CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 211 enrolled
Drug / intervention
Diet with a higher amount of protein (25E% per day) +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04522921
NCT04522921N/AActive

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

University of Aarhus·interventional·Posted Aug 21, 2020·Updated Apr 29, 2026

In Brief

A clinical study evaluating Diet with a higher amount of protein (25E% per day), Increased follow-up contact after the 10-week intervention, and 1 other intervention for Childhood Obesity and 4 related conditions. Active but no longer recruiting, targeting 211 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/AActive
2021202220232024202520262027202820292030203120322033
First PostedAug 21, 2020
Enrollment StartOct 1, 2020
Primary CompletionJun 30, 2023
Study CompletionDec 31, 2032
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.9 years ago

Interventions

Diet with a higher amount of protein (25E% per day)dietary

In a caloric restricted and increased physical activity setting, the participants will be served a higher protein (25E%/day) diet.

Increased follow-up contact after the 10-week interventionbehavioral

Both the control-group and the intervention-group were offered an increased follow-up contact after camp.

Diet with a lower amount of protein (15E% per day)dietary

In a caloric restricted and increased physical activity setting, the participants will be served a low-moderate protein (15E%/day) diet.