NCT04522921Active, not recruiting
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (The COPE-study) - An Non-randomized Intervention Trial Investigating the Efficacy of Dietary Changes in Protein
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Secondary, the investigators want to investigate the effect of frequent follow-up after the intervention, and the overall effect of the lifestyle camp. Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve quality of life, and risk factors for type 2 diabetes.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 211 (actual)
- First submitted
- 13 Aug 2020
- Start date
- Oct 2020
- Primary completion date
- Jun 2023
- Lead sponsor
- University of Aarhus
- Diseases
- Obesity
- NCT number
- NCT04522921
What you commit to
- Study type: Interventional
- Participants enrolled: 211
- From Oct 2020 to the primary completion date, Jun 2023
- 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
- The child has a disease, diagnose or eating disorder that require treatment.
Other
- The child or parent/guardian participate in another clinical trial or plan to do so in the near future.
- The parent/guardian do not understand the written informed consent.
- The child or parent/guardian are unwilling to or unable to comply with the study protocol and instruction given by the study staff.
Who the study is looking for
- The child attends a multi-component-overnight camp in Hobro or Fjordmark between October 2020 and March 2022.
- The child is between 7 and 14 years of age (inclusive) while attending camp.
- At least one parent/guardian submit written and oral consent to participate with his/her child.
- Parent/legal guardian has submitted oral and written consent to participation of their child. In case of shared custody both parents must submit written and oral consent before their child can participate in the trial.
Age in the registry: 7 years to 14 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 |
|---|---|---|---|
| Weight Loss Camp Hobro Coordinator of this site? Confirm its status | Hobro | Denmark | Unknown status |
| Weight Loss Camp Fjordmark Coordinator of this site? Confirm its status | Kruså | Denmark | Unknown status |
Related publications
- Appetitive traits and long-term risk of disordered eating: a 3-year follow-up in children with overweight and obesity.Eat Weight Disord · 2026 · PMID 42159618
This page is information, not medical advice. Discuss any trial with your doctor.