Childhood ObesityCOPENCT04522921
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
A study testing Diet with a higher amount of protein (25E% per day), Increased follow-up contact after the 10-week intervention and Diet with a lower amount of protein (15E% per day) in people with Childhood Obesity and Overweight and Obesity, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Overweight and Obesity, Adolescent Obesity
- What is being tested?
- Diet with a higher amount of protein (25E% per day), Increased follow-up contact after the 10-week intervention and Diet with a lower amount of protein (15E% per day)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2020to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Weight Loss Camp Hobro
Hobro, 9500
Weight Loss Camp Fjordmark
Kruså, 6340
About this study
Official 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
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.
Read the 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
- Being tested
- Diet with a higher amount of protein (25E% per day), Increased follow-up contact after the 10-week intervention, Diet with a lower amount of protein (15E% per day)
- Keywords
- Eating Behavior, Eating Habit, Quality of Life, Dietary Habits, Eating Disorders
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity, Diabetes Mellitus, Feeding Behavior, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Diet with a higher amount of protein (25E% per day); Behavioral: Increased follow-up contact after the 10-week intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Standard Deviation Score (BMI-SDS)
BMI-SDS was calculated using World Health Organization Anthro-Plus software.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Mean changes from baseline to 10-weeks (post camp intervention)
Secondary outcomes (17)
Body Height (m)
Height (m) was measured using a fixed wall measuring tape.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Mean changes from baseline to 10-weeks (post camp intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2023
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens M Bruun, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522921
- Sponsor's protocol ID
- The COPE-study
- Acronym
- COPE
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2020
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38724826Jakobsen 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.
PubMed 38705820Pauls 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.
PubMed 40157300Aagaard 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.
PubMed 37777600Orry 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.
PubMed 37285233Christofersen GD, Pauls DD, Bruun JM. Appetitive traits and long-term risk of disordered eating: a 3-year follow-up in children with overweight and obesity. Eat Weight Disord. 2026 May 20;31(1):68. doi: 10.1007/s40519-026-01868-y.
PubMed 42159618
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04522921
- Acronym / sponsor ID
- COPE / The COPE-study
- Conditions
- Childhood Obesity, Overweight and Obesity, Adolescent Obesity, Adolescent Overweight, Diabetes
- Keywords
- Eating Behavior, Eating Habit, Quality of Life, Dietary Habits, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SARS CoV-group | Other | Dietary Supplement: Diet with a lower amount of protein (15E% per day)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. |
| Control Group (CG) | Active comparator | Behavioral: Increased follow-up contact after the 10-week intervention, Dietary Supplement: Diet with a lower amount of protein (15E% per day)Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp. Increased follow-up contact after camp. |
| Intervention group (IG) | Experimental | Dietary Supplement: Diet with a higher amount of protein (25E% per day), Behavioral: Increased follow-up contact after the 10-week interventionA higher protein diet (25E%/day) for the 10 weeks they attend the camp. Increased follow-up contact after camp. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Intervention group (IG) |
| Increased follow-up contact after the 10-week interventionBoth the control-group and the intervention-group were offered an increased follow-up contact after camp. | Behavioural | Control Group (CG), Intervention group (IG) |
| 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. | Dietary supplement | Control Group (CG), SARS CoV-group |
Primary outcome
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.
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).
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).
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).
17 secondary outcomes
Body Height (m)
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Systolic Blood Pressure
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Diastolic Blood Pressure
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
P-cholesterol
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
HDL Cholesterol
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
LDL Cholesterol
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
P-tryglyceride
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
ALAT
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
ASAT
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
GGT
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Basic Phosphatase
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
HbA1c
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
P-glucose
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Albumin
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
CD163
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Platelets
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Uric Acid
Time frame: Mean changes from baseline to 10-weeks (post camp intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38724826Jakobsen 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.
- Results publication: PubMed 38705820Jakobsen 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.
- Results publication: PubMed 40157300Pauls 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.
- Results publication: PubMed 37777600Aagaard 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.
- Results publication: PubMed 37285233Orry 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.
- Derived from this study: PubMed 42159618Christofersen GD, Pauls DD, Bruun JM. Appetitive traits and long-term risk of disordered eating: a 3-year follow-up in children with overweight and obesity. Eat Weight Disord. 2026 May 20;31(1):68. doi: 10.1007/s40519-026-01868-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens M Bruun, Professor principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet with a higher amount of protein (25E% per day), Increased follow-up contact after the 10-week intervention and Diet with a lower amount of protein (15E% per day) in people with Childhood Obesity and Overweight and Obesity, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index Standard Deviation Score (BMI-SDS) (time frame: Mean changes from baseline to 10-weeks (post camp intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522921, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.