NCT04522921

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The study will be performed in collaboration with the staff of the well-established multi-component-overnight camps (Julemærkehjem) in Denmark. The multi-component-overnight camps are intensive weight loss camps to which Danish schoolchildren, from 7-14 years of age, are referred to for 10-weeks intervention focusing on healthy lifestyle, healthy eating, new habits and increased physical activity. The primary outcome is anthropometry (BMI-SDS, fat mass, fat-free mass). Secondary outcomes are metabolic health and questionnaires investigating quality of life, eating behavior traits, eating habits and eating-related problems i.e., overeating and loss of control eating. The children will be measured at baseline, 10-weeks and at a 52-weeks follow-up visit. Furthermore, participants will be invited to follow-up visits 3 years, 5 years, 7 years and 10 years, respectively.

Conditions

• Childhood Obesity
• Overweight and Obesity
• Adolescent Obesity
• Adolescent Overweight
• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diet with a higher amount of protein (25E% per day)	In a caloric restricted and increased physical activity setting, the participants will be served a higher protein (25E%/day) diet.
BEHAVIORAL	Increased follow-up contact after the 10-week intervention	Both the control-group and the intervention-group were offered an increased follow-up contact after camp.
DIETARY_SUPPLEMENT	Diet with a lower amount of protein (15E% per day)	In a caloric restricted and increased physical activity setting, the participants will be served a low-moderate protein (15E%/day) diet.

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-06-30
• Completion: 2032-12-31
• First posted: 2020-08-21
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

2 sites across 1 country: Denmark