effects in children and infants (IDEFICS), and determinants of eating behaviour in European children, adolescents and their parents (I.Family)

Acronym

IDEFICS/I.Family

Study hypothesis

IDEFICS:
1. Enhance knowledge of health effects of changing diet and altered social environment and lifestyle of children, 2-10 years, in Europe
2. Develop, implement and evaluate specific intervention approaches to reduce the prevalence of diet- and lifestyle-related diseases and disorders

I.Family:
1 Understand the interplay between barriers and main drivers of a healthy food choice
2. Identify predictors of unnecessary weight gain and cardio-metabolic risk by linking them to diet, physical activity and interacting factors while focusing on child and his / her family and assessing how different factors affect children as they grow up
3. Develop and convey strategies to induce changes towards a healthy behaviour

Ethics approval

1. Belgium: Ethics Committee of the Gent University Hospital, 15/10/2007, ref: No. EC UZG 2007/243 and 19/02/2013, No. B670201316342
2. Cyprus: Cyprus National Bioethics Committee, 12/07/2007, ref: No. EEBK/EM/2007/16 and 21/Feb/2013, No. EEBK/ETI/2012/33
3. Estonia: Tallinn Medical Research Ethics Committee (TMREC), 14/06/2007, ref: No. 1093 and 17/January 2013, No. 128
4. Germany: Ethic Commission of the University of Bremen, 16/01/2007 and 11/12/2012
5. Hungary: Medical Research Council, 21/Jun/2007, ref: 22-156/2007-1018EKU and 18/12/2012, 4536/2013/EKU
6. Italy: Ethics Committee of the Local Health Authority (ASL) in Avellino, 19/06/2007, ref: No. 2/CE and 18/Sep/2012, No. 12/12
7. Spain: Ethics Committee for Clinical Research of Aragon (CEICA), 20/06/2007, ref:No. PI07/13 and 13/Feb/2013, No. PI13/0012
8. Sweden: Regional Ethics Research Board in Gothenburg, 30/07/2007, ref: No. 264-07 and 10/Jan/2013, No. 927-12
9. Poland: Bioethical Committee of the University of Rzeszów, 05/06/2013 and 01/12/2015

Study design

The IDEFICS/I.Family was a prospective multi-centre cohort study. IDEFICS was complemented by a setting-based community-oriented intervention programme for primary prevention of obesity. It also included a case-control study component focussing on a) overweight/obesity, b) metabolic syndrome, and c) bone stiffness/bone health.
The funded period of each study was 5 years, with an extension of 6 months for the IDEFICS study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Nutrition and lifestyle-related disorders with a particular focus on overweight/obesity

Intervention

The community-oriented, setting-based IDEFICS intervention was developed using the intervention mapping protocol as a non-randomized controlled trial targeting physical activity, dietary behaviour and stress coping. Different modules at the community level, the (pre-) school level and the family level addressed six different target behavioural changes.

The baseline survey (T0, 2007-2008) took place in the intervention and control regions selected in Belgium, Cyprus, Estonia, Germany, Hungary, Italy, Spain and Sweden, enabling researchers to assess and describe the status quo of health and dietary and lifestyle habits of children in Europe taking into consideration regional, social, biological, and gender specific aspects. After this phase, the primary prevention programme was implemented only in the selected intervention regions, in which activities were offered for health promotion and prevention in kindergartens and schools. Each country selected one control and one intervention region. The short-term effects of the intervention were assessed during the second survey (T1) 2 years after baseline (2009-2010), repeating the same examinations in children from both, the control and intervention areas, for comparison between both regions. A mailed questionnaire was completed by parents at T2 (2010-2011) to assess the sustainability of the intervention. A third examination of the cohort members and their families took place in 2014/2015 (T3) when a ninth survey centre in Poland joined the cohort study with a baseline examination.

The IDEFICS intervention was designed to address three key obesity-related behaviours (diet, physical activity and stress coping) at four levels: individual (children), family (parents), schools and community. Six messages –two per key obesity-related behaviour- were delivered through 10 intervention modules across all levels: (i) increase the consumption of water, (ii) increase the consumption of fruit and vegetables, (iii) decrease daily television (TV) viewing time, (iv) increase daily physical activity, (v) strengthen parent–child relationships by spending more time together and (vi) establish adequate sleep duration.
The 3 first modules of the intervention were implemented at the community level:
Module 1. A "community platform" was established for the implementation of the other 2 modules. All local and relevant community members (local municipality, social services and welfare sector, private actors) were represented in this group.
Module 2. A long term multimedia and public relations campaign was performed to make the community aware of the intervention and the key behaviours targeted by the programme.
Module 3. It involved the development of a short and a long-term perspective for the prevention of childhood obesity to establish and induce environmental and policy interventions in the community.
The intervention at the school level consisted of 6 intervention modules:
Module 4. A school working group was established in all local participating schools, representing the school and parents' perspective on the intervention program, to provide insight in the realities of working with schools.
Module 5. It consisted of a curriculum-based intervention integrating the key behaviours in the classroom activities. "Healthy Weeks" focusing on a specific key behaviour related to nutrition or physical activity were organized during the school year, including homework for increasing the involvement of parents.
Module 6. It focused on environmental changes related to physical activity. Active playgrounds were created by providing attractive play tools (e.g. balls, ropes, small bikes) and/or by changing the physical design of the playground (e.g. hopscotch, soccer goal posts, basketball hoops).
Module 7. Practical guidelines were provided to teachers for reaching high(er) activity levels during physical education classes.
Modules 8 and 9. A supportive school environment was created by inducing changes in the school environment and policy related to water and fruit and vegetable consumption, e.g. providing the opportunity to drink water in class, making fruit and vegetables available and accessible in the class room or the school canteen.
The intervention at the family level (module 10) consisted of educational materials (posters and flyers) for parents providing them with strategies to remove barriers and support them in creating health promoting family environments.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Weight based on the age and sex specific BMI cutoffs were measured at T0, T1, and T3 using:
1.1. BMI was calculated as weight [kg] divided by height [m] squared
1. 2. Body weight and height were objectively measured using an adapted Tanita digital scale, BC 420 MA for children ≤6 years and BC 418 MA for children >6 years (weight) and a Seca 225 stadiometer (height)
3. Quality of the diet was measured using a healthy diet score and propensity scores based on a semi-quantitative food frequency questionnaire
4. Bone stiffness was measured by calcaneal ultrasonography (Lunar Achilles Insight) in in a sub-sample
5. Diet was measured using self-reported questionnaires (parents reported for their children at T0 and T1, and for children <12 at T3 ). Additionally, dietary assessment was conducted by a computer-based 24-hour dietary recall which was web-based in T3
6. Physical activity was measured using self-reported questionnaires and objectively measured using accelerometry (ActiTrainer or GT1M at T0 and T1 and ActiGraph GT3x at T3; Actigraph, LLC)
7. Sleep was measured using self-reported questionnaires (parents reported for their children at T0 and T1, and for children <12 at T3), and objectively measured using accelerometry in a subgroup at T3 (ActiTrainer or GT1M; Actigraph, LLC)
8. Family life was measured using self-reported questionnaires (parents reported for children below the age of 12)
9. Well-being was measured using self-reported questionnaires (parents reported for children below the age of 12)
10. Metabolic and nutritional biomarkers were measured using fasting blood and urine samples
11. Sensory taste perception was measured using questionnaire and by standard sensory tests in a subsample of children

Secondary outcome measures

1. Waist circumference was measured using a Seca 200 tape at the 3 time points (T0-T3)
2. Fat mass index and free fat mass index were calculated by skinfold thickness (subscapular, triceps and biceps) using Holtain Tanner/Whitehouse skinfold calipers and by bioelectrical impedance analysis using a digital TANITA BC 420 SMA scale at T0-T3
3. Blood pressure was measured using an automatic sphygmomanometer (WelchAllyn) at T0-T3
4. Metabolic syndrome at T1. This is calculated using a z-score standardisation to calculate a continuous score combining the MetS components (waist circumference, blood pressure, dyslipidaemia and hyperglycaemia). Three widely accepted definitions of the paediatric metabolic syndrome (MetS) are applied and suggested a new definition to guide paediatricians in decisions about close monitoring or even intervention (values of at least three of the MetS components exceeding the 90th or 95th percentile, respectively).
An online tool was developed to assist paediatricians when assessing the risk of metabolic syndrome in children aged 3-10 years. This tool and details on the MetS score can be found here: https://www.bips-institut.de/en/research/software/mets-score.html
5. Coordination was measured using physical fitness tests at T0 and T1
6. Motor fitness was measured using physical fitness tests derived from the EUROFIT test battery at T0 and T1 (Eurofit, (1993), Eurofit Tests of Physical Fitness, 2nd Edition, Strasbourg)
7. Cardiorespiratory fitness was measured using physical fitness tests derived from the EUROFIT test battery at T0 and T1 (Eurofit, (1993), Eurofit Tests of Physical Fitness, 2nd Edition, Strasbourg)
8. Handgrip strength was measured using a digital hand dynamometer TKK 5401 at T0 and T1
9. Built environment (regard to food outlets and opportunities for physical activities) was assessed by using objective data from geographic information system (GIS) at T0 and T3 in 2 study centres

Overall trial start date

01/09/2006

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. At the baseline survey (T0) all children, boys and girls, 2 to 9.9 years of age, attending the participating kindergartens and schools of the selected intervention and control areas in the 8 survey countries were eligible as participants. These criteria were extended to the Polish survey in 2014.
2. At the second wave of examinations (T1) all children who participated in T0 plus their classmates were invited to participate.
3. At the third wave (T3) all children who had participated either at T0 or T1 (index children) were re-invited together with their siblings in the age range 2-15 years, and both their parents.
4. Study subjects had to be residents of the selected control or intervention regions at T0.
5. Participant inclusion required that parents gave written informed consent for their children and in T3 also for themselves. Additionally, children from the age of 12 years onwards also had to give written informed consent.

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

The original recruitment aim at baseline (T0) was 2,000 children from each of the 8 participating cohort countries. A total of 16,228 children participated at the baseline survey. 11,041 children participated at T1 and 2,555 newly recruited children. At T3, 6,055 children participated and 2,512 newly recruited children (siblings). Additionally, 1002 children were recruited in Poland (T0 in Poland).

Participant exclusion criteria

1. Children outside the defined age rage
2. Children not living in the study regions at T0

Recruitment start date

01/09/2007

Recruitment end date

30/04/2016

Locations

Countries of recruitment

Belgium, Cyprus, Estonia, Germany, Hungary, Italy, Poland, Spain, Sweden

Trial participating centre

Leibniz Institute for Prevention Research and Epidemiology – BIPS
Bremen
28359
Germany

Trial participating centre

National Research Council, Institute of Food Sciences
Avellino
83100
Italy

Trial participating centre

National Institute for Health Development
Tallinn
11619
Estonia

Trial participating centre

Research and Education Institute of Child Health
Strovolos
2015
Cyprus

Trial participating centre

Ghent University, Faculty of Medicine and Health Sciences
Ghent
9000
Belgium

Trial participating centre

Göteborg University, Queen Silvia Children’s Hospital, Department of Paediatrics
Gothenburg
41686
Sweden

Trial participating centre

University of Zaragoza
Zaragoza
50009
Spain

Trial participating centre

University of Pécs, Medical Faculty, Department of Paediatrics
Budapest
1062
Hungary

Trial participating centre

University of Rzeszow, Faculty of Medicine
Rzeszów
35310
Poland

Sponsor information

Organisation

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Sponsor details

Achterstrasse 30
Bremen
28359
Germany
+49 421 218 56750
kontakt@leibniz-bips.de

Sponsor type

Research organisation

Website

https://www.bips-institut.de

Funders

Funder type

Government

Funder name

Sixth Framework Programme

Alternative name(s)

EC Sixth Framework Programme, European Commission Sixth Framework Programme, EU Sixth Framework Programme, European Union Sixth Framework Programme, EU 6th Framework Programme, European Union 6th Framework Programme, FP6

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programm, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, EU 7th Framework Programme, European Union 7th Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Results and Publications

Publication and dissemination plan

Numerous articles with results from the IDEFICS/I.Family cohort study have been published and many further publications are being prepared or planned. For publication lists see:
http://www.ideficsstudy.eu/publications.html
http://www.ifamilystudy.eu/project-publications/

The study protocol as well as the instruments of the IDEFICS/I.Family cohort study will be published in a book in 2018 by Springer Publishers. The corresponding reference will be provided once published.

IPD sharing statement:
All requests for accessing data of the IDEFICS/I.Family cohort are discussed on a case-by-case basis by the study Steering Committee. For this, interested parties are asked to provide details on the purpose of their request. The information is to be sent to:
Professor Dr Wolfgang Ahrens
Leibniz Institute for Prevention Research and Epidemiology - BIPS
Dept. Epidemiological Methods and Etiologic Research
Achterstrasse 30, 28359 Bremen, Germany
Tel: +49 / 421 / 218-56820
Fax: +49 / 421 / 218-56821
E-Mail: ahrens@leibniz-bips.de

Intention to publish date

01/10/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28040744

Publication citations

Additional files

Editorial Notes