A program to promote healthy habits in children
Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention to Promote Healthy Weight and Wellbeing in Danish School-aged Children
This study is testing a program in schools to see if it can help kids aged 6-11 eat better, be more active, and sleep well, while also checking how it affects their overall health and weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1645 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 2 sites (Copenhagen, Capital Region And Region Zealand and 1 other locations) |
| Trial ID | NCT05940675 on ClinicalTrials.gov |
What this trial studies
The Generation Healthy Kids intervention is a cluster-randomized trial involving 24 schools in Denmark, aimed at improving weight development and overall well-being in children aged 6-11 years. This two-school-year program focuses on enhancing healthy diets, increasing physical activity, and improving sleep and screen time habits through a multi-component approach in both school and community settings. The trial will compare the effects of the intervention against a control group to assess its impact on body composition and various health outcomes. Additionally, the study will explore factors such as social inequality and potential modifiers of the intervention's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-9 years who are enrolled in 1st or 2nd grade at participating schools.
Not a fit: Children with severe allergies, chronic diseases, or mental/physical disabilities may not benefit from certain parts of the intervention but can still participate in others.
Why it matters
Potential benefit: If successful, this program could significantly reduce childhood obesity and improve overall health and well-being in children.
How similar studies have performed: Other studies have shown success with similar multi-component interventions aimed at promoting healthy behaviors in children, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children attending 1st or 2nd grade in the recruited schools Exclusion Criteria: - No exclusion criteria will be applied. If parents, teachers or research staff judge that a child cannot participate in certain parts of the intervention or measurement schedule, e.g. due to severe allergies, chronic diseases or mental/physical disabilities, the child will be eligible to participate in the remaining parts of the study.
Where this trial is running
Copenhagen, Capital Region And Region Zealand and 1 other locations
- 11 schools in the Capital Region of Denmark and Region Zealand — Copenhagen, Capital Region And Region Zealand, Denmark (Recruiting)
- 12 Schools in Region of Southern Denmark — Odense, Region Of Southern Denmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens Troelsen, PhD — University of Southern Denmark
- Study coordinator: Jesper Schmidt-Persson, PhD
- Email: jespedersen@health.sdu.dk
- Phone: +4565502054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.