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 |
| Protocol serial number | 4148 |
| Sponsor | BKK Landesverband Niedersachsen/Bremen (Germany) |
| Funders | BKK Landesverband Niedersachsen/Bremen (Germany) - health insurance company (http://www.bkk-ni-hb.de/), National Action Forum for Diabetes Mellitus (Nationales Aktionsforum Diabetes Mellitus [NAFDM]) (Germany) (http://www.nafdm.de/) |
- 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
Contact information
Prof Thomas Danne
Scientific
Scientific
Kinderkrankenhaus auf der Bult
Janusz-Korczak-Allee 12
Hannover
30173
Germany
| Phone | +49 (0)511 8115 3330 |
|---|---|
| danne@hka.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised cross-over longitudinal prospective intervention study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Change in body mass index (BMI) standardised for gender and age, measured annually. |
| Key secondary outcome measure(s) |
1. Body measures: height, weight, waist, hip and abdomen circumferences |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 900 |
| 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
30173
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
