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Active, Not Recruiting

NCT Number: NCT04522921

Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Childhood Obesity Adolescent Obesity Adolescent Overweight Behavior Behavior, Animal Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Feeding Behavior Feeding and Eating Disorders Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Signs and Symptoms, Digestive

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weight Loss Camp Hobro, Hobro, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Body Mass Index Standard Deviation Score (BMI-SDS)

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

    BMI-SDS was calculated using World Health Organization Anthro-Plus software.

  2. Body Weight (kg)

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

    Body weight (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

  3. Body Fat (%)

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

    Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

  4. Skeletal Muscle Mass (kg)

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

    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).

Secondary outcomes

  1. Body Height (m)

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

    Height (m) was measured using a fixed wall measuring tape.

  2. Systolic Blood Pressure

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

    Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).

  3. Diastolic Blood Pressure

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

    Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).

  4. P-cholesterol

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  5. HDL Cholesterol

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  6. LDL Cholesterol

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  7. P-tryglyceride

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  8. ALAT

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  9. ASAT

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  10. GGT

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  11. Basic Phosphatase

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  12. HbA1c

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  13. P-glucose

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  14. Albumin

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  15. CD163

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  16. Platelets

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

  17. Uric Acid

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

    Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: COPE

Important dates

Study start
2020
Primary completion
2023
Study completion
2032
First posted
Aug 21, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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