Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (COPE)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Childhood Obesity; Adolescent Obesity; Overweight and Obesity; Adolescent Overweight
• Intervention / Treatment: Dietary supplement: Diet with a lower amount of protein (15E% per day); Behavioral: Increased follow-up contact after the 10-week intervention; Dietary supplement: Diet with a higher amount of protein (25E% per day)

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.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hobro, Denmark, 9500
    • Weight Loss Camp Hobro
  • Kruså, Denmark, 6340
    • Weight Loss Camp Fjordmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The child has a disease, diagnose or eating disorder that require treatment.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SARS CoV-group; This group should have been the control group. However, due to the COVID19 lockdown of the camps for 5 five weeks, with no control of diet and physical activity, this group could not act as control group. Therefore, this group has been excluded from longitudinal analyses.	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.
Active Comparator: Control Group (CG); Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp. 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.; 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.
Experimental: Intervention group (IG); A higher protein diet (25E%/day) for the 10 weeks they attend the camp. Increased follow-up contact after camp.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index Standard Deviation Score (BMI-SDS)	BMI-SDS was calculated using World Health Organization Anthro-Plus software.	Mean changes from baseline to 10-weeks (post camp intervention)
Body Weight (kg)	Body weight (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).	Mean changes from baseline to 10-weeks (post camp intervention)
Body Fat (%)	Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).	Mean changes from baseline to 10-weeks (post camp intervention)
Skeletal Muscle Mass (kg)	Skeletal muscle mass (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).	Mean changes from baseline to 10-weeks (post camp intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Height (m)	Height (m) was measured using a fixed wall measuring tape.	Mean changes from baseline to 10-weeks (post camp intervention)
Systolic Blood Pressure	Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).	Mean changes from baseline to 10-weeks (post camp intervention)
Diastolic Blood Pressure	Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).	Mean changes from baseline to 10-weeks (post camp intervention)
P-cholesterol	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
HDL Cholesterol	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
LDL Cholesterol	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
P-tryglyceride	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
ALAT	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
ASAT	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
GGT	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
Basic Phosphatase	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
HbA1c	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
P-glucose	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
Albumin	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
CD163	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
Platelets	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)
Uric Acid	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.	Mean changes from baseline to 10-weeks (post camp intervention)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Jens M Bruun, Professor, Aarhus University Hospital

Publications and helpful links

General Publications

• Jakobsen DD, Brader L, Bruun JM. Effect of a higher protein diet and lifestyle camp intervention on childhood obesity (The COPE study): results from a nonrandomized controlled trail with 52-weeks follow-up. Eur J Nutr. 2024 Sep;63(6):2173-2184. doi: 10.1007/s00394-024-03420-z. Epub 2024 May 9.
• Jakobsen DD, Jarvholm K, Brader L, Bruun JM. Long-term changes in eating-related problems and quality of life in children with overweight and obesity attending a 10-week lifestyle camp. Obes Res Clin Pract. 2024 May-Jun;18(3):209-215. doi: 10.1016/j.orcp.2024.04.002. Epub 2024 May 4.
• Pauls DD, Clausen L, Bruun JM. Eating behavior profiles in children following a 10-week lifestyle camp due to overweight/obesity and low quality of life: A latent profile analysis on eating behavior. Eat Behav. 2025 Apr;57:101971. doi: 10.1016/j.eatbeh.2025.101971. Epub 2025 Mar 24.
• Aagaard I, Jakobsen DD, Bruun JM. Association between quality of life and emotional overeating - a cross-sectional study in Danish children attending a multicomponent lifestyle camp. Eur J Pediatr. 2023 Dec;182(12):5493-5499. doi: 10.1007/s00431-023-05206-7. Epub 2023 Sep 30.
• Orry S, Dalstrup Jakobsen D, Kristensen NM, Meldgaard Bruun J. Uric acid and sCD163 as biomarkers for metabolic dysfunction and MAFLD in children and adolescents with overweight and obesity. J Pediatr Endocrinol Metab. 2023 Jun 8;36(7):643-649. doi: 10.1515/jpem-2023-0228. Print 2023 Jul 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Eating Behavior; Eating Disorders; Dietary Habits; Eating Habit
• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Overweight; Obesity; Diabetes Mellitus; Pediatric Obesity; Feeding and Eating Disorders; Feeding Behavior; Investigative Techniques; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Methods; Diet
• Other Study ID Numbers: The COPE-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No