Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Thomas Danne
ORCID ID
Contact details
Kinderkrankenhaus auf der Bult
Janusz-Korczak-Allee 12
Hannover
30173
Germany
+49 (0)511 8115 3330
danne@hka.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4148
Study information
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
Acronym
KICK
Study hypothesis
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
Ethikkommission der Medizinischen Hochschule Hannover approved on the 7th June 2006 (ref: 4148)
Study design
Single centre randomised cross-over longitudinal prospective intervention study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2006
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
900 children
Participant exclusion criteria
1. Lack of consent
2. Physically and mentally handicapped children
3. Planned relocation during the study period
Recruitment start date
01/07/2006
Recruitment end date
30/06/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Kinderkrankenhaus auf der Bult
Hannover
30173
Germany
Sponsor information
Organisation
BKK Landesverband Niedersachsen/Bremen (Germany)
Sponsor details
Siebstr. 4
Hannover
30171
Germany
+49 (0)511 348 44 0
info@bkk-ni-hb.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
BKK Landesverband Niedersachsen/Bremen (Germany) - health insurance company (http://www.bkk-ni-hb.de/)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Action Forum for Diabetes Mellitus (Nationales Aktionsforum Diabetes Mellitus [NAFDM]) (Germany) (http://www.nafdm.de/)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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