A health tool kit: primary prevention of obesity of preschoolers - the fit von klein auf randomised study in Lower Saxony, Germany

ISRCTN	ISRCTN11131792
DOI	https://doi.org/10.1186/ISRCTN11131792
Secondary identifying numbers	4148

Submission date: 29/05/2009
Registration date: 15/07/2009
Last edited: 15/07/2009

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

Not provided at time of registration

Study website

Contact information

Prof Thomas Danne
Scientific

Kinderkrankenhaus auf der Bult
Janusz-Korczak-Allee 12
Hannover
30173
Germany

Phone	+49 (0)511 8115 3330
Email	danne@hka.de

Study information

Study design	Single centre randomised cross-over longitudinal prospective intervention study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Primary prevention of obesity of preschoolers in Lower Saxony, Germany: the Fit von klein auf single-centre, randomised, cross-over, longitudinal, prospective intervention study
Study acronym	KICK
Study objectives	To study if primary prevention of obesity in preschoolers is feasible already in four year olds with a health tool kit focussing on physical activity.
Ethics approval(s)	Ethikkommission der Medizinischen Hochschule Hannover approved on the 7th June 2006 (ref: 4148)
Health condition(s) or problem(s) studied	Paediatric obesity
Intervention	Intervention duration: 12 months Intervention measures: 1. Health tool kit "Fit von klein auf" (physical activity, nutrition, stress management) 2. Record card of physical exercises for care givers in the kindergarden 3. "Physical Activity Protocol" 4. Parental information sessions (psychology and nutrition)
Intervention type	Other
Primary outcome measure	Change in body mass index (BMI) standardised for gender and age, measured annually.
Secondary outcome measures	1. Body measures: height, weight, waist, hip and abdomen circumferences 2. Health related quality of life: KINDL-Kiddy (4 - 7 years) (interview and questionnaire for parents) 3. Motor performance: MOT 4 - 6 4. "Physical Activity Protocol" of kindergardens Measured annually.
Overall study start date	01/07/2006
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	900 children
Key inclusion criteria	1. Kindergartens selected on the basis of representativity for Lower Saxony 2. Boys and girls with birth date from 1st July 2001 until 31st December 2002 3. Informed consent of parents
Key exclusion criteria	1. Lack of consent 2. Physically and mentally handicapped children 3. Planned relocation during the study period
Date of first enrolment	01/07/2006
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

Germany

Study participating centre

Kinderkrankenhaus auf der Bult

Hannover
30173
Germany

Sponsor information

BKK Landesverband Niedersachsen/Bremen (Germany)
Government

Siebstr. 4
Hannover
30171
Germany

Phone	+49 (0)511 348 44 0
Email	info@bkk-ni-hb.de
Website	http://www.bkk-ni-hb.de/

Funders

Funder type

Government

BKK Landesverband Niedersachsen/Bremen (Germany) - health insurance company (http://www.bkk-ni-hb.de/)

No information available

National Action Forum for Diabetes Mellitus (Nationales Aktionsforum Diabetes Mellitus [NAFDM]) (Germany) (http://www.nafdm.de/)

No information available

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