Pan-European IDEFICS/I.Family children cohort

• Register: ISRCTN
• Last refreshed on: 19 December 2023
• Main ID: ISRCTN62310987
• Date of registration: 23/02/2018
• Prospective Registration: No
• Primary sponsor: Leibniz Institute for Prevention Research and Epidemiology - BIPS
• Public title: Pan-European IDEFICS/I.Family children cohort
• 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)
• Date of first enrolment: 01/09/2007
• Target sample size: 20000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN62310987
• Study type: Interventional
• 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. (Prevention)
• Phase: Not Applicable

Countries of recruitment

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

Contacts

• Name: Ina Alvarez

• Name: Wolfgang Ahrens

Key inclusion & exclusion criteria

Inclusion criteria: 1. At the baseline survey (T0) all children, boys and girls, 2 - 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.
Exclusion criteria: 1. Children outside the defined age rage
2. Children not living in the study regions at T0

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Nutrition and lifestyle-related disorders with a particular focus on overweight/obesity
Nutritional, Metabolic, Endocrine
Nutrition and lifestyle-related disorders with a particular focus on overweight/obesity

Intervention(s)

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-r

Primary Outcome(s)

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(s)

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

Secondary ID(s)

EC 016181/EC 266044

Nil known

Source(s) of Monetary Support

Sixth Framework Programme, Seventh Framework Programme

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 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: Me

Results

• Results available: Yes
• Date Completed: 28/02/2017