Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

NCT04522921 | Active Not Recruiting Results

• 1 other identifier: The COPE-study
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Childhood Obesity; Overweight and Obesity; Adolescent Obesity; Adolescent Overweight; Diabetes

Keywords

Eating Behavior; Eating Habit; Quality of Life; Dietary Habits; Eating Disorders

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• Body Height (m)

  Mean changes from baseline to 10-weeks (post camp intervention)

• Systolic Blood Pressure

  Mean changes from baseline to 10-weeks (post camp intervention)

• Diastolic Blood Pressure

  Mean changes from baseline to 10-weeks (post camp intervention)

• P-cholesterol

  Mean changes from baseline to 10-weeks (post camp intervention)

• HDL Cholesterol

  Mean changes from baseline to 10-weeks (post camp intervention)

Study Arms (3)

SARS CoV-group

OTHER

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)

Control Group (CG)

ACTIVE COMPARATOR

Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp. Increased follow-up contact after camp.

Behavioral: Increased follow-up contact after the 10-week intervention; Dietary Supplement: Diet with a lower amount of protein (15E% per day)

Intervention group (IG)

EXPERIMENTAL

A higher protein diet (25E%/day) for the 10 weeks they attend the camp. Increased follow-up contact after camp.

Dietary Supplement: Diet with a higher amount of protein (25E% per day); Behavioral: Increased follow-up contact after the 10-week intervention

Interventions

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

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

Intervention group (IG)

Increased follow-up contact after the 10-week intervention BEHAVIORAL

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

Control Group (CG); Intervention group (IG)

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

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

Control Group (CG); SARS CoV-group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Weight Loss Camp Hobro

Hobro, 9500, Denmark

Location

Weight Loss Camp Fjordmark

Kruså, 6340, Denmark

Location

Related Publications (5)

• 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.

  PMID: 38724826 RESULT

• 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.

  PMID: 38705820 RESULT

• 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.

  PMID: 40157300 RESULT

• 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.

  PMID: 37777600 RESULT

• 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.

  PMID: 37285233 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Diabetes Mellitus; Feeding Behavior; Feeding and Eating Disorders

Interventions

Diet; Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior, Animal; Behavior; Signs and Symptoms, Digestive; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Investigative Techniques

Results Point of Contact

• Title: Dorthe Dalstrup Pauls
• Organization: Department of Clinical Medicine, Aarhus University / Steno Diabetes Center Aarhus, Aarhus University Hospital

dorthedalstrup@clin.au.dk

+45 28256406

Study Officials

• Jens M Bruun, Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: At enrollment the participants have no knowledge of which group they are assigned. The investigator has no knowledge of or influence on how participants are divided into different groups. Participants are assigned groups by the camp staff.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. SARS CoV group (former control group): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp, however, due to a COVID19 lockdown of the camps, these children were sent home for five weeks, and therefore excluded from longitudinal comparison between the groups. 2. Control group (CG): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp. 2\) Intervention group (IG): A higher protein diet (25E%/day) for the 10 weeks they attend the camp.

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 21, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2023
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 29, 2026
• Results First Posted: August 22, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)