Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/05/2009
Date assigned
15/07/2009
Last edited
15/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.fitvonkleinauf.de

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

http://www.bkk-ni-hb.de/

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

Publication citations

Additional files

Editorial Notes