NCT05940675Completed
Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
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
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
The GHK intervention was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. A pilot- and feasibility study was conducted during December 2022-April 2023, and the intervention was subsequently adapted and adjusted. The GHK main trial is a two-school-year cluster-randomized school- and community trial designed to investigate the effect of the multi-setting, multi-component GHK intervention program on weight development, health and wellbeing in Danish children aged 6-11 years. The trial will include 24 schools in Denmark (12 intervention and 12 control). The primary aim of the cluster-randomized trial is to investigate whether the GHK intervention program can promote healthy body composition as measured by fat mass (FM) in the intervention group compared with the control group. We hypothesize that the intervention will result in less FM gain in the intervention group compared with the control group over the two school-year study period.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1372 (actual)
- First submitted
- 4 Jul 2023
- Start date
- Aug 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- University of Copenhagen
- Diseases
- Obesity
- NCT number
- NCT05940675
What you commit to
- Study type: Interventional
- Participants enrolled: 1372
- From Aug 2023 to the primary completion date, Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- 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.
Who the study is looking for
- All children attending 1st or 2nd grade in the recruited schools
Age in the registry: 6 years to 11 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 11 schools in the Capital Region of Denmark and Region Zealand Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| 12 Schools in Region of Southern Denmark Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.