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
Phase: NA
Conditions: Childhood Obesity, Overweight and Obesity, Adolescent Obesity, Adolescent Overweight, Diabetes
Sponsor: University of Aarhus

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Childhood Obesity – Prevention of diabetes through changed Eating 
Patterns (The COPE-study): A non-randomized trial investigating the 
efficacy of dietary changes in protein 
 
Dorthe Dalstrup Pauls (former Jakobsen)1,2, Lea Brader3 and Jens Meldgaard Bruun1,2 
 
1 Department of Clinical Medicine, Aarhus University 
2 Steno Diabetes Centre Aarhus, Aarhus University Hospital  
3 Global Nutrition, Arla Foods amba, Agrofoodpark 19, 8200, Aarhus N, Denmark 
 
 
Clinical trial registration 
Preregistered and published at clinicaltrials.gov with ID: NCT04522921 (initial release 13th 
August 2020). 
 
Document date: 8th January 2021.  
NB: As a result of the COVID-19 pandemic (impacting the study from December 2020 to 
February 2021), the study arms have been renamed in the protocol to enhance the clarity and 
interpretation of the study design and results. 
 
 

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Background 
Globally, the prevalence of childhood obesity has increased by ~50% from 1980 to 2013(1). In 
children and adolescents overweight and obesity are classified by an age-and- sex adjusted BMI. 
The World Health Organization (WHO) defines overweight by a BMI-SDS greater than 1 
standard deviation (SD) and obesity by a BMI-SDS greater than 2 SD(2). This is equivalent to an 
ISO-BMI (ISO-BMI = the weight in kilograms divided by the height in meters squared) greater 
than or equal to 25 kg/m2 and greater than or equal to 30 kg/m2(3). The most marked increase in 
childhood obesity has been observed in high-income countries, however, in the last part of the 
time-period a substantial increase has also been observed in middle- as well as low-income 
countries(1, 4). The Danish trends for childhood obesity are comparable to other high-income 
countries and in 2018, the Danish Health Authorities reported that 2.7% of children at age 7-13 
years, 3.2% at age 14-15 years, and 3.9% at age 16-18 years were considered to be obese. For 
comparison, 16.8% of the adult Danish population is considered obese(5). 
The development of childhood obesity is both complex and multifactorial depending on a 
combination of genetic/maternal, psychosocial, and environmental factors(6). Obesity in 
childhood and adolescence is highly predictive of continuous obesity into adulthood(7) and 
furthermore, associated with an increased risk of developing diseases such as type 2 diabetes 
(T2D), cardiac arrhythmias, premature stroke (age <55 years) and coronary heart disease (both 
non-fatal and fatal events) in adulthood as compared to never obese children(8-11). In addition, 
compared to their lean peers, children with obesity have in general lower self-esteem, more 
loneliness and a decreased quality of life (QoL), which is comparable to that of children with 
chronic diseases such as diabetes and cancer(12, 13).  
Treatment or attenuation of obesity in children and adolescents can be obtained in various ways 
such as lifestyle interventions (i.e. changes in diet and physical activity), pharmacotherapy and 
bariatric surgery. As an adjunct to lifestyle intervention, pharmacotherapy could be an option, but 
only a few short-term (<6 months) studies have been performed. Recently, Liraglutide 3.0mg 
treatment for 7-13 weeks was found to significantly reduce BMI Z-score by –0.28 in a population 
of 7-11 years old children with obesity (isoBMI >30 kg/m2)(14). However, in the same study 
37.5% vs. 12.5% in the placebo group experienced gastrointestinal side effects. Taking the 
possible adverse effects and the modest weight loss effects into account, these studies have had 
somewhat discouraging results and more long-term studies are needed(14, 15). Bariatric surgery 
is well-established as an obesity treatment in adults leading to weight loss and weight loss 
maintenance(16). Bariatric surgery is rarely performed in children and adolescents. In a study in 
adolescents with up to 5 years of follow-up, bariatric surgery was found to induce a weight 
reduction of 26%, comparable to the 29% found in adults(17). Despite comparable weight change 
5 years after bariatric surgery, adolescents were significantly more likely to obtain remission of 
diabetes and hypertension as compared to adults, although both groups were still severely obese 
(BMI ~37kg/m2) at that time point(17). However, in the same study, the rate of reoperations and 
nutritional problems were significantly higher in the adolescents, a finding that is comparable to 
another study in which ~25% of the included young subjects (13-18 years of age) underwent 
additional abdominal surgery due to complications and ~70% displayed nutritional 
deficiencies(17, 18). Due to the invasive and somewhat discouraging results of pharmacotherapy 
and surgery in children and adolescents with obesity, lifestyle interventions seem to be a 
preferable and safe treatment option. 

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The literature on dietary intake and differences in macronutrient composition primarily comes 
from studies in adults. In adults, comprehensive studies in large cohorts have found that high 
intake of carbohydrates was associated with higher risk of total mortality and inversely, that 
higher intake of fruit, vegetable, legume, and dairy products was associated with a lower risk of 
total mortality(19-21). In line with the latter findings, total intake of fat as well as subtypes of fat 
(including saturated fat) was associated with lower risk of total mortality(19). In relation to 
carbohydrate intake it was recently suggested that the carbohydrate quality is of significant 
importance in relation to development of disease and there seem to be a dose-response 
relationship between the intake of dietary fiber, whole grain, and all-cause mortality as well as 
the development of non-communicable disease such as T2D, cardiovascular disease, and certain 
cancers (e.g. colorectal and breast cancer)(22, 23). In addition, intake of whole grain, fruit, and 
legume was reported to be inversely associated with the development of overweight and obesity 
in adults, and sugar-sweetened beverages to be the opposite, although the quality of evidence was 
low(24). In relation to weight loss and especially weight loss maintenance, protein, including 
dairy protein, seems at least in adults to be of importance(25). In children and adolescents, a 
recent systematic review found that caloric restriction down to a 50% reduction in estimated daily 
energy requirement resulted in a mean weight loss of ~10kg with a sustained weight loss of ~5kg 
after 5-14 months, with the most pronounced effect in adolescents (10-18 years)(26). Only two of 
the 24 studies included in this review reported on psychological well-being and found 
improvement in QoL. Only one of these reported on changes in eating behavior and found no 
effect on eating behavior(26). Few studies have investigated the effects of macronutrient 
composition in diets designed for weight loss in children and adolescents. Some report similar 
results on weight loss whether low carbohydrate or low fat was applied (27). Some report a 
beneficial effect of a high-protein/low carbohydrate diet compared to a low-fat diet on weight 
loss in severely obese children (28) and one recent meta-analysis found dairy products to be 
associated with a decreased risk of developing obesity in children(29). Other studies in children 
have reported conflicting results on supplementation with increased dietary protein as a way to 
obtain weight loss and/or reduce hunger when exposed to caloric restriction(30-32). 
Dietary studies in children and adolescents on weight loss or weight loss maintenance combined 
with measures of QoL, including eating behavior and eating habits, are scarce. Therefore, the 
purpose of the present study is to perform a 10-week dietary intervention study with a follow-up 
after 52 weeks in children from 7-14 years of age with overweight or obesity in a multi-
component overnight camp setting. In a caloric restricted and increased physical activity setting, 
the control group will consume a low-moderate protein diet (15 energy percent (E%)/day) 
whereas the intervention group will consume a higher protein diet (25E%/day).  
Aims 
1. To test whether a diet with higher consumption of protein-containing foods is more 
favorable than the current weight-loss diet served to children and adolescents in the 
setting of a multi-component overnight camp (Julemærkehjem) on:  
a. Anthropometry (BMI-SDS, fat-mass, fat-free masse) 
b. Metabolic, inflammatory and liver markers. 
c. QoL, eating behavior, eating habits and overeating/loss of control eating episodes. 

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Hypotheses 
Compared to the current weight-loss diet, we hypothesize 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 risk factors for type 2 
diabetes. Furthermore, we hypothesize that QoL will improve during the intervention and in 
relation to weight loss. 
Study setup 
The COPE-study is a non-randomized trial and a collaboration with the staff of the multi-
component-overnight camps (Julemærkehjem) in Denmark. The multi-component-overnight 
camps are well-established intensive weight loss camps to which Danish schoolchildren, from 7-
14 years of age, are referred to for 10-weeks intervention focusing on a healthy lifestyle, healthy 
eating, new habits and increased physical activity. 
 
Participants 
A total of 350 children attending a multi-component overnight camp in Hobro and Fjordmark for 
10 weeks will be invited to participate in the study. The capacity is 48 children in camp Hobro 
and 30 children at camp Fjordmark, and every 2nd or 3rd week new children start camp in groups 
of 8-12 children. Annually, 240 children attend camp Hobro and 150 children attend camp 
Fjordmark. 
 
Parent/guardian will be co-participants and help their child answer questionnaires. One time, in 
the initial period of the study, parent/guardian will be asked to report their weight (kg) and height 
(m) and parents will be asked health-related and family-related questions. Furthermore, at least 
one parent/guardian will participate in the nutrition education class at the multi-component-
overnight camp with their child.  
Recruitment/consent 
The camp staff manage the visitation of the children. At the first visit (pre-visit), which is an 
individual meeting at camp held behind closed doors with one of the camp staff, the 
parent/guardian will be asked to sign one written consent to participate themselves and one 
written consent for their child to participate. Furthermore, they will give oral consent if both 
parties want to participate in the trial.  
 
We want to invite all the participating children and parents/guardians to a follow-up meeting 3 
years, 5 years, 7 years and 10 years after the intervention to measure anthropometry and to 
answer questionnaires. Also a blood test will be collected from all participating children who 
voluntarily agrees to a blood test. When the children turn 18 years old, we will provide written 
and oral information to the adolescents and collect independent written and oral consent from the 
adolescent to continue to participate in the study.     
 
Participants can be included if:  
• The child start 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.  

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• Parent/guardian has submitted oral and written consent to participation of their child. In 
case of shared custody both parents must submit oral and written consent to participation 
of their child. If one parent is not present at the first visit at camp, this parent must send a 
power of attorney with the other parent.  
Participants will be excluded if:  
• The child has a disease, diagnose or eating disorder that requires a special diet.  
• 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.   
 
Methods 
The camp staff will assign the participating children to one of three different groups (see 
specifications below). The assignment of children to the various groups will therefore be blinded 
for the research group.  
 
• SARS CoV-group: The children attending camp Hobro from October 2020 to April 2021 
were affected by a COVID19 lockdown of the camps and sent home for 5 weeks with no 
control of diet and physical activity. 
• Control group: The children attending camp Fjordmark from May 2021 to June 2022 will 
receive the current weight-loss diet (low to moderate protein diet equal to ~15E%/day) for 
the 10 weeks they attend camp. After leaving the camp, the children and their families 
will be contacted once every month within the first 6 months and one time halfway 
between 6 months and 52-weeks follow-up (7 times total). The families will be contacted 
by phone, face-time, skype as they prefer (see specifications below). 
• Protein group (PG): The children attending camp Hobro from May 2021 to March 2022 
will be served a higher protein diet equal to ~25E%/day for the 10 weeks they attend 
camp. After leaving camp they will receive written guidelines and be instructed how to 
continue a higher consumption of protein-containing foods at home until 52-weeks 
follow-up. After leaving camp, the children and their families will be contacted once 
every month within the first 6 months and one time halfway between 6 months and 52-
weeks follow-up (7 times total). The families will be contacted by phone, face-time, skype 
as they prefer (see specifications below). 
The trial design is shown in Figure 1, below. 

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Figure 1: Trial design 
The COPE-Study intervention components 
Dietary intervention 
The dietary intervention at the multi-component overnight camp uses the official Danish dietary 
guidelines as basis (33, 34). In all three groups the daily energy intake will be between 1200-1800 
kilocalories (kcal) depending on age and gender and a number of foods are limited and restricted 
for the children during the 10 weeks they attend camp. In the CG and the SARS CoV-group, the 
protein intake will be ~15E%/day and in the PG the protein intake will be aiming at ~25E%/day. 
In the PG carbohydrates-rich foods at breakfast and two in between-meals will be replaced by 
protein containing foods (e.g. dairy products) to make the intervention isocaloric.  
The kitchen staff serving meals to the CG will be instructed to continue their usual fixed weight-
lost diet plan. Likewise, the kitchen staff serving meals to the SARS CoV-group  will be 
instructed to continue their usual fixed weight-loss diet plan.  
The kitchen staff serving meals to the PG will be instructed how to replace some meals by protein 
containing foods and be responsible for including the predetermined amount of protein foods in 
the diet plan. After leaving camp the children in the PG will be instructed how to consume 
protein containing foods as part of their diet until the 52-week follow-up.  
 
Nutritional education class 
All children and their parents will three times total (3-5 weeks before camp; 4-6 weeks into camp; 
4-8 weeks after camp) be invited to camp in groups of 8-12 families. All three days they will 
learn about healthy eating and nutrition.   
 

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The CG will be introduced to the official Danish dietary guidelines (33, 34) and be introduced to 
different foods and recipes to promote healthy eating. The nutritional education class will be an 
oral presentation performed by the kitchen staff at camp and each session will last 10-15 minutes. 
 
The PG will also be introduced to the Danish dietary guidelines (33, 34) and be introduced to 
different foods and recipes to promote healthy eating before and after camp. During camp the PG 
will learn about protein relative to weight loss, satiety and physical activity and furthermore, they 
will learn how to identify macronutrients, especially protein, in foods. Knowledge of protein and 
macronutrients will be communicated through story-telling, games and by showing examples of 
protein containing foods and meals. This session will be held by the primary investigator and last 
20-30 minutes.  
 
Follow-up intervention 
Children and their families attending the PG and the CG will be contacted once every month 
within the first 6 months' after camp and one time halfway between 6 months and 52-weeks 
follow-up (7 times total) by the primary investigator.  
The conversation with the CG will be about successes and challenges (e.g. concerning healthy 
eating and physical activity) after camp and the child and their parent/guardian will choose 1-3 
issues which they feel is challenging after camp. Those issues will be the main focus at the next 
follow-up conversation. Likewise, the following follow-up conversations will be based on issues 
reported as challenging at the last conversation.  
The conversation with the PG will primarily focus on protein consumption and before the 
conversation they will be asked to answer a food frequency questionnaire on protein foods. The 
primary investigator will motivate the children in the PG to continue eating protein until 52-
weeks follow-up.  
All children and their families will be contacted by phone, face-time or skype, as they prefer, 
within a predetermined and known timeframe, and the follow-up conversation will last 
approximately 10 minutes.  
In case of none response the children and their families will receive an SMS reminding them to 
be in contact with the primary investigator within the week.  
Outcome measurements 
The primary outcome measure is BMI-SDS (35) which will be compared between the CG and the 
PG. BMI will be calculated (kg/m2) and weight categories defined using age- and sex-specific 
BMI-cut-offs from 2007 WHO references (35). Body weight (kg) and fat-free mass/fat-mass will 
be measured according to standard procedures by using a Bioelectric impedance (InBody model 
270). Height (m) will be measured using a fixed wall measuring tape.  
 
Teachers at the multicomponent overnight camps will be instructed how to measure 
anthropometrics and be responsible for measuring children. Children will be measure three times 
total; at baseline, 10-weeks and 52-weeks.  
One participating parent/guardian will self-report their height and weight at baseline. All 
measurements are recorded to the nearest 0.1 kg and 0.1 cm.  
Additionally, after resting in a chair, all children will have their blood pressure measured at 
baseline, 10-weeks and 52-weeks. Blood pressure will be measured with the right arm placed at 
heart level using an automatic non-invasive blood pressure monitor (Omron M3 model). Camp 

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staff will be instructed how to measure blood pressure correctly and note three measurements at 
each event from which an average will be calculated. 
A blood test will be collected three times total; at baseline, 10 weeks and 52 weeks, from all 
participating children who voluntarily agrees to a blood test. The blood test will be collected to 
measure relevant metabolic-, inflammatory- and liver markers. 
Questionnaires 
Background characteristics will be assessed by a self-developed parent-reported questionnaire 
with questions concerning parental education, household income, diseases in the family (T2D, 
hypertension, lipid disorders, ischemic heart disease, thyroid disease), child and parent 
participation in physical activity (leisure time, sports), ethnicity etc. 
 
Quality of Life will be measured using the Children PedsQL4.0 (36) questionnaire, which is a 
child-reported questionnaire containing 23 questions.  
 
Children’s eating habits will be measured using the Children’s Eating Habits Questionnaire-FFQ 
(CEHQ-FFQ), which is a parent/child-reported questionnaire containing 36 questions (37). Parent 
and child are encouraged to answer this questionnaire together because it is difficult for the 
parent/guardian to know exactly which foods their child eat during school and leisure.  
 
Children’s eating behaviour will be measured using the Child Eating Behaviour Questionnaire 
(CEBQ), which is a parent-reported questionnaire containing 35 questions (38). 
 
Children will be asked two questions (see below) from the Eating Disorder examination 
questionnaire (EDE-Q 6.0) (39) to investigate overeating/loss of control eating episodes and the 
risk of developing binge eating disorder (BED).  
• No. 13: Over the past 28 days, how many times have you eaten what other people would 
regard as an unusually large amount of food (in relation to your size and age)? 
• No. 14: … On how many of these times did you have a sense of having lost control over 
your eating (at the time you were eating)? 
Details on the distribution of questionnaires are outlined in Figure 2, below.  
Questionnaires will be delivered to the participants using REDcap. 

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Figure 2: Distribution of questionnaires 
Patient health records 
We do not need to access patient health records to complete this study.  
 
Compensation scheme/Insurance  
Within the whole study period the participants will be covered by the Act on Complaints and 
Compensation Access within Health Care (cf. legislation number: 1113 07/11/2011 
www.retsinformation.dk). The participants in the trial are covered by the patient compensation 
scheme. 
 
Publication of results 
Positive, negative and inconclusive results from the COPE-study will be submitted for publication 
in peer-review journals with Dorthe Dalstrup Jakobsen as first author and presented at scientific 
conferences from the beginning of year 2023, when some parts of the data are analysed. All analysis 
and the trial are expected to be finished in 2032. This study is registered and published at 
clinicaltrials.gov with ID: NCT04522921. All participants will be anonymized in the publication 
of results.   
 
Ethics 
All parts of the COPE-study will be performed in accordance with good clinical practice and 
conforming to the Declaration of Helsinki. The protocol is approved by the local Committee of 
Ethics (journal number: 1-10-72-73-20) and the data entering the project will be safeguarded using 
REDCap database at Aarhus University securing the General Data Protection Regulation. The Data 
Protection regulation and the Data Protection Act will be complied by all involved parties, 
researchers and camp staff, when handling trial data. Furthermore, the trial is registered internally 
at Aarhus University.  
Before participation, the nature, purpose and potential risks of the study will be carefully 
explained to all children and their parents/guardians. All participating children will be invited to 
follow-up 3 years, 5 years, 7 years and 10 years after the intervention to measure anthropometry 

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and to answer questionnaires. Also a blood test will be collected from all participating children 
who voluntarily agrees to a blood test 3 years, 5 years, 7 years and 10 years after the intervention. 
When the children turn 18 years old, we will provide written and oral information to the 
adolescents and collect independent written and oral consent from the adolescent. Participants 
may at any time withdraw from the study without any reason given. All information obtained in 
the study will be treated as confidential and national authorities will have access to the data if 
requested.  
 
Significance of the project  
The results on weight loss/weight maintenance, biomarkers, QoL, eating habits, eating behaviour 
and overeating/loss of control eating episodes will provide important information for future 
weight-loss programmes and report on the effects of increased consumption of protein-containing 
foods as part of an overall weight-management setting. The access to prospectively follow the 
cohort and compare the participating children to the other Danish children using a register-based 
approach will provide invaluable information on the long-term development of disease (e.g. T2D) 
and various psychosocial factors. 
Power calculation and statistics 
The power calculation was based on a previous study investigating the effect of a higher protein 
intake (21E% vs. 32E%) on childhood obesity (28). In this study, 22 and 24 children were 
allocated to the standard and high protein diet, respectively. Both groups had a reduction in BMI 
z-score during the 13-week intervention (from 2.48 ± 0.06 BMI-z to 2.10 ± 0.10 BMI-Z in the 
high protein group, and from 2.51 ± 0.05 BMI-Z to 2.40 ± 0.10 BMI-Z in the standard protein 
group), with a greater reduction in the high protein group (p = 0.03). The number of participants 
needed to detect a between-group difference of − 0.27 SD with a power of 80% and a 
significance level of 5% was calculated to be ~ 55 children in each group. Preferably, unadjusted 
mixed effects models will be performed to investigate differences in change between the groups. 
 
Economic/funding 
The multi-component-overnight camps are financed with the revenue from public sale of Christmas 
stamps, funding from investors and private companies. The organization behind the camps will 
provide facilities and staff to help implement and manage the intervention.  
The project is funded by an unrestricted grant from Arla Foods Amba on 970,593 Danish kroner 
(130.000 EUR). Tests, test-instruments, other test-personnel such as bioanalysts, project materials 
for information, education e.g. and the salary of the primary investigator will be funded by the 
grant, and payments will continuously be paid as costs arise.   
The research team declare no financial interest or affiliation with Arla Foods Amba.  
Project group 
Primary investigator: 
Dorthe Dalstrup Pauls, PhD, MSc, Department of Clinical Medicine, Aarhus University and 
Steno Diabetes Center Aarhus, Aarhus University Hospital  
Principal supervisor: 
Jens Meldgaard Bruun, chief consultant and professor, Department of Clinical Medicine, Aarhus 
University and Steno Diabetes Center Aarhus, Aarhus University Hospital 
Co-supervisor: 

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Lea Brader, MSc, PhD, Nutrition Scientist, Global Nutrition, Arla Foods amba, Agrofoodpark 19, 
8200, Aarhus N, Denmark 
 
 
 

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